Job Title:  Assistant Director/Director, CMC

Department:  Regulatory Affairs

Location:  Shanghai

 

Responsibilities

  • Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations
  • Support the preparation of CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness
  • Ensure timely preparation and management of all necessary documentation for regulatory submissions
  • Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines
  • The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations
  • Responsible for establishing and maintaining internal filing template and ensure submission quality and consistency
  • Represents WuXi Biologics in interactions with Regulatory Agencies and clients’ RA CMC representatives.

 

 

Qualifications

  • The candidate must demonstrate solid working knowledge of biologics development processes.
  • Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required
  • The candidate must be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).
  • The candidate must have expertise in Chinese FDA regulations and experience interacting with CFDA. The candidate must be fluent in Chinese both written and oral
  • Minimum BS degree in one of the relevant life sciences is desirable. Advanced degree and RAC certification are pluses.
  • BS degree with 8-10 years’ experience
  • MS degree with 5-8 years’ experience
  • PhD degree with 3-5 years’ experience

 

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Senior/Executive Director, Quality Control

Department:  Analytical Science

Location:  Shanghai

 

Responsibilities

  • Lead Quality Control Organization including Biochemistry, Physicochemistry, Microbiology and Environmental Monitoring, and Stability groups to perform in-process, lot release and stability testing for early and late stage programs.
  • Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation and promote collaboration with partner organizations.
  • Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of GMPs and quality systems with experience managing deviation, change control, and CAPA. Assist regulatory audit and inspections.
  • Lead quality control system improvement initiatives. Projects may include writing and reviewing QC SOPs, designing and implementing systems (LIMS, E-notebook etc.).
  • Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs.
  • Develop talent, inspire innovation and operational excellence and foster a continuous learning and improvement environment.
  • Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
  • Should be an effective communicator of ideas, project goals and results to cross-functional team members.

 

Qualifications

  • Requires a Ph.D. in analytical chemistry, biochemistry, or related life sciences degree and 12+ years of relevant experience that demonstrates an expertise in assay qualification/validation, release and stability testing and QC operations.
  • Extensive hands-on experience in biochemistry, HPLC/CE and QC operations in cGMP environment.
  • Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
  • Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
  • Experience interacting with clients and health authorities (CFDA, FDA, EMA etc.) preferred.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:  Associate Director/Director, Biochemistry Lab

Department:  Analytical Science

Location:  Shanghai

 

Responsibilities

  • Lead Biochemistry Lab in development of immunoassay and DNA assays activities for protein therapeutics for early and late stage programs, including method development, qualification/validation, method transfer to QC, and strong collaboration with partner organizations.
  • Lead the efforts in applying high-throughput workstation and analytical technology to support process development.
  • Contribute to draft and review of regulatory submissions including INDs and BLAs.
  • The applicant will manage a large group of scientists, he/she should be an effective communicator of ideas, project goals and results to group members.
  • Strong knowledge of GMPs.
  • Hands-on technical leadership of all aspects of anti-host cell protein ELISA, anti-product ELISA and qPCR assay development.
  • Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.

 

 

Qualifications

  • Requires a Ph.D. in biochemistry, or immunology and 8+ years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
  • Industry experiences in the development and validation of ELISA and DNA assays for CMC applications.
  • Experiences with high throughput workstation and its applications.
  • Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
  • Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
  • Experience interacting with health authorities (FDA, EMA etc.) is a plus.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Senior Manager/Assistant Director, Project Management

Department:  Analytical Science

Location:  Shanghai

 

Responsibilities

  • Collect and analyze resource allocation and utilization data on all projects within Department of Analytical Sciences to help planning and operational efficiency
  • Establish system to track project progress and help assure that critical deadlines are met
  • Familiarize and understand various aspects of analytical development activities for biologics development
  • Regularly interact with management team including department head and various laboratory heads and project analytical leads
  • Facilitate management team meetings and coordinates cross-functional team meetings
  • Keep detailed records and follow up on action items to ensure timely execution
  • Cooperative and respectfully communicate with external and internal customers

 

 

Qualifications

  • MS or Ph.D. in Chemistry, Biochemistry or other related life sciences degree with 3+ years of biopharmaceutical industry experiences
  • Excellent understanding of project management processes and procedures
  • Strong critical thinking, scientific reasoning and problem solving skills
  • Be proactive with demonstrated leadership
  • Excellent in time management, organizational and multitasking skills
  • Excellent oral and written communication skills in both English and Chinese
  • Strong Microsoft Project, Word, PowerPoint and Excel skills and other computer skills

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:  Director, Downstream Development

Department:  Clinical Manufacturing

Location:  Wuxi

 

Responsibilities

  • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
  • Execute and/or oversee the process scale-up and technology transfer between the process development team and manufacturing team.
  • Lead and execute the preparation of dossiers and data packages to assist with the interactions with Regulatory agencies.
  • Assist the functional head to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
  • Coach and lead his/her team staff on the process development and validation.
  • Manage his/her team effectively in a fast paced environment.

 

 

Qualifications

  • MS with 8+ years, or PhD with 4+ years downstream process development experience.
  • At least 2 years’ people management experience and having strong management and leadership skills.
  • Good communication skills (verbal and written) in Chinese and English.
  • Skilled in Downstream process development, knowing all modes of chromatography,  various modes of filtration (dead end filtration, tangential flow filtration, viral removal filtration), and how to assemble various steps into a purification process.
  • Skilled in Design of Experiments.
  • Have a good deep understanding of the limitations of manufacturing when designing purification processes.
  • Skilled in downstream process scale-up, technical transfer, and production
  • Experience in downstream process characterization and validation.
  • Skilled in working with the cross-functional teams.
  • Familiar with budgeting processes for projects, personnel, equipment and lab space.
  • Experience in regulatory submission to CFDA, FDA, and EMA.
  • Interest in exploring cross-functional career opportunities

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:  Associate Director/Director,

Department:  Business Strategy and Operation

Location:  Wuxi

 

Responsibilities

  • Support the formulation of strategic initiatives that drive continuous growth for the company in the next 5-10 years. Interact and align with internal stakeholders to ensure the effective execution of action plans.
  • Contribute to the development and execution of global expansion plan for the company through external partnership and acquisition.
  • Host client and investor visit and present overview of company introduction and technology capability, lead a general facility tour if needed.
  • Manage and coordinate business operation activities of CEO Office, including but not limited to senior staff and board meetings, corporate events, client and investor visits, and business improvement initiatives.

 

Qualifications

  • Advanced Degrees in life science or engineering with 2-5 year experience in the pharmaceutical or biotech industry, prior business training is a plus.
  • Basic understanding of biological drug development with solid experience in one or more of the following fields: discovery, development, and manufacturing. Experience within in a fast-paced and matrix environment is preferred
  • Ability to work independently with limited supervision and as a team member.
  • Excellent verbal and written communication skills, strong multi-tasking and prioritization capability
  • Interest in exploring cross-functional career opportunities

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to WuXiBIO_Recruiting_Overse[email protected]

 

 

Job Title:  Associate Director, Validation

Department:  Process engineering and validation

Location:  Shanghai/Wuxi

 

Responsibilities

  • Support the formulation of strategic initiatives that drive continuous growth for the company in the next 5-10 years. Interact and align with internal stakeholders to ensure the effective execution of action plans.
  • Contribute to the development and execution of global expansion plan for the company through external partnership and acquisition.
  • Host client and investor visit and present overview of company introduction and technology capability, lead a general facility tour if needed.
  • Manage and coordinate business operation activities of CEO Office, including but not limited to senior staff and board meetings, corporate events, client and investor visits, and business improvement initiatives.

 

Qualifications

  • Advanced Degrees in life science or engineering with 2-5 year experience in the pharmaceutical or biotech industry, prior business training is a plus.
  • Basic understanding of biological drug development with solid experience in one or more of the following fields: discovery, development, and manufacturing. Experience within in a fast-paced and matrix environment is preferred
  • Ability to work independently with limited supervision and as a team member.
  • Excellent verbal and written communication skills, strong multi-tasking and prioritization capability
  • Interest in exploring cross-functional career opportunities

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:  Group Leader/Assistant Director/Associate Director

Department:  Project Management

Location:  Wuxi

 

Responsibilities

  • Leads the project team to fulfill the contract requirement and meet the client’s need for
  • CMC development or manufacturing projects as appropriate.
  • Tracks the progress of projects and coordinates WuXi's staff and resources to meet project deadlines in a timely and efficient manner.
  • Disseminates and facilitates information flow/exchange among WuXi departments and between the client and WuXi.
  • Manage scope change in project execution and assist to sign supplementary agreement for it.
  • Holds regular internal project meetings to discuss and plan the projects.
  • Holds regular meetings with clients to update progress via teleconference or site visits as appropriate.
  • Maintains records to document all relevant communications related to projects.
  • Copies files and mails final reports.
  • Help Service Department to generate invoices and send them to the client.
  • Maintains the WuXi standard quality and format of communications (e.g. letters, proposals, reports, etc.) and overall harmonization of documentation at the corporate level.
  • Monitors timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
  • Assists with training of team members as appropriate.
  • Tracks and confirms client materials transfer information.
  • Performs other duties as required.

 

Qualifications

  • BS/MS with major in Biological Sciences, Chemical engineering, or equivalent training plus 1 or more years project management experience or equivalent training and/or experience.
  • Ability to accomplish the described duties through the use of appropriate computer equipment and software (i.e. Microsoft Word, Excel, PowerPoint, Project and Outlook) and general office equipment (i.e. photocopier, fax machine and phone equipment).
  • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages.
  • Ability to use judgment as dictated by complexity of situation.
  • Ability to work under limited supervision and to handle problems of a more difficult nature.
  • Ability to interpret written instructions and to write form letters and routine correspondence.
  • Ability to understand and follow verbal or demonstrated instructions.
  • Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
  • Ability to prioritize tasks in fast paced work environment.
  • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
  • Ability to build rapport with internal co-workers and clients in such a way as to maximize quality of client service..

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

Job Title:  Senior Scientist of Biologics Conjugation Department

Department:  Conjugation Department

Location:  Shanghai

 

Responsibilities

  • Keeping updated biotech knowledge/information
  • Having capability to design/develop novel conjugation related methodology
  • Individually designing and carrying out research projects proposed by customers;
  • Leading more complicated projects;
  • Communicating well with different functionalities and coordinating inter-departmental or inter-group activities;
  • Communication and discussion with customers;
  • Data analyses and report-writing;
  • Other activities such as safety and IP protection.

 

Qualifications

  • PhD or equivalent in organic chemistry/biochemistry/analytical chemistry, or PhD or equivalent in biological sciences;
  • Having at least two years of protein-working experiences, including those in protein purification and characterization;
  • Having experience in purification/analytical instruments;
  • Fluent oral and written English;
  • Self-driven and result-oriented, proactive and strive for the best;
  • Team player.
  • Enthusiastic and scientific oriented
  • Positive attitude and hard worker with efficiency

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

 

 

Job Title:  IND-enabling Program Management

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Manage, direct and lead preclinical projects in a team environment; Work with clients to proactively identify the right strategy based on their unique program and help clients to select right studies, smartly coordinate the studies to move forward efficiently
  • Monitor closely the progress of the project, coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issuers and input the constructive suggestions
  • Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development; Communicate directly (visiting host, holding TC and auditing, etc.) with national and international sponsors
  • Service as an expert for all TOX-related discipline within TAD; Prepare documents package for IND filing; Search and prepare scientific references for project needs.
  • Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.

 

Qualifications

  • PhD or equivalence in biomedical/ pharmaceutical science with at least 5 years experience in pharmaceutical/biotech industry in preclinical development with strong toxicology expertise.
  • Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration;
  • Familiar with relevant FDA, ICH, EMA/OECD and CFDA guidelines/regulation with hands-on experience on planning and execution of IND/CTA programs
  • Team oriented work ethic and ability to work in cross-functional teams
  • Excellent written and oral communication skills
  • Regulatory writing experience and PMP certification will be a pluss.
  • Ability to build rapport with internal co-workers and clients in such a way as to maximize quality of client service

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Assistant director-B cell and NGS

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • The candidates will have extensive theoretical knowledge as well as bench level experience in the identification and characterization of mAb using various techniques, such as library display (e.g. yeast, phage, etc), B- cell cloning and NGS method
  • The candidate will be responsible for establishing and executing novel antibody discovery platform for generating antibody leads.
  • The candidates will have good organizational and documentation skills and the ability to plan and simultaneously execute multiple antibody discovery projects.
  • Industry experience is strong preferred but not absolutely required for the position

 

Qualifications

  • MS with > 5 years or PhD with > 2 years of relevant experience in therapeutic antibody lead generation through cell-based methods. Expertise in one of the following areas:
  • B cell repertoire analysis using Next Generation Sequencing and molecular biology for antibody discovery.
  • Hand on experience on cell culture and B cell cloning techniques for antibody discovery.
  • Experience in the development of novel antibody discovery platforms.
  • FACS sorting, single cell RT-PCR or B cell culture.
  • A strong motivation in pursue science in drug discovery.
  • Adaptable and productive in a fast-paced environment
  • Good communication skills required, including writing notebooks and presentation in English.
  • Strong team-working spirit and excellent communication and inter-personal skills.
  • Doctor degree in related Life Science subjects with >2-3 years related experience, or Master degree with > 5 years of industrial.
  • Knowledge in immunology,especially B cell immunology
  • Applied knowledge of library construction and library display.
  • Experience in antibody affinity maturation or humanization.
  • Proficiency in applications of deep sequencing technologies.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Senior/Principal Scientist of Purification 

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Hands on experience in recombinant protein and IgG purification with AKTA, as well as column packing and evaluation.
  • Previous experience in process optimization and verification with endotoxin controlling.
  • Familiar with protein analytical technology such as but not limited to HPLC (SEC, IEX) and WB.
  • Experience in automation purification, ability to edit method is a plus.
  • Previous experiences in protein/IgG formulation.
  • Maintain the latest technologies in protein purification, and willing to adopt new techniques into the routine operation.
  • Communicate with director about work and maintain the experiment result with superior quality, and coach new technician.

 

Qualifications

  • At least BS in protein science or related discipline with at least two years focused experience in protein purification and formulation with extensive chromatographic operation in AKTA is required.
  • A thorough understanding on expression, refolding, purification, and analytical techniques for protein quality and quantitation.
  • Good communication skill in English.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Scientist of Antibody Engineering 

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Performs antibody engineering tasks including antibody library construction, affinity maturation.
  • Performs molecular biology tasks including PCR amplification, restriction cloning, bacterial culture, sequence analysis and ELISA/FACS.
  • Operates and maintains equipment and instruments.
  • Analyzes, interprets, summarizes, compiles data and presents internally.
  • Keeps appropriate experimental records and documentation.
  • Other responsibilities may be added at the company's discretion.

 

Qualifications

  • Hands-on experience in antibody engineering and antibody library construction
  • Strong skills in molecular biology, biochemical, and immunochemical techniques (ELISA, FACS, molecular cloning) are highly desirable.
  • Thorough understanding of antibody structure/function and antibody engineering concepts.
  • High degree of motivation and strong communication skills required.
  • Master’s Degree in Molecular Biology, Cell Biology or a related discipline.
  • Minimum 2 years relevant experience in academia or biopharmaceutical sector.
  • Excellent organizational and communication skills, a keen attention to details and controlling the development from a holistic viewpoint.
  • Safety procedures must be strictly followed at all times.
  • Signing and compliance with the company’s Confidentiality and Non-compete Agreement is a condition of employment.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

Job Title:   Scientist of phage library selection   

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Select antibody from phage library, include panning & screening (ELISA & FACS, etc), data & antibody sequence analysis, generate final report;
  • Deliver and make update/summary timely;
  • Work with colleagues to ensure data quality, efficiency/timeline;
  • In addition to follow company compliance policies, work on the projects to practice good LabNotebook writing;

 

Qualifications

  • Molecular biology, biochemistry or related background, Master or bachelor with more than 2 years’ experience;
  • Experience with phage or other display libraries;
  • Understanding of antibody discovery process;
  • Experience with antibody discovery and/or engineering is a plus;
  • Experience with antibody library design/construction is a plus.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

Job Title:   Scientist of Hybridoma   

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Following SOPs, independently perform antigen preparation, animal serum ELISA titration, cell culture, hybridoma fusion and screening works;
  • Be responsible for planning and arranging and performing hybridoma related studies;
  • Responsible for notebook record, data analysis and presenting data in project meeting;
  • Be responsible to complete the tasks and other assignments in timely manner;
  • Independently plan, design and execute new project and responsible for trouble shooting and delivery task in timely manner;

 

Qualifications

  • Master or above;
  • Fluent English communication both in written and spoken English;
  • Knowledge of hybridoma technology, immunology, cell biology and molecular biology and drug discovery is required;
  • Good experience of aseptic technology, cell culture, hybridoma cell fusion, subcloning;
  • Experiences of hybridoma technology, animal immunization and antibody engineering are preferred;
  • High accountability, self-motivated, positive attitude and team player;
  • Detail-oriented, excellent execution and effective communication skill.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Scientist of High Throughput Screen

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Familiar with immuno-assays including ELISA, Flow cytometry Assay and cell culture, sterile procedures, etc.
  • Be responsible for screening assay development, optimization, planning and arranging and performing studies.
  • Responsible for notebook record, data analysis and presenting data in project meeting.
  • Be responsible to complete the tasks and other assignments in timely manner.
  • Independently plan, design and execute new project and responsible for trouble shooting and delivery task in timely manner.

 

Qualifications

  • Master or above ;
  • Knowledge of hybridoma technology, immunology, cell biology and molecular biology and drug discovery is required;
  • Good experience and skills of aseptic technology, cell culture, high-through-put screening, and immune-assay development etc. are preferred.
  • High accountability, self-motivated, positive attitude and team player.
  • Detail-oriented, excellent execution and effective communication skill.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Scientist of Phage Display

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Performs antibody phage library construction, including immune, non-immune and synthetic antibody phage library construction.
  • Performs antibody lead isolation tasks including solid, liquid, and cell-based panning of antibody phage libraries, screening and analysis of selection outputs.
  • Performs antibody engineering tasks including antibody library construction, affinity maturation, or humanization.
  • Performs molecular cloning tasks including PCR amplification, restriction cloning, bacterial culture, and sequence analysis.
  • Operates and maintains equipment and instruments.
  • Keeps appropriate experimental records and documentation.

 

Qualifications

  • Hands-on experience in phage display.
  • Strong skills in molecular biology, e.g. PCR, molecular cloning, etc.
  • Thorough understanding of antibody structure/function and antibody engineering concepts.
  • Experience with project/grant management including keeping aggressive timelines and troubleshooting experiments.
  • High degree of motivation and strong communication skills required.
  • Master Degree or above in Molecular Biology, Cell Biology or a related discipline.
  • Industry experience is strong preferred but not absolutely required for the position.
  • Safety procedures must be strictly followed at all times.
  • Signing and compliance with the company’s Confidentiality and Non-compete Agreement is a condition of employment
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Scientist/Senior Scientist of Functional Assays 

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Research on literature, propose assay strategies, design assay validation plans and perform assay development and screening studies for biochemical and cell based assays.
  • Analyze, interpret, summarize and compiles data independently. Keep appropriate experimental records and documentation.
  • Lead various assay development and antibody screening efforts preferably through active bench work.
  • Function as a project representative to coordinate and perform assays within timeline and quality requirement, be able to communicate effectively both internally or externally. Train and manage junior scientists to fulfill desired duties satisfactorily.
  • Keep compliance with all company and departmental policies.
  • Other responsibilities may be added at the company's discretion.

 

Qualifications

  • D. or M.S. Degree in cell biology, biochemistry, molecular biology or a related discipline.
  • Experience in cell-based or biochemical assay development.
  • Experience in antibody discovery and characterization, and background in signal
  • transduction and cancer biology is a strong plus.
  • Project management and communication skills including English proficiency.
  • High degree of motivation and team work spirit required.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Scientist/Senior Scientist of Immunology Group

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • You will be responsible for designing, executing and reporting the results of experiments to support projects from target identification and validation through to clinical candidate selection.
  • You will use a wide range of advanced methodologies to probe mechanisms and test drugs, primarily through in vitro and ex vivo cell-based immunological assays.
  • The successful candidate will have excellent oral and written communication skills, work well independently and as part of a team, and be able to execute on multiple projects simultaneously.
  • With limited supervision, the role includes developing and optimizing methodologies and assays and making decisions using good scientific judgment. The position is a hands-on, laboratory based role with no direct reports.

 

Qualifications

  • D. in Immunology, cell biology or related field with a minimum of 3 years’ experience in pharmaceutical/biotech industry or in an academic setting.
  • Outstanding candidates with a Master’s degree with a minimum of 7 years’ industry experience will also be considered
  • Solid training and background in cellular immunology, preferably with expertise in immune-oncology, autoimmunity, and associated rodent pre-clinical models.
  • Ability to independently design, perform and interpret data derived from cellular immune function assays.
  • Broad expertise and familiarity with assays and technologies commonly used to assess immune endpoints (e.g., MLR, antigen-specific T/APC cultures; ELISA/ELISPOT, qPCR); solid cell line and primary immune cell tissue culture skills.
  • Experience in multi-parameter FACS analysis and proficiency in downstream FACS data analysis using FlowJo.
  • Ability to organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds.
  • Basic understanding of statistics, data analysis, and assessment of reproducibility and reliability of experimental data.
  • Ability to contribute at a scientific and strategic level to drug discovery research programs in immunology, including proposal and identification/validation of novel targets.
  • S/he should be a strong team player with excellent oral and written communication skills and a demonstrated ability to work independently to design experiments, generate and interpret data, troubleshoot, and suggest next steps.
  • Demonstrated project lead experience in an academic or industrial research setting.
  • Demonstrated experience mentoring and training junior scientists.
  • Proven experience with biologics drug discovery and demonstrable knowledge of multiple large molecule formats and associated technologies.
  • Experience with in vivo immune-mechanistic or autoimmune/cancer disease models in the mouse system and their application towards pharmacological assessment of drug efficacy and mode-of-action.
  • Demonstrable experience with in vitro pharmacology assays involving large or small molecule drugs, e.g., experimental design and replication, titration and potency value determination, etc.
  • Experience with isolation, characterization, and functional testing of primary human immune cells from healthy donors or disease patient-derived materials.
  • Genetic engineering of reporter cell lines and/or primary cells: molecular biology skills (e.g., plasmid manipulation and transfection, clonal selection) and experience with gene editing technologies (e.g., si/shRNA and CRISPR/Cas9 via transfection or retroviral delivery)

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

Job Title:   Senior Scientist, Group leader or Assistant Director of In Vivo Group

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • The candidates will use a wide range of advanced methodologies through in vitro, ex vivo cell-based immunological assays, and in vivo efficacy study as well as pharmacologic study.
  • The successful candidate will have excellent oral and written communication skills, work independently as part of a team, and be able to execute on multiple projects simultaneously.
  • With limited supervision, the role includes developing and optimizing studies in vitro, ex vivo and in vivo, and making decisions using good scientific judgment.

 

Qualifications

  • BS, MS or Ph.D. in Immunology, oncology, cell biology, molecular biology, pharmacology or related fields.
  • Training and background in immunology, immune-oncology, monoclonal antibody generation, therapeutic antibody discovery, inflammation, veterinary medicine, molecular biology and/or cell biology are preferred.
  • Experienced in cell biology such as, cell culture and cell banking, including mouse and human tumor cell lines, primary cell and primary immune cell or tissue culture skills; experienced with PBMC and immune cell isolation, culture, activation, and characterization, as well as functional testing from healthy donors or patient-derived samples and murine lymphocytes.
  • Able to perform immune assays (e.g., spleen and LN isolation, lymphocyte cultures and growth, MLR, antigen-specific T activation, cytokine analysis, ELISA/ELISPOT, qPCR). Data interpretation, analysis, troubleshooting, and report writing.
  • Experience with in vivo models such as syngeneic and xenograft models in evaluating the efficacy of antibodies and small molecules, with a variety of tumor cell lines (human and mouse). Preferred with experienced in inflammation/autoimmune/tumor disease models in mouse systems, and their application towards pharmacological assessment of drug efficacy and mode-of-action. CRO experience is a plus, and experiences, such as mouse handling, drug administration, tumor measurement, blood and tissue sample collection, data analysis, and troubleshooting are considered.
  • Experienced in FACS analysis: performed staining via fluorescent antibodies in detecting cellular products such as cytokines, proteins, and other factors similar to ELISA sandwich assays; known cytometric bead array (CBA) assays use multiple bead populations typically differentiated by size and different levels of fluorescence intensity to distinguish multiple analytes. FACS assays in apoptosis, cell surface antigens (CD markers), cell viability etc. trouble shooting in FACS analysis, proficiency in FACS machine operation and software analysis such as FlowJo.
  • Specialized in staining Immunohistochemistry (IHC) in cells or a tissue section by exploiting the principle of antibodies binding specifically to antigens. The responsibilities includes sample tissue collection, embedding in medium, paraffin wax or cryomedia, sectioning, instrument operation commonly a microtome or cryostat; prepared the sample to maintain cell morphology, tissue architecture and the antigenicity of target epitopes; visualized an antibody-antigen interaction such as peroxidase etc. Troubleshooting and analysis, for example, reducing antibody cross-reactivity.
  • Experienced in PK/PD models including influence dosing, benefit, and adverse effects; emphasis on dose–response relationships, that is, the relationships between drug concentration and effect; performing studies such as ELISA; knowing data analysis with software such as WinNolin, and understanding statistical analysis with Excel, or SPSS.
  • Ability to organize and communicate complex data sets in a clear and concise manner. Willing to contribute at a scientific and strategic level to drug discovery research programs or targets in Immunology/Oncology, including proposal and reproducibility and reliability of experimental data.
  • S/he should be a strong team player with excellent oral and written communication skills and a demonstrated ability to work independently to design experiments, generate and interpret data, troubleshoot, and suggest next steps.
  • Demonstrated project-leading experience in an academic or industrial research setting. Demonstrated experience mentoring and training junior scientists for higher positions is a plus; proven experience with biologics drug discovery and demonstrable knowledge of large molecule formats and associated technologies is preferred.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Computational Structural Biologist  

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Perform bioinformatics analysis to support project progression.
  • Provide scientific support to project patent application.
  • Provide structural level interpretations on experimental data, and conduct rational design to engineer protein developability (e.g. aggregation, thermostability, etc.).
  • Conduct protein data-mining and extract statistics from public databases (e.g. PDB, NCBI database, etc.)
  • Maintain and further develop an internal protein bioinformatics platform.
  • Maintain and further develop an internal high performance computing cluster and two bioinformatics web sites.
  • Work with IT specialists to automate routine data process and workload management.

 

Qualifications

  • PhD (or equivalent experience) in structural bioinformatics, structural biology, computational biology, computational chemistry, etc.
  • Familiarity with protein sequences, structures and associated physical & chemical properties.
  • Familiarity with protein modeling and in silico design, protein engineering;
  • Experience in antibody design will be advantageous.
  • Hands-on experience on molecular modelling tools (e.g. Discovery Studio, Rosetta, Schrodinger Bioluminate, PyMOL, Gromacs, etc.);
  • Proficient in Linux working environment.
  • Experience in web development. Familiarity with HTML, CSS, PHP, JavaScript, MySQL etc.
  • Familiarity with public bioinformatics tools (e.g. BLAST, CD-HIT, HMMER etc.).
  • Excellent programming skills. Expertise in Bash scripting and Python scripting; Experience in BioPython library will be a plus.
  • Wet-lab experience will be a plus.
  • Industry experience preferred.
  • NGS data mining experience will be an advantage.
  • Excellent written and verbal skills in both English and Mandarim.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Assistant Director of Lab Operation  

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Improve the department operational systems, processes and policies in support of organizations mission -- specifically, support better management reporting, information flow and management, business process and organizational planning.
  • Manage and increase the effectiveness and efficiency of Support Services (Site Expansion, HR, IT and Finance), through improvements to each function as well as coordination and communication between support and business functions.
  • Play a significant role in long-term planning, including an initiative geared toward operational excellence.
  • Oversee overall financial management, planning, systems and controls, manage vendor budget in coordination with each function head.
  • Organization of document record for routine operation including EHS, compliance, SOP and interface workflow chart.
  • Regular meetings with function heads to align process and forecast expansion needs.
  • Supervise and coach office manager on a weekly basis.
  • Contribute to short and long-term organizational planning and strategy as a member of the management team.

 

Qualifications

  • Master or above degree in life science, biology, pharmacology, medicine or management is preferred.
  • At least 3 years experience in professional operation management.
  • Excellent computer skills and proficient in excel, word, outlook, and access.
  • Excellent communication skills both verbal and written.
  • Knowledge of contract management and Knowledge and experience in organizational effectiveness and operations management implementing best practices.
  • Demonstrated leadership and vision in managing staff groups and major projects or initiatives.
  • Excellent interpersonal skills and a collaborative management style.
  • Budget development and oversight experience.
  • A demonstrated commitment to high professional ethical standards and a diverse workplace
  • Excels at operating in an fast pace, community environment.
  • Excellent people manager, open to direction and collaborative work style and commitment to get the job done.
  • Ability to challenge and debate issues of importance to the organization.
  • Ability to look at situations from several points of view.
  • Persuasive with details and facts.
  • Delegate responsibilities effectivel.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:   Project Management

Department:  Discovery

Location:  Shanghai

 

Responsibilities

  • Strong project management experience in therapeutic antibody discovery project, including project initiation, success criteria, workflow bottleneck, technical challenges, extensive knowledge in biology and biologics discovery and translation medicine.
  • Define scope of work and generate timeline for the project while working closely with the client and internal discovery project team/leader.
  • Keep clients and project team updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
  • Forecast the project milestone from each key stage, including antibody generation, optimization, characterization and efficacy study, confirm the completion of work by stage with client and project teams and ensures workflow and progress are on track.
  • Provide the coach and development, guidance, feedback and review to the team members as needed. Participate to PM senior staff meeting and provide update on manufacture site progress status.
  • Build up strong connections of PM teams among sites of WuXi biologics discovery to develop, optimize and implement best practice. Keep alignment of client service across the company.

 

Qualifications

  • BS/MS/PhD in life science or medical science field or business management with 5-10 years of industrial working experience concentrated in project management, drug discovery, biologics discovery, and/or alliance management.
  • Have professional English skill, be able to lead business discussion and review agreements/contracts.
  • Capable of working independently in a fast-paced environment, as well as coaching and leading team by providing guidance and training
  • Good multi-tasking and prioritization skills. Strong project management experience in therapeutic antibody discovery project, including project initiation, success criteria, workflow bottleneck, technical challenges, extensive knowledge in biology and biologics discovery and translation medicine.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

Job Title:  Assistant Director/Associate Director/Director of PM

Department:  PM

Location:  Shanghai

 

Responsibilities

  • Support international and/or domestic IND filing towards BLA approval, extensive knowledge in biologics process development, tech transfer from pilot scale to clinical manufactory, and towards commercial manufactory.
  • Define scope of work and generate timeline for the project while working closely with the client and internal project CMC team/leader.
  • Keep clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
  • Forecast revenue based on contract, confirm the completion of work by stage with client and ensures revenue recognition is on track.
  • Provide the coach and development, guidance, feedback and review to the team members as needed. Participate to PM senior staff meeting and provide update on manufacture site progress status.
  • Build up strong connections of PM teams among sites of WuXi biologics to develop, optimize and implement best practice. Keep alignment of client service across the company.

 

Qualifications

  • BS/MS/PhD in science/engineering field or business management with 5-15 years of industrial working experience concentrated in project management, GMP manufacturing, Biologics process development, and/or alliance management.
  • Have professional English skill, be able to lead business discussion and review agreements/contracts.
  • Capable of working independently in a fast-paced environment, as well as coaching and leading team by providing guidance and training
  • Good multi-tasking and prioritization skills.
  • Good communication skills required, including writing notebooks and presentation in English.
  • Strong team-working spirit and excellent communication and inter-personal skills.
  • Doctor degree in related Life Science subjects with >2-3 years related experience, or Master degree with > 5 years of industrial.
  • Knowledge in immunology,especially B cell immunology
  • Applied knowledge of library construction and library display.
  • Experience in antibody affinity maturation or humanization.
  • Proficiency in applications of deep sequencing technologies.

 

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

Job Title:  Associate Director/Director

Department:  PD

Location:  Wuxi

 

Responsibilities

  • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
  • Assist the director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
  • Oversee the process scale-up and technology transfer between the process development team and manufacturing team.
  • Coach the group leads and staff on the process development and validation.
  • Manage the activities for the validation of the downstream processes.

Qualifications

  • MS with 10+ years, or PhD with 6+ years downstream process development experience.
  • At least 4 years’ people management experience
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Experience in downstream process cGMP production.
  • Experience in downstream process validation
  • Experience in working with the cross-functional teams.
  • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
  • Experience in regulatory submission to FDA/EMA.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Associate Director/Director

Department:  PD

Location:  Wuxi

 

Responsibilities

  • Overseeing assay development activities (immunoassay, or chromatography, or LC-MS) to support the development, characterization and manufacture of protein therapeutics, including method development, qualification/validation, transfer; and supervision of technical staff.
  • Work effectively with cross-functional team members, domestic and international clients to ensure that the set project goals, timelines and deliverables are met.
  • Review and approve analytical test results and reports; contribute to the draft and review of regulatory submissions including INDs and BLAs.
  • Provide oversight and guidance towards operational and technological excellence and innovation within Protein Analytical Science department.

Qualifications

  • Master or Ph.D. in biochemistry, biophysics, chemistry, molecular biology or other related fields, prefer to have some relevant experience in biopharmaceutical or biotechnology industry.
  • Excellent communication skills (verbal and written) in both English and Chinese are required. Oversea experiences or degrees would be plus.
  • Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
  • Previous managerial experience of tech staff or project is a plus.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  QA project leader

Department:  QA

Location:  Wuxi

 

Responsibilities

  • In charge of tracking quality issue during the GMP run.
  • Be responsible for customer service, keep good relationship with client.
  • Host JQA/JSC meeting with client to update manufacture progress and quality issue.
  • Lead internal/external quality issue discussion .
  • In charge of tracking related deviation/CAPA/CC.
  • Accompany client on tour site, audit, PIP.
  • In charge of relationship with PM/QA/QC/MFG.

 

Qualifications

  • At least 5 years working experience in QA area or production manufacturing.
  • Biopharmaceutical or Sterile product manufacturing experience is preferred.
  • Bachelor degree and above.
  • Biotechnology, Pharmacy or related.
  • Good in English, Fluent in spoken and written.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  QA Compliance (Sr. Manager/Assistant Director)

Department:  QA

Location:  Wuxi

 

Responsibilities

  • Oversee the quality of QA online and QA release group.
  • Act as QA Function leader for client projects.
  • Key contact person for the discussion of Quality Assurance Agreement with clients.
  • Actively involved in the communication with client regarding Quality activities conducted in the facility (such as deviation, change control, OOS, batch release etc.)
  • Timely transfer client comments/suggestion to each functional department.
  • Responsible for the creation, revision, and training on client management SOPs .
  • Responsible for GMP regulation/guidance monitoring and internal updating.
  • Other tasks assigned by the supervisor.

Qualifications

  • At least 5 years working experience in QA area or production manufacturing.
  • Biopharmaceutical or Sterile product manufacturing experience is preferred.
  • Bachelor degree and above.
  • Biotechnology, Pharmacy or related.
  • Good in English, Fluent in spoken and written.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  QC Assistant Director/Associate Director

Department:  QC

Location:  Wuxi

 

Responsibilities

  • Support daily activities of a QC Microbiology lab which performs various microbiological tests of in-process, drug substance, drug product, and environmental monitoring samples. Perform growth promotion and microbial identification if necessary.
  • Guide microbial method validation/verification and ensure the test methods in compliance with regulatory and company requirements.
  • Lead problem solving and troubleshooting; identify and resolve technical testing issues
  • Write and review study protocols, reports, SOPs, and filing documents. Review EM trending reports and EM excursion investigation reports.
  • Work collaboratively across organization and sites for microbiological related verification/validation/investigation to meet organizational goals.
  • Present project results both internally and externally as needed.
  • Initiate and introduce new scientific knowledge and keep an updated regulatory knowledge.

Qualifications

  • D. or MS in Microbiology.
  • D. with 1 + years, M.S. with 3 + years of experience in microbiology related industry experiences is desirable.
  • Knowledge of microbial identification, environmental monitoring, and microbiological testing is desired. Experience in support biopharmaceutical manufacturing is highly desirable.
  • Ability to think critically and demonstrate troubleshooting and problem solving skills.
  • Excellent interpersonal skill and verbal and written communication skills in both English and Chinese.
  • Comfortable in a fast-paced company environment and able to adjust workload based upon changing.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Upstream Training Manager

Department:  Training center

Location:  Wuxi

 

Responsibilities

  • Interact with Manufacture and Process Development groups to understand their technical competency need for new employees.
  • Build up GMP knowledge and apply to daily works.
  • To design and execute training program for new employees based upon information gathered from above.
  • Mentor and manage trainer with diverse level of experience .
  • Monitor training program progress and improve based on real lab needs.

Qualifications

  • MS degree and at least 4 years industry experience, or BS at least 6 years industry experience, Prefer having Wuxi-Biologics experiences.
  • Strong written and verbal communication skills are required, as well as ability to manage and execute programs.
  • The candidate should have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in upstream process.
  • Demonstrated understanding of the relationship between Development, Quality, and Manufacturing functions for driving technical skills to meet functional needs.
  • Familiar with current training program in each functional areas.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

Job Title:  Analytical Training Manager

Department:  Training center

Location:  Wuxi

 

Responsibilities

  • The candidate should have hands-on analytical experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in analytical and characterization skills.
  • Demonstrated understanding of the relationship between Development, Quality, and Manufacturing functions for driving technical skills to meet functional needs.
  • Familiar with current training program in each functional areas.

Qualifications

  • MS degree and at least 4 years industry experience, or BS at least 6 years industry experience, Prefer having Wuxi-Biologics experiences.
  • Strong written and verbal communication skills are required, as well as ability to manage and execute programs.
  • The candidate should have hands-on purification experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in downstream process.
  • Demonstrated understanding of the relationship between Development, Quality, and Manufacturing functions for driving technical skills to meet functional needs.
  • Familiar with current training program in each functional areas.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]

 

 

 

Job Title:  PM Manager

Department:  PM

Location:  Wuxi

 

Responsibilities

  • Define scope and build up timeline for the project while working closely with the project CMC leader.
  • Identify the critical path activities in the timeline and keep the internal staff and the client informed.
  • Coordinates the internal resources and leads WuXi's efforts for timely completion of projects by interacting with the client and internal technical staff.
  • Holds regular meetings with team members and with clients to update progress as appropriate. Response for meeting agenda, minutes and action items follow up.
  • Keep clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable means.
  • Monitor timeline and contract for accuracy and follows up on any discrepancies with clients and/or internal personnel.
  • Confirm the completion of work by stage with client and ensures invoices are sent to client for processing.
  • Act as a team leader and provide the training, guidance, feedback and review to the team members as needed.

Qualifications

  • Bachelor degree in science/engineering field with 3/5/6/8 years, or Master degree with at least 1/3/4/6 years of working experience in the pharmaceutical or industrial biotech field.
  • Experience in biological drug development and project management is preferred.
  • Good English skills, both written and oral.
  • Ability to work independently with limited supervision in a fast-paced environment.
  • Excellent verbal and written communication skills.
  • Ability to work as a team member and as a leader.
  • Good multi-tasking and prioritization skills.

How to apply:

  1. With the subject of “Apply for Job Title, Department
  2. Please sent you C/V to [email protected]