Department: ATU
Position:    Business Development Assistant Director
Report tosite GM
LocationShanghai Date: May 14, 2018
 

Job Summary:

Leads the business development activities to find and cultivate client business opportunities that result in increasing revenue for WuXi AppTec in the area of Cell and Gene Therapy manufacturing.

Essential Job Functions:

 

·         Responsible for growing revenue in the Cell & Gene manufacturing business unit.

·         Generates leads and closes business for autologous and allogeneic cell therapy, whole cell vaccine projects, gene-mediated cell therapy and gene therapy manufacturing programs in Philadelphia.

·         Represents the company and interacts with clients either at the client’s site or at a WuXi AppTec facility during client visits, and also at tradeshows/conferences.

·         Effectively communicate features and benefits and capabilities of WuXi AppTec’s manufacturing services and other associated services.

·         Follows up on all leads either generated personally, via internal/inside sales, regional account managers or senior management.

·         Collects and disseminates accurate and complete information from clients to internal technical staff to understand the scope of work.

·         Writes and develops proposals and contract templates. Works with operational staff to define project scope and combine with existing capabilities to generate the scope of work and provide timely price quotations/proposals.

·         Assists in reviewing, writing and negotiating contract terms and conditions.

·         Along with Sales Management, leads in directing the inside sales prospecting efforts.

·         Follows up on quotations for purposes of both gathering client feedback and expediting client decisions.

·         Completes paper work (i.e., sales/call reports, quote requests, and expense reports) and updates Client Relationship Management (CRM) tool in a timely manner.

·         Maintains up to date knowledge of the cell and gene therapy fields/industries, technical and regulatory aspects as it relates to the position and the CMO competitive landscape.

·         Provide support and leadership to strategic initiatives in support of the biologics services business as needed.

·         Perform research and develop market analysis or presentations on the business unit or service areas as requested by management.

·         Performs special projects and other duties as required.

  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding  of  Good  Laboratory  Practices  and  Good  Manufacturing Practices
  • Other duties as assigned
  • May be required to assist in other departments

Job Requirements: Experience / Education

  • 7 or more years of relevant experience
  • Bachelors’ degree in Marketing/Business or Life Sciences required, Masters’ preferred or equivalent experience

Knowledge / Skills / Abilities:

 

  • Extensive knowledge of the CMO & biotech/biologics industries.
  • Demonstrated success at managing multiple opportunities and projects
  • Ability to work effectively as part of a team and to exhibit effective interpersonal
  • Ability to receive and comprehend and to effectively communicate detailed scientific and business information through verbal and written communication.
  • Understanding and  familiar  use  of  Microsoft  Office  products  such  as  Word,  Excel, Powerpoint and
  • Strong written and oral communication skills.
  • Outstanding organizational and time management
  • Demonstrated ability to work under pressure.
  • Excellent interpersonal
  • Ability to work effectively with customers and internal
  • Ability to use judgment as dictated by complexity of
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

 

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Job Title:                                          Regulatory Affairs Associate Director

Reports to (Title):                           V.P. of Operation

Location:                                          Shanghai

Exempt/Non-Exempt:                    Exempt

Direct Reports :                              No

Department:                                     RA

Cost Center:

EEO Job Category                         Professional

 

Job Summary: The Regulatory Affairs Associate Director is responsible for preparing on-time filing of high-quality regulatory submissions, regulatory and technical documentation to support and obtain regulatory approvals, post-approval maintenance of regulatory dossiers, and maintain both quality and regulatory compliance.  In addition, this position will interact with project teams and regulatory agencies in relation to submissions, compliance, and other relevant topics.

 

Essential Job Functions:

 

  • Participates in the development and implementation of the regulatory strategy: compiles information and data pertaining to regulatory and project requirements; assesses needs; identifies the project’s critical factors; presents decision-makers with options; applies
  • Assembles a regulatory file/dossier: coordinates acquisition of all applicable data; assessed data; drafts and submits the regulatory
  • Monitors product files in the developmental phase: updates data; reconciles requests from authorities based on scientific and ethical constraints; makes amendments/changes and submits them to
  • Conducts regulatory monitoring of approved products: assists and supports in-house teams; maintains files current; ensures regulatory compliance; evaluates the effects of an amendment/change; takes appropriate regulatory
  • Provides counselling to internal and external clients with regulatory issues: ensures regulatory monitoring; formulates a regulatory opinion; supports employees and the management team; represents the company; conveys information about regulatory matters and their
  • Communication and Interpersonal Skills: Ability to build relationships of trust and demonstrate professional
  • Preparation, Submission, and Follow-up of a Regulatory File
  • Properly documents all file
  • Diligently verifies that collected data comply with the regulations in
  • Conducts proper assessments in order to anticipate questions and critical
  • Clearly responds to questions from regulatory

 

  • Justifies position (legal, ethical, or scientific) when there are differences of opinion in connection with a request from regulatory
  • Regularly monitors commitments/obligations in response to regulatory requirements or
  • Provides operational support for Quality, Manufacturing and Testing activities as it relates to Regulatory and Compliance
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is
  • Normally receives minimal instructions on routine work and detailed instructions on new
  • Performs support functions for Quality Assurance
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Other duties as assigned

 

Job Requirements: Experience / Education

  • 5-7 years of relevant experience or equivalent
  • A university degree in science (bachelor’s, master’s, doctorate) biology, chemistry, biochemistry, or a related discipline e. regulatory affairs

Knowledge / Skills / Abilities:

  • Autonomy and
  • Ability to communicate effectively, negotiate, and
  • Ability to work on multiple projects at the same
  • Ability to keep tight deadlines and work under

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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.

 

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Job Title:                                          Senior Project Manager

Reports to (Title):                           Supervisor or higher

Location:                                          Wuxi or Shanghai

Exempt/Non-Exempt:                    Exempt

Direct Reports :                              No

Department:                                     Project Management Cost Center:

EEO Job Category                         Professional

 

Job Summary: Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical staff and business development staff. Advocates for the client within WuXi AppTec and with WuXi AppTec’s subcontractors. Represents WuXi AppTec’s best interests before clients.

Essential Job Functions:

  • Manages Medium Projects within functional reporting structure or business unit in addition to managing smaller
  • Manages Some Key accounts and Produces Metrics for Each Accounts Performance
  • Custom Quote and Proposal Development with Some Ownership and accountability for bringing Project to Fruition
  • Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical staff and business development
  • Keeps clients updated in a timely manner regarding progress of project, decision points, and events through teleconferences, e-mails, site visits or other suitable
  • Maintains project documentation - communications, schedules, sample submission paperwork, meeting minutes,
  • Informs internal resources of project updates / timely communications
  • Some Custom Quote and Proposal Development with assistance of Technical Team
  • Logs in Projects into OTS and maintains correct pricing as per the executed contract
  • Ensures that testing is performed as per executed contract and brings all scope changes to the attention of
  • Invoices Projects as per the executed contract
  • Normally receives minimal instructions on routine work and detailed instructions on new
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Other duties as assigned
  • May be required to assist in other departments

Job Requirements: Experience / Education

  • 5 +years of relevant experience or equivalent
  • Bachelors’ degree in Biological Sciences or equivalent experience

Knowledge / Skills / Abilities:

  • Understanding and Technical Knowledge of the Organization's Core Business to contribute to Overall Business Aims
  • Broad and Deep Understanding of Project Management Principles
  • At least 5 years of relevant Project Management
  • Training and  experience  in  Good  Laboratory  Practices,  Good  Manufacturing Practices and/or Good Tissue Practices
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • Must be able to work in an office environment with minimal noise
  • Must be able to work in Lab setting with Biohazards /various Chemicals
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift 10 lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull 10 lbs routinely/ often / occasionally
  • Clarity of Vision
  • Ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions
  • Ability to climb Ladders / Stairs / Scaffolding
  • Ability to work in variable temperatures high to freezing
  • Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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.

 

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Job Title:             Senior Director of Gene Therapy Vector cGMP Manufacturing Operations

Department:        Gene Therapy Vector

Reports To:            GM

Location:                Wuxi Huishan district

 

JOB SUMMARY

Responsible for the daily operations in Gene Therapy Vector manufacturing and facilities. Knowledge of cell and gene therapy manufacturing and support systems is essential. Demonstrated managerial skills and a strong working knowledge of the regulatory compliance.Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues. Prepares validation protocols, SOPs, material specifications and develops new client master batch records. Manages Gene Vector manufacturing operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the U.S. and China GMP regulations.

 

POSITION RESPONSIBILITIES:

  • Responsible for representing Manufacturing in the build-out, commissioning and validation of the GMP Gene therapy vector facility
  • Determining staff and equipment resources.
  • Identification and development of Standard Operating Procedures (SOPs), Master Batch Records, and Product Specification
  • Staffing and training of the assigned Manufacturing group to be competent in current Good Manufacturing Practices (cGMP).
  • Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, and Materials Management As needed, interaction will be required with material/equipment vendors and clients.
  • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's
  • Recommends hire/transfer/promotion/discharge and salary changes and acts on employee
  • Conducts employee performance appraisals in a timely and objective
  • Maintains production schedule to meet customer and business
  • Provides accurate production forecasting methods with continuous improvement through capacity optimization and cost reduction
  • Implements and maintains personnel policies, procedures and production control systems.
  • Ensures cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality

Position Qualifications:

  • Minimum of 8 years supervisory experience and 10 years’ experience in biologics/Gene Vector manufacturing is required.
  • Direct experience in gene/cell therapy manufacturing
  • Has a thorough understanding of cGMP requirements
  • Experienced in commercial manufacturing requirements for biological or cell or gene therapy
  • Excellent communication skills, both oral and
  • Demonstrated leadership
  • Ability to evaluate technical data and write technical