Multiple positions, 石药集团

 

Senior Director, Formulation Development

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for two Project Discipline Leaders (Pharmaceutical Analysis). The requirements for this position are as follows:

Requirements:

  • Major in Pharmacy
  • Doctoral degree
  • The graduation task should relate to quality study in research and development (R&D) of drug product; The job candidate should be the key person in charge of R&D in manufacture license application during the transition course from R&D to production
  • Minimum of 3 years of R&D experience in large new drug R&D company
  • Minimum of 3 years of experience in Pharmacy, participating in at least five projects, acting as project discipline leader in Pharmacy in three or more R&D projects, among which, in at least one project covering the whole course from pharmacy application, supplementary documents submission, manufacture license application to CFDA till manufacture approval.
  • Knowledge of regulatory submission procedures, ability of developing study protocol independently and guiding the inexperienced staff in research efforts, experience of writing submission dossiers
  • Excellent concise communication skills, ability to read pharmacopeia and literature references in English skillfully

 

  • Position in Organization Structure: Senior Director
  • Pay and Benefits: Competitive with current industry standards

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

 

 

Senior Director, Pharmaceutical Analysis

 

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for two Project Discipline Leaders (Pharmaceutical Analysis). The requirements for this position are as follows:

Requirements:

  • Major in Pharmaceutical Analysis
  • Doctoral degree
  • The graduation task should relate to quality study in research and development (R&D) of drug product; The job candidate should be the key person in charge of R&D in manufacture license application during the transition course from R&D to production
  • Minimum of 3 years of R&D experience in large new drug R&D company
  • Minimum of 3 years of experience in pharmaceutical analysis, participating in at least five projects, acting as project discipline leader in pharmaceutical analysis in three or more R&D projects, among which, in at least one project covering the whole course from pharmaceutical analysis, supplementary documents submission, manufacture license application to CFDA till manufacture approv.
  • Knowledge of regulatory submission procedures, ability of developing study protocol independently and guiding the inexperienced staff in research efforts, experience of writing submission dossiers
  • Excellent concise communication skills, ability to read pharmacopeia and literature references in English skillfully

 

  • Position in Organization Structure: Senior Director
  • Pay and Benefits: Competitive with current industry standards

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

 

 Senior Director, Project Management

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for a Project and Information Department Manager or Director responsible for the screening, evaluation, demonstration and technical cooperation of foreign project.

 

Duties/Responsibilities: Support the work of Senior Director of the Project Development Department for the work of researchers

Requirements:

  • Master’s degree or higher in clinical pharmacology or clinical medicine
  • Engaged in more than three years of medical research and project proposal set-up. In addition, at least two of these projects have been submitted to FDA and have been in clinical trials
  • Familiar with the process of drug development and the current international R & D development of new drugs. Familiar with the process of drug application for FDA and CFDA. Capable of using various office-software skillfully. Proficiency in both spoken English and pharmaceutical/medical English. Certificate of CET6 or higher English level is required. Professional in the Chinese and English translation of clinical pharmacological literature
  • Brief and clear communication in both Chinese and English
  • Priority to those with overseas study experience, those with work experience in multi-national corporation, or those responsible for strategic planning of new drug R & D in mega domestic pharmaceutical enterprise

 

  • Position in Organization Structure: Senior Director
  • Pay and Benefits: Competitive with current industry standards

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

 

Director, Computer Aided Drug Design

 

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for a Computer Aided Drug Design Manager or Director depending on experience to develop original new drugs. As a full time, employee, the CADD person will be responsible for, but not limited to, the following activities:

Duties/Responsibilities:

  • Develop design strategies for originalnew drugs
  • Provide regulatory guidance for pharmacy, pharmacology, pharmacokinetics, toxicology and other related sections
  • Organize preclinical registration materials
  • Oversee IND submission in China and other countries

Requirements:

  • Doctoral degree in medicinal chemistry or computational chemistry
  • Minimum of 5 years of new drug research and development experience in US or other countries
  • A proven track record for new drug discovery and preclinical development within quality expectations
  • Master medicinal chemistry and drug discovery skills
  • Knowledge of preclinical research and drug registration guidelines and regulatory requirements
  • Knowledge of pharmacy, pharmacology, pharmacokinetics, toxicology and other related sections
  • Excellent communication and organizational skills with problem solving skills
  • Ability to handle a high volume of tasks within a given timeline
  • Ability to work extra hours and/or on weekends during critical situations
  • Ability to maintain a high level of accuracy and attention to detail
  • Position in Organization Structure: Institute Manager/Director
  • Pay and Benefits: Competitive with current industry standards

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

Senior Director, Pharmacokinetics

 

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for two pharmacokinetic project leaders responsible for the R & D of TK and PK projects.

 

Duties/Responsibilities:

Support the work of Senior Director of the pharmacology, pharmacokinetic and pharmacodynamic department.

 

Fully responsible for the R & D of TK and PK projects.

Requirements:

  • Doctoral degree or higher in pharmacokinetics field is required
  • Engaged in three to five years of experience in pharmacokinetic research on new drugs. In addition, independently committed to at least 3 research projects as the project leader.
  • Familiar with the analytic methods such as ELISA or LC-MS/MS. Capable of formulating experimental program and protocol independently. Proficiency in data processing and analytical methods. Research experience in pre-clinical or clinical pharmacokinetics is required.
  • Brief and clear communication in both Chinese and English.
  • Work experience in mega domestic pharmaceutical enterprise is required.
  • Proficiency in both spoken English and pharmaceutical/medical English.

 

  • Position in Organization Structure: Project Leader
  • Pay and Benefits: Competitive with current industry standards

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

 

Biologics CMC Head

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for a Biologics CMC Head. As a full time employee, the Biologics CMC Head will be responsible for, but not limited to, the following activities:

Duties/Responsibilities:

  1. Responsible for establishing and organizing the technical platform of biotechnology drugs CMC, such as the construction of stable cell lines for manufacturing, the establishment of pilot cell culture technology and optimization, the establishment of purification process to pilot grade protein and optimization, the study on preparation technology and stability of preparations, the establishment of quality standards to protein drugs and study on the quality of protein drugs.
  2. Responsible for establishing a research team, based on the existing R&D team, that has a reasonable construction, integrated field of knowledge, and rich experience on biotechnology drugs CMC.
  3. Responsible for establishing a biotechnology drugs CMC research and training system, so that new employees can improve their research and development skills based on this system as soon as possible; meanwhile, help the company improve the biotechnology research level.

Requirements:

  1. Doctoral degree in relevant major.
  2. More than 10 years’ work experience in R & D and management within an international company. Served as the project leader or department head in the company.
  3. Past work experience in charge of more than one biotechnology drugs program (antibody projects priority). Obtain the clinical research permission in at least one field of study.
  4. Familiar with the technical requirements of biotechnology drugs CMC before the clinical trial phase. Be able to provide professional assessment and recommendations beyond his or her field of study.

Location: Shijiazhuang, Hebei Province, China.

United States,

The required work time in China should not be less than 80% of total.

Pay and Benefits

The Pharmaceutical Group provides attractive remuneration and benefits in the industry, including paid leave, medical insurance (medical insurance, dental insurance, vision insurance, covers spouse and children), life insurance, unemployment insurance, and 401K program.

CSPC will be responsible for relocation, such as rent, transportation, children’s education, etc.

 

Please contact Qingxi Wang: 609-356-0210 Ext 101; [email protected]

 

 

 

 

 

 

 

 

Regulatory Affair Manager/Director/Executive Director

 

CSPC Pharmaceutical Group Ltd (“CSPC”) is a premier Chinese Pharmaceutical company listed in Hong Kong Stock Exchange. Driven by CNS and oncology-dominated innovative product portfolio and international growth strategy, we are looking for a Regulatory Affair Manager, Director or Executive Director depending on experience to prepare regulatory submission in US and other countries. As a full time employee, the RA person will be responsible for, but not limited to, the following activities:

Duties/Responsibilities:

  • Develop regulatory strategies for IND, NDA and aNDA submission in US and other countries
  • Oversee IND submission in US and other countries
  • Provide regulatory guidance for clinical research and commercial development
  • Ensure regulatory submission is compliant with GCP guidelines and internal SOPs
  • Maintain current knowledge of regulatory requirements in US and other countries
  • Develops working relationships with consultants in various countries
  • Identify issues and negotiate and implement solutions where possible
  • Communicate status reports to upper management and leadership of contributing functions

Requirements:

  • Bachelor’s degree or higher in science or health-related field required
  • Minimum of 15 years of regulatory affair experience in US and other countries.
  • A proven track record for delivering IND, NDA and aNDA submission within quality expectations
  • Knowledge of GCP, ICH guidelines and US regulatory requirements
  • Excellent English communication and organizational skills with problem solving skills
  • Ability to handle a high volume of tasks within a given timeline
  • Ability to work extra hours and/or on weekends during critical situations
  • Ability to maintain a high level of accuracy and attention to detail

Location:                                     Princeton, NJ

Working time:                40 hours per week

Pay and Benefits:           Comparable to current industry standards with benefits

 

Please contact Simon Li: 609-3560210 ext103 [email protected] or [email protected]

2017-04-24T15:51:16+00:00