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CMC Analytical Development Scientist (cGMP – Pharmaceutical – Gene Therapy) JD820707

JD820707

DPS is looking for a proven Analytical Development resource to support a biopharmaceutical client in the Boston, MA area. The ideal candidate be responsible for supporting the analytical method development and coordinating analytical vendors for the company’s gene therapy programs. Please be aware that this role may also require occasional travel (up to 10% can be expected).

Category:
Control Quality
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
15/07/2020
Days Remaining:
4
Employment Type:
Full-time
Education Level Req.:
Bachelors

CMC Analytical Development Scientist (cGMP – Pharmaceutical – Gene Therapy)        JD820707

Boston, MA area

 

DPS is looking for a proven Analytical Development resource to support a biopharmaceutical client in the Boston, MA area. The ideal candidate be responsible for supporting the analytical method development and coordinating analytical vendors for the company’s gene therapy programs.

 

Please be aware that this role may also require occasional travel (up to 10% can be expected).

 

Responsibilities:

 

  • Manage and organiz996221.242122e CTL/CDMO activities and schedules associated with gene therapy analytical development and testing.
  • Review analytical plans, method design and test method data generated by CTL/CMOs and where applicable write summary reports.
  • Perform data analysis and trending for analytical test methods
  • Design and plan analytical technical and operational details with CTL/CMOs to support analytical development and technology transfer for vector gene therapy programs
  • Inform and support execution of CMC analytical methods and testing decisions, including component and raw material specifications, drug substance and drug product specifications, DS and DP in-process specifications, virus and cell bank testing, analytical methods, product characteriz996221.242122ations, comparability studies, stability programs, release testing procedures, SOPs and other controls for company products.
  • Facilitate and coordinate operational logistics associated with analytical samples, analytical raw materials, and shipping as needed.
  • Assist in reviewing analytical content of Quality Systems documents (testing data, batch records, SOPs, deviations, validation reports, etc.)

 

Education and Requirements:

 

  • Master’s/Bachelor’s degree in a biology or biochemistry field.
  • 3+ years in the biotechnology industry.
  • Experience with gene/cell therapy and working with CTL/CMOs is strongly preferred.
  • Knowledge of analytical development and analytical testing, cell and immune based assays, product characteriz996221.242122ation, cGMP, and drug development.
  • Knowledge of viral based biologics, statistics, and troubleshooting processes.
  • Experience in coordinating with internal and external stakeholders, and CTL/CDMOs used for process and analytical development and GMP manufacturing.
  • Ability to work well with cross-functional teams or independently in a dynamic and highly collaborative environment.
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