GMP Support / Sr. Scientist / Team Lead
Direct Hire in Lexington, MA
Local Candidates Preferred
The Team Lead, Sr. Scientist for GMP Support, will be part of the Product Analytical Development (PAD) group supporting the late stage development of AAV-based gene therapy products.
The Team Lead will focus on assay technical support and troubleshooting, and act as the first point of contact for GMP support (QC, QA & regulatory) for late stage activities.
Responsibilities:
- Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
- Providing analytical support to Process Development (PD) activities by ensuring consistent and timely execution of standardized product characterization assays, including data review, storage, and trending.
- Integrating new program products into Client analytical platforms, to ensure timely progress of technology transfers and regulatory submissions.
- Providing late stage analytical development support to Quality and Regulatory efforts, during investigations, risk assessment, regulatory filings and validation activities, to ensure the maintenance and continuous improvement of the analytical packages for each program, in accordance with appropriate legislation and following the highest quality standards.
- Lead a team of scientists and technicians focused on the GMP support of late stage analytical methods for gene therapy applications, including assay troubleshooting, QC team validation issues, investigations, laboratory testing, and documentation
- Drive alignment of platform assays across AD sites with QC assays during revisions and updates of platforms driven within QC or AD
- Ensure on time, complete delivery of GMP support activities according to project specific needs, and according to platform renovation plans.
Qualifications & Skills
- A Life Sciences Ph.D. + 6 years' or M.S. + 10 years' relevant post-graduate experience, including intensive experience in biotech industry, is required
- At least 2 years' experience leading scientists and/or technicians as direct reports
- Broad hands-on experience in analytical development of biologics is required, experience in viral vaccines or gene therapy is a plus
- Experience with method transfer to GMP labs, assay troubleshooting and process/product investigations are required
- Experience of assay characterization, qualification, and validation with EMA/FDA regulations, ICH guidelines, GMP and quality systems is preferred
- Strong knowledge and understanding of cell based (potency or infectivity), molecular (RT-PCR, qPCR or ddPCR, NGS a plus), and Biochemistry (e.g. HPLC, ELISA) assays.
- Ability to adapt to, communicate, and support re-prioritization of activities and goals in a fast-paced environment
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Company:YohLocation:Lexington - Massachusetts - United StatesJob Types:Full TimePost Date:November 7, 2021Valid Through:December 6, 2021