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Sr. Scientist, Analytical Sciences & Technology
Company | Bristol Myers Squibb |
Address | Devens, MA, United States |
Employment type | PART_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-06-19 |
Posted at | 11 months ago |
Working with Us
- Function as the molecular biology analytical expert in support of QC lab investigations. This encompasses leading technical investigations, identifying root cause and providing corrective and preventive actions, including method remediation.
- Some sample management might be required.
- Implement method lifecycle and method maintenance programs to support molecular biology methods in support of viral vector and cell therapy drug products.
- Responsible for authoring relevant analytical sections of submissions, responding to health authority questions. Functions as the method validation and method transfer expert during inspections.
- Responsible for the stewardship of molecular biology methods in the Quality organization.
- Function as the technical expert for transfer of commercial molecular biology methods and method validation in compliance with global regulatory requirements.
- Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives. Represent the function on cross-functional project teams.
- BS/MS in relevant scientific discipline and 10+ years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization. Experience in cellular therapies is highly desired.
- Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.
- Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.
- Strong scientific background and expertise with various molecular biology methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
- Experience in analytical method lifecycle, including method transfer, validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization.
- Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.
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