Potency Assay Scientist
Potency Assay Scientist
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Job Description
We are seeking a highly skilled and motivated individual to join our team in a critical role supporting the development optimization and validation of analytical methods:
Primary Responsibilities:
- Optimize technical transfer qualification and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
- Execution of complex GMP release and stability assays including cellbased functional assays flow cytometry methods ddPCR ELISA and NGS assays.
- Author and review SOPs and technical reports.
- Acting as an SME resource to external partners
- Work with crossfunctional groups within the client environment to participate in various aspects of method development transfer process and product characterization comparability and investigations.
- Analyze track and trend data to monitor analytical assays and ensure consistency in assay performance.
Qualifications :
- Bachelors degree with 36 years of experience
- Masters degree with 13 years of experience
- Strong background in cell culture and experience working with cell lines and primary human cells.
- Experience with functional or potency assay transfer and execution in a GMP laboratory.
- Broad experience with molecular biology cellular and immunoassay techniques including transfections/transductions ddPCR/qPCR flow cytometry ELISA and NGS.
- Experience using data analysis software including JMP is preferred
- Knowledge of ICH/USP guidelines.
- Proven track record of functional and potency assay qualification and validation.
- Team player with excellent oral and written communication skills.
- Independently motivated detailoriented and excellent problemsolving abilities.
Additional Information :
The position is fulltime MondayFriday from 8am5pm. Candidates living within a commutable distance of Cambridge MA and the surrounding areas are encouraged to apply.
- Excellent fulltime benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients site dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.
We infuse our 55year track record of scientific and laboratory operations expertise as well as HR and great place to work best practices to recruit hire train and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories please explore our website
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
