Semma Therapeutics, a biotechnology company focused on developing a pluripotent stem cell-based cell therapy for Type 1 diabetes, is seeking an outstanding Quality Control Associate to join its growing team. Semma is establishing a cGMP compliant manufacturing facility for the preparation of ES-derived pancreatic Islets for use in Phase I/II clinical investigations. This position will perform QC tests for pre-clinical and clinical material from specific manufacturing steps associated with ES-derived pancreatic Islets production, from cell bank thaw through fill/finish. QC testing will include stability tests for cell banks and final product, in-process manufacturing tests and final product lot release tests. The candidate will be expected to assume additional QC testing responsibilities associated with specific projects (e.g. cold chain custody qualification, in-use stability testing, etc). The position will be located in Cambridge/Boston, MA.
Key Responsibilities Include:
- Perform immunocytochemistry, flow cytometry assays and cell counts and viability on drug substance for product release
- Perform qPCR testing for a variety of test articles.
- Qualify/validate QC assays as needed. Write protocols and reports for qualifications/validations.
- Perform IOP/Q of quality control equipment.
- Maintain detailed records of experiments and outcomes in accordance with Semma Therapeutics quality assurance expectations.
- Interpret and analyze results using statistical software packages (e.g. JMP) as appropriate. Make recommendations on QC related issues to the QC team and the Executive Director of Quality.
- Work with QC co-workers and health and safety department to ensure lab complies with regulations and all required trainings.
- Participate in multidisciplinary teams across Semma Operations as needed.
- Contribute substantively to the preparation of documentation for regulatory filings, especially in the CMC section. May contribute to publication of findings and present ongoing work and findings to colleagues at industry conferences.
- Train staff or collaborators in accordance with Semma Therapeutics training guidelines and quality assurance expectations as needed, including oversight and instruction on techniques, as well as consultation on project work.
- Perform general lab maintenance as needed; maintain lab stock, manage the QC reagent inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory
- Bachelor's degree in related scientific field and three year’s of Quality Control experience in a pharmaceutical or biotechnology cGMP setting, or Master's degree with a minimum of one year’s experience.
- At least one year’s experience in a QC lab with each of the following methodologies: Immunocytochemistry/Immunofluorescence-particularly within a high content setting (96-well, 24-well plates) highly desired; flow cytometry; Molecular Devices ImageXpress Micro 4
- Experience performing qPCR as well as experience working with a mycoplasma detection software package designed for real-time PCR is a plus
- Strong collaboration, communication and problem- solving and customer service skills essential
- Ability to adapt in a fast-paced environment
- Must be authorized to legally work in the United States
- ELISA experience is a plus
- Experience with BacT Alert or comparable sterility test is a plus
- Experience with Endosafe is a plus
- Experience qualifying/validating QC assays is a plus
- Strong analytical skills and excellent
- Ability to work under deadlines with general guidance is
- Excellent organizational skills and demonstrated ability to accurately complete detailed
Job Type: Full-time