Process Development MSAT Engineering Scientist
Semma Therapeutics
Job Description
General Summary:
The successful candidate will be responsible for MSAT activities for cell therapy products for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT). He / she will provide cross-functional support in technology development and transfer from Development to Clinical Manufacturing including operations at various CDMOs. The candidate will also plan and implement continuous improvement initiatives.
This full-time position will be based in Boston, MA
Key Duties and Responsibilities:
- Develop strategy for process technology transfer and process validation.
- Support Technology transfer efforts to CDMOs, including but not limited to, initiating MBRs, forms related to MFG process, and protocols/reports related to Tech Transfer milestones as well as training operators at early stage, and acting as SME for process.
- Responsible for material assessments and material substitutions; execution of process changes and leading change controls; assessments of post TT changes on materials, equipment, room configuration.
- Provide technical oversight for GMP production.
- Design and guide process optimization.
- Author and review technical reports, regulatory filings, process and material risk assessment.
- Troubleshoot and resolve process challenges through the application of acquired technical experience process analytics.
Knowledge and Skills:
- Hands on experience with tech transfer to CDMOs and experience with process validation.
- Experience with cell-based therapies.
- Regulatory filing experience.
- Experience leading cross-functional teams.
- Excellent communication skills to exchange complex technical/scientific with cross- functional teams and CDMOs.
- Proven experience with Process Development, Process Technology Transfer, Technical Operations, and Lifecycle Management.
- Knowledge of Design Control and Risk Management.
- A strong understanding of statistical analyses, technical writing and presentation skills.
Education and Experience:
· Bachelor's degree and 5+ years of experience or a Master's degree and 3+ years of experience or a PhD and 1+ years of experience, or the equivalent combination of education and experience.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.