Principal Scientist, MSAT
Semma Therapeutics
Job Description
General Summary:
Vertex MSAT team is seeking a Principal Scientist to join a growing team in support of commercial Cell and Gene Therapy programs. This position will be responsible for providing technical support in alignment with defined program priorities linked to cell culture, technology transfer, validation, and investigation.
Key Duties and Responsibilities:
Support late stage/commercial technical agenda including continuous improvement, process optimization, tech transfer, and validation.
Manage commercial lifecycle management lab efforts.
Plan, collect, analyze, and report data for ongoing and completed runs.
Author technical protocols, reports, and other GMP supporting documents.
Contribute to developing technical solutions to enable program and company goals.
Knowledge and Skills:
Significant cell culture lab experience with various platforms and technologies.
Experience with designing and executing studies to support product in cGMP manufacturing.
Experience with process characterization and process control strategy preferred.
Knowledge of technology transfer, process validation, process monitoring and commercial lifecycle management.
Experience with cGMP regulations/guidance and experience with regulatory agency inspections preferred.
Experience with developing CMC content and knowledgeable on regulatory guidance and trends preferred.
Ability to communicate ideas clearly and confidently.
Familiarity working in a matrix environment with strong networking and influencing skills.
Proven problem-solving and analytical capabilities that drive value and insights.
Education and Experience:
PhD, MS, or BS in relevant science or engineering discipline.
PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience
#LI-LN1
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.