Job description
Job Description
Principal Scientist, MSAT – Commercial Manufacturing and Supply Chain, Vertex Pharmaceuticals (Boston)
Vertex MSAT team is seeking a Principal Scientist to join a growing team in support of commercial Cell and Gene Therapy programs. Reporting to the Director MSAT - Process, this position will serve as a technical lead for technology transfer, validation, and lifecycle management initiatives across the network.
Key Responsibilities:
- Technical lead within a cross-functional team executing tech transfer and validations in the commercial CMO network.
- Champion change management initiatives ensuring stakeholder consensus and alignment with business objectives.
- Identify and/or lead compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
- Provide guidance and applicable content for CMC regulatory submissions and ensure technical compliance with established conditions.
- Provide SME support for health authority inspections and post-approval CMC changes.
Minimal Requirements:
- Bachelor's Degree in science, engineering, or related discipline is required.
- Typically requires 8 years of experience in biopharmaceutical industry with increasing responsibility, or the equivalent combination of education and experience.
- Extensive experience with technical support of commercial products and CGMP manufacturing.
- Extensive experience with commercial lifecycle management activities: technology transfer, process validation and optimization.
- Experience with cell and gene therapies preferred.
- Knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections desirable.
- Direct experience working with contract manufacturing (CDMO) and/or technical service partners.
- Experience with developing CMC content, post-approval changes, and knowledgeable on regulatory guidance and trends.
- Proven experience with leading complex projects with cross-functional teams.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.
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