Analytical Science and Technology Principal Scientist
Semma Therapeutics
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General Summary:
The Principal Scientist, Analytical Science and Technology (ASAT), plays a critical role in the Commercial Manufacturing & Supply Chain team. S/He is responsible for providing analytical expertise to support manufacturing and quality control of commercial Cell and Gene therapy (CGT) products. S/He is also responsible for leading the analytical method lifecycle management (ALCM) activities.
Key Responsibilities:
- Lead ALCM projects including late stage and post-marketing approve analytical activities such as method validation and method transfer.
- Be accountable for the success of ALCM projects/activities and ensure on-time deliverables to meet program commitments
- Be a key contributor to analytical method continuous improvement and lifecycle management
- Participate in troubleshooting and the investigations during routine manufacturing and quality control operations
- Be primary SME for analytical testing and method performance executed at CDMOs and contract testing labs
- Own ALCM related change controls
- Support program collaborations with internal Vertex functions including Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, and Quality teams
- Support regulatory submissions and responses to health agency inquiries
Knowledge and Skills:
- Demonstrated expertise in analytical method development, qualification, validation and transfer for biologics and/or cell gene therapy drug products
- Working experience in late stage or commercial environment with a good understanding of GMP operation is required
- Experience and knowledge of regulatory requirements and ICH guidance related to ALCM activities is required
- Hands-on experience with in-vitro cell-based functional/potency assays and flowcytometry for CGT products is highly desirable
- Experience in managing contract testing sites (CTO/CDMO) is recommended
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and efficiency.
- Sufficient technical writing skill is a must.
- Experience of using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concept are preferred.
- Excellent communication skills with the proven ability to work with internal and external partners is a plus
Education and Experience
- Bachelor’s degree or above in Science or related discipline
- 10 years of experience in the pharmaceutical/biopharmaceutical industry with increasing project and management responsibility, or the equivalent combination of education and experience
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select
On-Site: work five days per week on-site with ad hoc flexibility
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.
This job is no longer accepting applications
See open jobs at Semma Therapeutics.See open jobs similar to "Analytical Science and Technology Principal Scientist " F-Prime Capital Partners.