Clinical Supply Chain Manager
Semma Therapeutics
Job Description
The Clinical Supply Manager is responsible for forecasting, packaging, labeling and distribution of investigational medicinal product to support Vertex clinical studies. This person delivers on independent activities and acts as the primary Supply Chain contact on working teams and with key contract manufacturing/logistics suppliers. This is a Boston, based hybrid position (3 days week onsite).
Key Responsibilities:
- Ownership of Clinical Supply Chain activities including planning, labeling, packaging and distribution of Investigational Medicinal Product for multiple projects.
- Acts as primary point of contact with contract manufacturing partners.
- Forecasts supply needs in conjunction with Clinical and CMC colleagues.
- Interacts with Finance to develop budgets and manage costs for clinical supply activities.
- Supports the Supply Chain team’s development of global supply and procurement strategies including vendor selection.
- Utilizes appropriate software and IT systems to effectively manage key project activities.
Displays proven effectiveness in managing customer expectations and influencing others. - Forecasting program level and study level needs. Working with CMC team to design packaging and stability needs.
- Work with cross functional team including Clinical Operations and CMC to develop program wide supply plan.
- Medical Device packaging and labeling
Education and Experience:
- B.S. and 4+ years of experience working in a Pharmaceutical Environment, 1-2 years of which are in a Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
- Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP).
- Knowledge of Interactive Voice/Web response systems for use in clinical studies.
- Experience with Medical Devices in Clinical Trials
- Clinical Supply management experience using contract manufacturing companies strongly preferred.
#LI-KO1
#LI-Hybrid
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.