Quality Control Stability Manager Merrimack Pharmaceuticals
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
The Quality Control Stability Manager will lead Merrimack?s stability program to support clinical, pre-commercial, and commercial in-house drug production. Our Stability program spans both protein biologic and liposomal pharmaceutical drug substances and products. This position will be a key member of the Merrimack's drug development and commercialization efforts and will work closely with internal groups such as formulations, clinical, regulatory affairs, and QC/QA departments, as well as external contract test laboratories.
Maintain and optimize stability programs for both liposomal and protein drugs following applicable ICH/FDA/EMA guidances
Author and implement appropriate stability policies and procedures
Author stability protocols, interim and final stability reports
Ensure all stability samples are maintained in appropriately qualified, controlled and monitored storage chambers
Ensure that all stability testing is completed according to the approved protocol within established time periods
Develop appropriate statistical analysis and interpretation to support shelf life determination, specification setting, and clinical supply expiration extensions
Develop and implement tools and procedures to facilitate information flow to regulatory, clinical, and supply chain customers
Author applicable CMC sections for INDs, IMPDs, NDAs, BLA?s, and MAA?s
Assist in LIMS implementation for Stability
Manage 1-2 stability personnel and interact with QC scientists for data interpretation.
Represent stability program during audits and regulatory agency inspections
B.S. or M.S. in biochemistry and 7+ years of experience in pharma/biotech QC
2-4 years managing stability programs; 2-4 years of supervisory experience
Excellent team skills and outstanding organization and presentation skills
Reliable and motivated with strong interpersonal communication skills (written and verbal) and the ability to thrive in a team environment
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139