Location: Cambridge, MA
A fast-growing targeted therapy oncology business based in Cambridge, Massachusetts requires a Drug Product Development & Manufacturing to lead formulation development and manufacturing of clinical and commercial drug product for all programs. The successful candidate will manage operations at external manufacturing sites, helping the oncology platform to bring innovative new therapies to patients. Other leadership responsibilities include assuring adherence to phase-appropriate regulatory and quality requirements, and representation of the drug product function on cross-functional teams.
What You’ll Do:
Leads the development and manufacturing of phase-appropriate dosage forms to supply clinical study drug and commercial supplies.
Contributes top-tier expertise to develop immediate release, modified release, and pediatric oral formulations for new small-molecule chemical entities.
Works with external manufacturers to develop and scale processes, including formulating and implementing strategies for product registration and validation.
Supervises activities at contract manufacturers, provides plant-floor support, and manages consultants as needed to ensure effective execution of manufacturing activities and timely delivery of clinical trial materials and commercial drug product.
Initiates drug product project activities in response to overall program goals and timelines, requests proposals from prospective manufacturers, contributes to vendor selection, and manages the successful execution of plans consistent with operating budget and program objectives.
Troubleshoots manufacturing nonconformances, conducts systematic process risk assessments, and identifies critical process parameters to ensure robust performance during late-stage development and commercial production.
Collaborates with Analytical Development, Regulatory Affairs, and Quality Assurance partners to plan and execute on process registration and validation activities that will ensure marketing application acceptance and PAI readiness.
Authors development reports, critically reviews batch documentation, and contributes to the preparation of the drug product sections of regulatory submissions.
Effectively integrates drug product activities with those of the Analytical Development and Drug Substance functions, as well as Quality Assurance and Regulatory Affairs.
For more information on this exciting role in a truly dynamic biotech please forward an up to date resume to email@example.com
Excellent salary, bonus and stock package
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