GLOBAL REGULATORY CMC BIOLOGICS/CELL THERAPY MANAGER
A globally renowned biopharmaceutical corporation located in Summit, NJ is seeking to hire a Global Regulatory CMC Biologics Manager for a 12-month contract.
The Regulatory CMC Biologics/Cell Therapy Manager will be responsible for: 1) supporting the Regulatory CMC Biologics & Cell Therapy group in the preparation of submissions. Submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications. Location: Summit, New Jersey
Duration: 12-month contract
Compensation: $35-40 per hour
* Must have 5-7 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Biologic/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
* Education: Bachelor Degree required; Master's Degree or PhD preferred
* Experience with Biologic CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
* Experience with CMC regulations for biological compounds
* Experience with Gene/Cell/CAR T Cell therapy CMC regulations
* Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
Sthree US is acting as an Employment Business in relation to this vacancy.