Duration: 6-12 months, full time
As Drug Substance (DS) Technical Steward, you will be assigned a portfolio of late-stage or commercial products, with overall responsibility of providing hands-on technical leadership during the technology transfer phase, process qualification, and regulatory submissions.
In this capacity, you will work closely with Biopharmaceutical Process Development (BPD), manufacturing sites (internal or external), other GTO functions, and Quality organizations.
- Lead technology transfer of commercial drug substance processes (upstream and downstream) into external manufacturing sites (CMO’s).
- Author and approve process descriptions and facility fit assessments for these manufacturing sites.
- Review and approve tech transfer and manufacturing documentation such as risk assessments, gap analyses, SOPs, and batch records.
- Develop predictive tools to map cell culture and purification processes into commercial facilities.
- You will also serve as the Operations Drug Substance representative on the Product CMC teams and provide technical expertise for ongoing commercial manufacturing and managing post-approval changes.
- We are looking for candidates with a deep understanding of biologics (Mammalian cell culture) manufacturing, quality, and process development.
- CMO oversight need someone with experience in GMP cell culture process dev/ MFG/Quality with ~10 years industry experience, and prior experience working on drug substance process tech transfers (ideally in a lead role/ and global tech transfers)
- Technology Transfer
- Process Development
- Process Qualification
- Education: B.S. Degree required at Minimum. 10+ years of experience is required.
JOB ID# 226570