SUMMARY
This leading global pharmaceutical company is looking for a strong Formulation Scientist to join their R&D team in support of one of the fastest growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have strong hands-on experience with solid oral dosage forms, ANDA filing, & scale-up from lab scale to commercial manufacturing batches in a cGMP environment.
RESPONSIBILITIES
- Lead formulation development activities as the SME for novel oral solid products
- Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE).
- Conduct GMP stability studies & analysis using the relevant industry-standard modeling tools to ensure purity and shelf life of products throughout scale-up processes.
- Manage tech transfers to CRO/CDMO/CMO's in collaboration with project management teams in accordance with project timelines & deliverables.
- Participate in cross functional meetings and provide input on strategy implementation for various projects.
- Author & review relevant technical documents/SOP's & FDA submissions
- Mentor junior staff on formulation techniques
QUALIFICATIONS
- Ph.D. in Pharmaceutical Sciences (Or equivalent/relevant degree) with 1-2 years of drug product/formulation experience in the pharma industry OR M.S. + 4-6 years
- Strong experience with tablets, capsules, solid orals and scaling up to manufacturing-scale is a MUST.
- experience with ANDA filing is highly preferred
- Strong communication skills (written & verbal)
- Prior experience with tech-transfers or management of CRO's/CMO's is a PLUS
- Experience with additional dosage forms (nasal, injectables, topical, solutions, etc.) is a major plus!
ADDITIONAL
- Fully on-site position
- Relocation & Sponsorship available
- 10% Annual Bonus + Strong Benefits Package
