Principal Scientist, Oral Product Development
Bristol Myers Squibb
5 hours ago
On-site
New Brunswick, NJ
Clinical Research and Development
Responsibilities:
- Execute drug product formulation/process development, strategies, and control strategies for small-molecule oral drug products.
- Collaborate with Drug Product, Analytical, API, Quality, and Regulatory to support CMC activities and drug application submissions/approvals.
- Develop oral formulations for clinical studies and commercialization.
- Lead formulation and process development to enhance oral bioavailability, stability, and processability.
- Support preparation of CMC regulatory documents.
- Prepare technical reports, batch records, SOPs, publications, and oral presentations.
- Collaborate cross-functionally to optimize formulations and enable technology transfer to CMOs/other sites.
- Support departmental initiatives; maintain safety/regulatory/compliance standards; develop/coach/mentor others.
Qualifications/Experience:
- BS in Pharmaceutical Science, Chemical Engineering, or related field with 9–12 years experience; MS with 6–9 years; or Ph.D. with 4–6 years.
- Hands-on formulation development and pharmaceutical processing experience.
- Knowledge of drug substance/excipients, unit operations (blending, milling, sieving, granulation, tableting, encapsulation, coating, spray drying), CQAs/quality attributes, statistics, risk assessment, and cGMP.
- Experience building CMC dossiers (author/reviewer) and basic regulatory knowledge.
- Problem-solving/troubleshooting, experimental design/execution, independent work, leadership/training, strong communication and interpersonal skills.
Benefits (if eligible): Health (medical/pharmacy/dental/vision), wellbeing programs (e.g., EAP), financial protection (401(k), disability, life/accident, etc.), and paid time off (incl. flexible time off/paid vacation and national holidays).
- Execute drug product formulation/process development, strategies, and control strategies for small-molecule oral drug products.
- Collaborate with Drug Product, Analytical, API, Quality, and Regulatory to support CMC activities and drug application submissions/approvals.
- Develop oral formulations for clinical studies and commercialization.
- Lead formulation and process development to enhance oral bioavailability, stability, and processability.
- Support preparation of CMC regulatory documents.
- Prepare technical reports, batch records, SOPs, publications, and oral presentations.
- Collaborate cross-functionally to optimize formulations and enable technology transfer to CMOs/other sites.
- Support departmental initiatives; maintain safety/regulatory/compliance standards; develop/coach/mentor others.
Qualifications/Experience:
- BS in Pharmaceutical Science, Chemical Engineering, or related field with 9–12 years experience; MS with 6–9 years; or Ph.D. with 4–6 years.
- Hands-on formulation development and pharmaceutical processing experience.
- Knowledge of drug substance/excipients, unit operations (blending, milling, sieving, granulation, tableting, encapsulation, coating, spray drying), CQAs/quality attributes, statistics, risk assessment, and cGMP.
- Experience building CMC dossiers (author/reviewer) and basic regulatory knowledge.
- Problem-solving/troubleshooting, experimental design/execution, independent work, leadership/training, strong communication and interpersonal skills.
Benefits (if eligible): Health (medical/pharmacy/dental/vision), wellbeing programs (e.g., EAP), financial protection (401(k), disability, life/accident, etc.), and paid time off (incl. flexible time off/paid vacation and national holidays).