CMC Leader - Biotech/Pharmaceutical Industry
beBeeManufacturing6 months ago
San Diego, CA, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Position Overview
Treeline Biosciences is committed to bringing forward drugs that benefit patients. We are looking for a skilled Head of CMC to lead our CMC-related activities. The successful candidate will be responsible for overseeing outsourced manufacturing, including technology transfer and quality control. They will work closely with Contract Manufacturing Organizations (CMOs) to optimize processes and ensure GMP manufacture.
Key Responsibilities
- Formulate a comprehensive strategy for drug substance and drug product development to meet clinical and commercial demands.
- Evaluate and improve product quality, drive regulatory approvals, and enhance operational efficiency of the supply chain.
Required Qualifications
- Strong background in Pharmaceutical Chemistry or a related field.
- 10+ years of experience in the biotech/pharmaceutical industry.
- Expertise in drug substance development, formulation development, and process validation experiments.
Required Skills
Technology Transfer
Pharmaceutical Chemistry
CMC Strategy
CMO Collaboration
GMP Manufacturing
Drug Substance Development
Process Validation
Quality Control
Formulation Development