Sr Scientist
Teva Pharmaceuticals
Full-time
Remote friendly (West Chester, PA)
United States
Operations
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Role Summary
Senior Scientist at West Chester, PA to drive process development, characterization, and technology transfer for biological drug products, and represent Drug Product Development on cross-functional teams.
Responsibilities
- Responsible for developing drug product manufacturing processes
- Design and implement process characterization
- Author protocols, development reports, risk assessments, and other technical documentation
- Facilitate and support technology transfer to pilot manufacturing sites for clinical supply production
- Lead cross-functional team to manage tech transfer to commercial sites
- Represent DPD on cross-functional matrix teams pertaining to biosimilar and novel biologic products at Teva
- Coordinate, support, and liaise with GMP manufacturing facilities and / or external contract organizations regarding the production of non-clinical and clinical drug product batches
- Provide technical expertise for resolving issues related to drug product processing technologies and equipment
- Serve as a subject matter expert, supporting manufacturing operations through technical evaluation of change controls, deviations, and implementation of corrective and preventive actions
Qualifications
- Ph.D. in pharmaceutical sciences, biochemistry, chemical engineering, or related field with 5+ years of experience; MS with 7+ years; or BS with 10+ years relevant experience
- Biologic drug product development expertise
- Experience developing drug product manufacturing processes, including aseptic processing training
- Skilled in DP process risk assessment and characterization
- Experienced in working within cross-functional teams, with ability to build cross-departmental relationships
- Knowledge of CMC requirements for regulatory submissions (INDs, BLAs) and experience writing DP sections
Skills
- Experience working with manufacturing sites, external service partners and CMOs
- Familiar with single-use manufacturing technologies
- Experience with application of Quality by Design (QbD) to drug product development
- Strong organizational skills and attentive to detail
- Excellent written and oral communication skills