Sr Scientist

Role Summary

Senior Scientist at West Chester, PA to drive process development, characterization, and technology transfer for biological drug products, and represent DPD 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