Teva Sr Scientist 

United States, Pennsylvania, East Bradford Township 

641701210

Key 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

Required 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
Preferred Qualifications:
• 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

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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