Sr Scientist
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
Teva’s Global R&D division develops new medicines, devices, and combination products to benefit patients worldwide. Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission through BLA filing. Drug Product Development (DPD), part of Biologics CMC, handles formulation, manufacturing processes, and technology transfer to GMP sites. We are hiring a Senior Scientist at West Chester, PA, to drive process development, characterization, and technology transfer for our biological drug products, and represent DPD on cross-functional teams.
How you’ll spend your day
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
Your experience and qualifications
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
Enjoy a more rewarding choice
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.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
