Scientist, Drug Product Development

Date: May 24, 2024

Location:

West Chester, United States, Pennsylvania, 19380

Company: Teva Pharmaceuticals

Job Id: 56153

**Who we are**

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

**The opportunity**

Teva's Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for the development of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Drug Product Development (DPD) is a function within Biologics CMC dedicated to development of formulation, drug product manufacturing process, and process tech transfer to GMP manufacturing sites.

As a Scientist, the successful candidate will plan and execute studies, generate and organize data, author related technical documents in compliance with regulatory guidance and applicable policies. Additionally, the successful candidate will serve as subject matter expert (SME) and owner for multiple analytical instrumentation to support drug product development.

This position is located out of West Chester, PA and the person hired is required to be onsite 5 days a week

**How you'll spend your day**

Design and execute the experiments based on QbD principles, evaluate quality of the data and work on ways to improve data analysis and presentation formats.

Represent DPD for selected project in cross functional project management teams, as needed.

Effectively collaborate with different CMC functions as well as other non-technical teams in Teva to facilitate routine operations.

Design and execute formulation and process development studies.

Perform routine analytical tests. Generate and organize data in compliance with regulatory guidance and applicable policies.

Author protocols, reports, technical documents and other relevant regulatory filings documents including IND/IMPD and marketing applications, as needed.

Assist in the set-up and maintenance of research labs including ownership of instrumentation, authorize instrument working instructions and serve as subject matter expert for the related analytical technologies.

Support manufacturing technology transfer, as appropriate.

**Your experience and qualifications**

**Minimum Requirements:**

MS or BS in pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 4 or 8 , respectively, years relevant experience, Ph.D. in a similar discipline with 0-4 years relevant experience.

Minimum 3 years hands-on experience in biologic product development and analytical testing using biophysical and biochemical, characterization methods, such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, HPLC, DLS, DSC, and CD spectroscopies.

Excellent planning, verbal and written communication skills.

**Preferred Qualifications:**

Formulation and/or process development experience including the analysis or characterization of proteins required.

Experience in application of a statistical software (eg. JMP), or implementation of QbD elements.

Highly motivated individual, with ability to work in a team environment and build productive relationships within or across departments.

Ability to troubleshoot and determine creative solutions to achieve better processes.

Experience in GMPs, biopharmaceutical industry and/or writing of regulatory submission documents.

Proficient in Microsoft Office Suite of Programs.

**Enjoy a more rewarding choice**

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

**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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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.

EOE including disability/veteran