27 days old

Associate Scientist, Drug Product Development & Operations

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Tevas 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 and Operations (DPDO) is a function within Biologics CMC dedicated to development of formulation, drug product configuration and manufacturing process of the non-clinical and the clinical drug product lots. You will play a key role in DPDO to support the formulation development of Teva innovative and biosimilar product pipeline for manufacture into drug product.

 

As an Associate Scientist, you will primarily lead the studies, execute analytical test methods, organize the data and author related technical documents, all in compliance with applicable policies. You will also serve as owner for multiple analytical instrumentation that supports formulation development, which includes writing supporting SOPs, working as subject matter expert (SME), training as needed and maintaining the instrumentation. In addition, you will assist in development of high throughput and high concentration platforms and manufacture of non-clinical drug product lots.

 

Responsibilities:  

  • Lead execution of the formulation studies or experiments based on QbD principles, evaluate quality of the data and work on ways to improve data analysis and presentation formats.
  • Support development of a high throughput platform processes for formulation and process development of drug products for innovative biologics or biosimilars.
  • Develop or transfer, and perform routine analytical methods including chromatographic, electrophoretic, biophysical and other general test methods.  
  • Maintain a laboratory notebook including timely recording of experiments, data analysis and review.
  • Author protocols, reports, and technical documents, and support authoring other relevant CTDs for regulatory filings including IND/IMPD and marketing applications as needed.
  • Support outsourcing activities to external contracting organizations to accomplish project goals as needed.
  • Support development of lyophilized biologic products, scale up and tech transfer activities as needed.  
  • Support working on novel methodologies for development of high concentrated protein formulations and extractables and leachables program. 
  • Assist in the set-up and maintenance of a new state of the art lab including ownership of instrumentation, writing SOPs and serve as subject matter expert for the related technologies.
  • Effectively work in collaboration with different functions in the CMC as well as other non-technical teams on site to facilitate routine operations.

Qualifications

What you will bring to the role:

  • Bachelors in chemistry, biology, pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with a minimum of 7 years of experience in analytical and/or development experience with protein molecules, or Masters in a related discipline with a minimum of 5 years, or Ph.D. in a similar discipline with a minimum of 1 year of experience in above.
  • Minimum 3 years hands-on experience in analytical testing using physical and biochemical, characterization methods, such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, HPLC, DLS, DSC, and CD spectroscopies.

 

Preferred Qualifications:

  • Excellent planning, verbal and written skills. Good documentation practices.
  • Proficient in Microsoft Office Suite of Programs.
  • 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 better processes.
  • Experience working in GMP environment. 
  • Knowledge of current regulatory guidelines related to biologic pharmaceutical development.

Function

Research & Development

Sub Function

Biological Research

Reports To

Associate Director, R&D

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 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.  

Categories

Posted: 2021-03-25 Expires: 2021-04-24

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Scientist, Drug Product Development & Operations

Teva Pharmaceuticals
West Chester, PA 19380

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