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Scientist

Date: Apr 1, 2021

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

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

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 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 Drug Product development of Teva innovative and biosimilar product pipeline.

 

As a Scientist, you will lead projects and studies in process development in support of tech transfer, execute analytical test methods, organize the data and author related technical documents. You will also serve as owner for multiple analytical instrumentation that supports drug product development, working as subject matter expert (SME), training as needed and maintaining the instrumentation.

 

Responsibilities

  • Design and execute experiments, implementing the use of QbD principles and DOE, to develop and transfer manufacturing processes for early and late stage candidates from R&D to clinical and commercial sites
  • Author protocols, reports, technical documents and other relevant s for regulatory filings including IND/IMPD and marketing applications as needed.
  • Support primary packaging, e.g. vials or PFS identification and CCIT testing.
  • Support PPQ activities by testing samples using appropriate analytical methods including but not limited to chromatographic, biophysical and other general test methods. 
  • Execute analytical tests to support formulation, including chromatographic, biophysical and general physicochemical testing methods.
  • Document data following applicable lab procedures and current good documentation practices
  • Work in collaboration within CMC and engineering and equipment supporting personals on site to facilitate routine operations.
  • Coordinate with external contracting research/manufacturing organizations to accomplish project goals as needed and serve as a point of contact on the outsourced activities.
  • Support working on novel integrated approaches for development of biosimilar drug products.
  • Represent DPDO as DP lead at cross functional teams for selected projects and may directly participate in the CMC teams or other sub-teams in site-wide meetings, as needed.

Qualifications


Required Qualifications:
 

  • Bachelor’s in chemistry, biology, pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with a minimum of 10 years of experience in analytical and/or development experience with protein molecules, or Master’s in a related discipline with a minimum of 8 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 successful drug product process development and technology transfer operations, analytical testing using biophysical and biochemical, characterization methods, such as general appearance, opalescence, osmolality, MFI, HIAC, viscosity, HPLC, DLS, DSC, and CD spectroscopies.


Preferred Qualifications:

  • Experiences in developing successful clinical/commercial processes for manufacturing sites. 
  • Experiences in leading process design and risk management activities and documentation for technology transfer.
  • Experience with materials, testing, and regulatory requirements on drug product container closure systems.  PFS and single-use system development experience highly preferable.
  • Experiences in authoring sections and supporting filing of IND/IMPD and BLA/MAA.
  • Current knowledge on pharmacopoeias, regulatory guidelines and ISO standards related to biologics manufacturing, parenteral drug product manufacturing, and cGMP operation.
  • Familiar on bio/analytical methods and their utilization on evaluating impact to drug product as a result of process stresses
  • Current knowledge on aseptic processing and drug delivery systems/technologies
  • Understanding of cGMP facility and unit operations of biopharmaceutical manufacturing
  • Excellent project management, verbal/written communication, and interpersonal skills.
  • Experience in formulation development or drug product manufacturing or scale-up of biological drug products.
  • Experience in application of QbD principles and DOE concepts in design, execution, and interpretation of formulation development experiments using statistical software (e.g. JMP).
  • Good skills in study planning, reporting, interpretation and documentation of scientific results.
  • Excellent ability to work in a team environment and build productive relationships within or across departments.
  • Excellent skills in troubleshooting and determining creative solutions to achieve better processes.

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Reports To

Senior Scientist

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.


Nearest Major Market: Philadelphia