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Scientist

Date: Jun 10, 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!
 
R&D:
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
 

Job Description

The Scientist at Process Development department of Biologics CMC will lead or support recombinant protein purification process development for production and commercialization of novel biologics and biosimilar molecules. The Scientist will plan and execute monoclonal antibody purification studies with minimal supervision.
In addition, the Scientist will lead or contribute to downstream (protein purification) process development, characterization, and validation in supporting all related CMC activities.


Other duties:

  • Independently design and perform monoclonal antibody purification process development studies at bench scale and/or pilot scale, using engineering principles 
  • Perform data analysis and troubleshooting on downstream process development studies including but not limited to chromatography, TFF, viral inactivation, viral filtration, and viral clearance
  • Contribute to technology transfer to internal or external manufacturing sites
  • Author technical reports on process development and tech transfer activities
  • Perform a compliant laboratory operation in accordance with SOPs, internal procedures and policies
  • Interact and communicate with manufacturing sites to provide technical leadership
  • Perform manufacturing activities at the internal clinical manufacturing site as needed
  • Support manufacturing deviation investigations as a Subject Matter Expert (SME)
  • Contribute to regulatory filing documents (IND, BLA, MAA, etc.) when needed.

Qualifications

Required Qualifications:

  • PhD in Biology, Biotechnology, Biochemistry, Chemical Engineering, Biochemical Engineering or other related science/ engineering field with 0+ years of experience in biopharmaceutical/ biotech industry, or Master’s degree with minimum 4 years of recombinant protein purification experience in biopharmaceutical/ biotech industry, or Bachelor’s degree with minimum 6 years of recombinant protein purification experience in biopharmaceutical/ biotech industry.
  • Minimum 2 years of experience in design and execution of studies for protein purification process development.

 

Preferred Qualifications:

  • Experience in downstream process characterization
  • Experience in Process Performance Qualification (PPQ) and commercialization of biopharmaceuticals.
  • In depth understanding of principles/mechanisms of chromatography and filtration technologies.
  • Hands-on experience in chromatography and filtration systems
  • Ability to apply public knowledges from literatures, such as scientific publications, and regulatory guidelines, on biopharmaceutical production in solving problems in downstream processes.
  • Proficiency in process data analysis using statistical and multivariate analysis tools and models
  • Good understanding of cGMP principles, and how they are related to process development of biopharmaceuticals
  • Experience in authoring technical documentation and regulatory filing documents
  • Excellent verbal and written communication skills 
  • Hands-on experience in viral clearance studies
  • Proficiency in software such as Unicorn and JMP
  • Hands-on experience in applying high-throughput methods (Tecan) for process development

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Reports To

In process of validation

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.
 
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.


 


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