Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Scientist I - 1487

Expired Job

Teva Pharmaceutical Industries West Chester , PA 19380

Posted 2 months ago

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

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 halflife 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 the drug product configuration and the manufacturing operations of the non-clinical and clinical drug product lots. The current position will be part of the drug product development group primarily intended to contribute to the development of a high throughput platform process for development of early phase drug products of innovative therapeutics in Teva Biologics pipeline.

Responsibilities

  • Focus on development of platform processes for formulation and process development of drug products for innovative biologics

  • Develop high throughput methods and integrate in the development process of a formulation and/or drug product

  • Design and develop efficient methods of lyophilization for biologic drug products and work on tech transfer and scale-up issues as needed

  • Transfer and perform routine analytical methods including chromatographic, electrophoretic, biophysical and other general test methods

  • 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

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

  • Directly participate in the CMC, other sub-team and site-wide meetings as needed

  • Coordinate with external contracting organizations to accomplish project goals as needed and serve as point of contact on the outsourced activities

  • Support working on novel methodologies for development of high concentrated protein formulations and extractables and leachables program for late stage projects

  • 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

  • Ph.D. in pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 0-5 years experience, or MS in a similar discipline with 5-10 years experience.

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

  • Excellent planning, verbal and written skills. Good document practices is a must.

  • 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 or writing of regulatory submission is a plus.

  • Proficient in Microsoft Office Suite of Programs

Function

Research & Development

Sub Function

Drug Analysis and Formulation

Reports To

In process of validation

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: Philadelphia


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Scientist / Senior Manager For Cell Culture Process Development

Teva Pharmaceutical Industries

Posted 3 days ago

VIEW JOBS 11/15/2018 12:00:00 AM 2019-02-13T00:00 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 The Senior Scientist/Senior Manager for Cell Culture Process Development will be a key talent responsible for all aspects of cell culture processes design and optimization, working with our internal partners in Research and Development, Manufacturing, Quality, Regulatory and external CROs, and CMOs to enable speed to clinic and robust commercial manufacturing process design, characterization, process validation and regulatory filings. Responsibilities Subject matter expert in all aspect of cell culture process design, optimization, characterization, and implementation of integrated control strategies applying QbD principles. Upstream development for early to late stage projects, support scale up and technology transfer to internal or external manufacturing facilities. Evaluate next generation high productivity cell culture process technology and define the strategy for implementation. Ensure effective information flow, timeline execution, trouble shooting, and issue resolution in multi-disciplinary matrix organization. Author technical reports. Write and review CMC sections of regulatory filings and regulatory question responses. Provide scientific leadership, mentor and develop junior employees, and create a working environment that values scientific rigor, collaboration and accomplishment with shared responsibility and a sense of urgency. Qualifications Ph.D in Chemical/Biochemical Engineering or related field with 4+ years relevant experience in biopharmaceutical environment or MS with 9+ years of relevant experience. Hands on experience with process design, optimization and scale up. QbD approach in process development and process characterization. Working knowledge of analytical techniques for product characterization. Experience in supporting tech transfer and PPQ. Versed in cGMP, biologics CMC regulations, experience in preparing regulatory documents. Managerial experience is preferred. Experience with high productivity cell culture process design and optimization is preferred. Function Research & Development Sub Function Drug Analysis and Formulation 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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. Nearest Major Market: Philadelphia Teva Pharmaceutical Industries West Chester PA

Scientist I - 1487

Expired Job

Teva Pharmaceutical Industries