Teva Pharmaceutical Industries West Chester , PA 19380
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!
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.
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
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
Research & Development
Drug Analysis and Formulation
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