Process Development Scientist
Proclinical is currently recruiting for a Process Development Scientist with a pharmaceutical company located in New Haven, CT.
- Evaluate cell line development technologies; develop and optimize robust cell line generation and clone screening processes
- Develop next generation platform medium and feed to improve volumetric productivity
- Develop and optimize robust, scalable upstream processes for GMP manufacturing of biologics for clinical and commercial supply
- Lead external projects to evaluate and implement new platform and/or technology to improve the efficiency for current work flows
- Lead process scale up evaluation and support process tech transfer
- Lead small-scale validation and process characterization studies.
- Author internal technical protocols, reports which may have strong interface with other technical functions (e.g. TS), regulatory (e.g. RA) and compliance (e.g. QA/QC) and peer-reviewed external journal articles.
- Serve as subject matter expert for cell line/upstream/downstream processes across the internal and external manufacturing network for clinical and commercial processes
- Manage a group of associate scientists to support professional development
Skills and Requirements:
- Master's Degree required, other advanced degrees preferred
- Must have extensive technical knowledge of cell line, upstream, or downstream process development for biologics
- Must have working knowledge of regulatory guidelines related to cell line/upstream/downstream development and process characterization including viral clearance and process validation
- Experience using AKTA systems and unicorn software for purification development is preferred
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.