Scientist 2, Downstream Bioprocessing
Proclinical is currently recruiting a Scientist of Downstream Bioprocessing for a pharmaceutical company located in King of Prussia, PA. Successful candidate will develop, evaluate, and support industrialization and introduction of technologies essential to large-scale cGMP production.
- Transfer of process technology from Bioprocess development groups to GMP Operations.
- Conduct facility fit assessments and lead process introduction activities for downstream unit operations.
- Monitor technical operations of the process through communication with Manufacturing Scientists.
- Coordinate activities between Development groups.
- Represent the Process Technology department at multi-disciplinary matrix teams. Present results/conclusions at these meetings.
- Responsible for successfully troubleshooting production problems and for the technical success of multi-million-dollar biopharmaceutical production campaigns that support progression of the Biopharm R&D portfolio.
- Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
- Author manufacturing and process sections of regulatory submissions and responses to regulatory questions.
- Author and approve batch documentation.
- Conduct batch planning activities, such as raw materials management and/or water runs.
- Provide training and guidance to Manufacturing Scientists and less experienced personnel.
Skills and Requirements:
- MS with 4+ years relevant experience, or BS with 6+ years of relevant experience.
- Experience in bioprocessing, with a preferred background in downstream processing disciplines.
- Experience in biopharmaceutical process development, technology transfer, scale-up, and cGMP batch execution/troubleshooting.
- Knowledgeable in all aspects and unit operations that comprise the bioprocess and biomanufacturing downstream platform.
- Experience in lab/pilot scale protein purification methods including chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation.
- Proficient in cGMPs and regulatory requirements.
- Proficient in technology transfer and process scale-up.
- Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable.
- Excellent written and oral communications skills.
- Excellent organizational, collaboration, and teamwork skills.
- Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization.
- Experience in project management and delivery, including ability to prioritize and forward plan courses of action.
- Works independently with minimal to no direct supervision.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.