Bench Scientist 2

Proclinical is currently seeking a Bench Scientist for a pharmaceutical company located in King of Prussia, PA. Successful candidate will be responsible for process technology transfer from Bioprocess development groups to GMP Operations. Conducts facility fit assessments and leads process introduction activities for downstream unit operations. Monitors technical operations of the process through communication with Manufacturing Scientists.

Job Responsibilities:

• Coordinate activities between Development groups. Represent the Process Technology department at multi-disciplinary matrix teams. Present results/conclusions at these meetings.
• Troubleshoot production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns that support progression of the R&D portfolio.
• Conduct batch planning activities, such as raw materials management and/or water runs.
• Provide training and guidance to Manufacturing Scientists and less experienced personnel.
• Develop, evaluate, and support industrialization and introduction of technologies essential to large-scale cGMP production.
• Monitor processes in Downstream Purification. Collect information and prepare/maintain a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle.
• Ensure that processes being transferred and supporting documentation are enough to support consistent production and regulatory filings.
• Prepare and/or approve documents for use in technology transfer and manufacturing. Author documents for regulatory purposes.
• Progress the industrialization of technology essential to large scale cGMP production. Solve process and equipment problems. Recommend equipment and procedures.
• Coordinate activities between various Biopharmaceutical Development and Supply groups.

Skills and Requirements:

• PhD in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with 2+ years' relevant experience, OR MS in these disciplines with 4+ years' relevant experience, OR BS in these disciplines with 6+ years of relevant 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.
• 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.

To Apply:

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.

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