Associate Director,Manufacturing Technology/Process Development

At Proclinical, we are seeking a dynamic individual to fill the role of Associate Director of Manufacturing Technology/Process Development, based in Cranbury, NJ.

Responsibilities

• Lead group responsible for process engineering, equipment qualification, tech transfer, and process scale-up.
• Manage creation of RFP's and URS' for customized automation and integration of packaged systems.
• Lead evaluation of electronic systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance.
• Manage execution of site VMP to ensure a constant state of compliance in a multi-product/multi-phase Manufacturing facility.
• Manage coordination of equipment qualification and validation program.
• Manage drafting, review, and/or approval of documentation.
• Manage investigations and troubleshooting of all equipment, processes and related deviations.
• Serve as MTS representative on all assigned committees and task forces.
• Ensure seamless and rapid technology transfers from Process Development to Manufacturing.
• Team with PD to draft and review/approve technology transfer protocols.
• Provide technical support and advice on the material specification process and raw material monographs.
• Compile process data from clinical batches to establish critical processing parameters and PAR
• Team with PD to lead data review meetings and provide data analysis.

Skills And Qualifications

• BS/MS in a relevant field and 8+ years of progressive industry experience.
• Experience with biosimilar development or manufacturing preferred.
• Demonstrated ability in clinical cGMP bioprocess operations, particularly processes of mammalian expressed glycoproteins, mAbs, or ERTs
• In-depth knowledge in the principles of process scaling from process development to clinical manufacturing to commercial manufacturing
• In-depth knowledge of single-use technology
• Working knowledge of equipment qualification and process validation including 21 CFR Part 11 compliance
• Excellent written, verbal, and interpersonal communication skills, as well as English fluency.

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 Matthew Goldberg at (+1) 2674056995 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.