Senior Manager Group Leader Manufacturing Support Job

SENIOR MANAGER GROUP LEADER MANUFACTURING needed for a CONTRACT opportunity with Yoh's client located in PLAINSBORO, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Experience with biologics drug substance scale-up and manufacturing
- Equipment qualification and process validation including 21 CFR Part 11 compliance
- Experience in cGMP environment

WHAT YOU'LL BE DOING:

- Lead a multi-disciplined group (currently 4 FTEs) responsible for process engineering, equipment qualification, and logistics
- Create of RFP's and URS' for customized automation and integration of packaged systems such as single use bioreactors, chromatography systems, TFF systems, depth filtration systems
- Lead evaluation of electronic systems to replace paper based systems for manufacturing operation including a process historian data acquisition system in the context of 21 CFR Part 11 compliance
- Execute site VMP to ensure a constant state of compliance in a multi-product/multi-phase manufacturing facility
- Review, oversight and coordination of equipment qualification program
- Author, review, and/or approve documentation, including but not limited to, master batch records, standard operating procedures, production bill of materials, process flow diagrams, and campaign summary reports
- Troubleshooting/investigation of process non-conformances and deviations
- Manage material specification process.
- Provide technical advice on raw material monographs to ensure compliance with applicable region's compendia
- Compile process data from clinical batches to establish critical processing parameters and PAR

WHAT YOU NEED TO BRING TO THE TABLE:

- BS. or M.S. in Chemical Engineering, Life Sciences or equivalent
- Minimum of six (6) years progressive industry experience with biologics drug substance scale-up and manufacturing
- Demonstrated ability in clinical cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs
- In-depth knowledge in the principles of process scaling from process development to clinical manufacturing as well as single-use technology
- Experience with development or manufacturing as it relates to biosimilars or comparability is a plus

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Chelsea Tevis

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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