Posted to MedZilla on 1/17/2020


United States, Group Leader - Downstream Operations SC_MJ_13704-MZ


ProClinical is recruiting for an exciting new opportunity for the permanent position of Group Leader of Downstream Operations opening in Princeton, NJ. This role includes executing and overseeing all downstream operations, such as ensuring cGMP-compliant operations occur within the biologics manufacturing center, and will report to our client’s Director of Manufacturing.


  • Lead a team of up to 12 (3 directly; 9 indirectly).
  • Downstream manufacturing oversight.
  • Scheduling of all relevant activities and personnel.
  • Work diligently (overtime when needed) to meet production schedules.
  • Manage manufacturing operations.
  • Approve cGMP documentation as relevant, including SOPs, Batch Records, Qualification Protocols, etc.
  • Work with quality assurance management to approve executed documentation in support of drug substance release.
  • Coordination with cross functional areas to ensure that the manufacturing schedule is met.
  • Follow all company best practices to minimize cost and meet budgetary requirements.
  • Works with Manufacturing Director and Department of Quality Assurance to establish and execute PAI readiness plan
  • All ad-hoc responsibilities as assigned by management team.

Skills And Qualifications

  • MS/BS degree in life sciences or engineering, or equivalent experience.
  • 12 + years progressive industry experience within a drug manufacturing environment. Commercial manufacturing experience preferred.
  • 5+ years of supervisory experience in a drug manufacturing environment.
  • Expertise in cGMP bioprocess operations.
  • Strong knowledge of cGMP manufacturing operations, and ability to uphold regulatory requirements
  • Experience with PAI readiness.
  • Must be able to provide hands-on leadership, coaching, and coordination of needed actions with a focus on achieving production goals
  • Excellent leadership skills.
  • Excellent English written and verbal communication skills.
  • Excellent problem solving skills.
  • Individual must be able to lift 50 lbs. (minimum), and be able to work physically in order to complete tasks
  • Must have the ability to stand for long periods of time.
  • Individual may be exposed to latex, bleach, dangerous materials, allergens, strong odors, etc., and therefore must be able to follow proper safety precautions (including wearing proper clean room attire) to minimize potential risk and exposure.

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 Mary Jacobs at (+1) 2674774800 or upload your resume on our website -

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.

Please visit our website at


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.