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Biologics Operations SME

Job Attributes

Job Id:

17649

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is seeking a Biologics Operations Subject Matter Expert in Summit, NJ to consult for a global bio-pharmaceutical company and assist with the development and commercialization of products for cancer treatment.

Operational role within Manufacturing Supply of Biologics Development. Establish and oversee operational aspects of supply chain for clinical trials, and ensure timely scheduling, transport, processing, release and return to the clinical sites of patients. Provide oversight for CMO in EU and set up operational models abroad. 

Responsibilities for the Biologics Operations SME:

  • Provide project management expertise working with cross functional teams
  • Attend and participate in study team meetings, ensure meeting minutes are taken
  • Operational oversight of CMOs and enforcement of timely communication, problem sovling

Qualifications for the Biologics Operations SME:

  • 4+ years of experience working with external manufacturing and visiting CMO sites, Biologics experience preferred
  • ClinOps, Study Management Background a plus
  • Bachelor’s degree in Life Sciences or related field preferred

Compensation for the Biologics Operations SME:

  • Salary is commensurate to experience
  • Full Benefits: Medical, Dental, Vision, Rx, 401k plan

Please send all qualified resumes to Karen Pallone at kkpallone@pipercompanies.com 

Keywords:

Cdmo, cmo, contract manufacturing organization, biologics, supply chain, quality, regulatory, operations, validation, commercial, production, external manufacturer, process scale-up, ppq, ra, qbd, cmc support, tech transfer, technology transfer, cgmp, gmp, cgcp, gcp

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Job Id:

17649

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies