CMC External Manufacturing Leader — Drive Global Supply & Compliance

AbbVie Inc.

North Chicago (IL)

Sur place

USD 148 000 - 209 000

Plein temps

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Avantages offerts par ce poste

Paid time off
Medical/dental/vision insurance
401(k)

Résumé du poste

AbbVie Inc. in North Chicago, IL seeks a Principal Manager, CMC External Manufacturing to lead DS/DP cGMP manufacturing oversight at CRO/CDMOs, manage external budgets, and ensure compliance with quality and regulatory standards.

This onsite role drives supplier reviews and site visits, supporting pipeline and regulatory filings. The ideal candidate holds a PhD in chemistry or related field (or MS with relevant experience) and has experience presenting to senior stakeholders, optimizing

Qualifications

  • PhD in chemistry, organic chemistry, chemical engineering, analytical chemistry or related field, or foreign education equivalent.
  • 1 year working in academic or industry setting supporting development & synthesis of pre-clinical or clinical stage small molecule or natural products.
  • Experience presenting scientific material to peers, business stakeholders & senior management.
  • Experience supporting reaction optimization & developing protocols for scale-ups.
  • Experience preparing research proposals & managing research projects.
  • Or MS in chemistry, organic chemistry, chemical engineering, analytical chemistry or related field, or foreign education equivalent, & 3 years working in related setting.

Responsabilités

  • Manage DS/DP cGMP manufacturing and technical oversight at CRO/CDMO, & external budget.
  • Ensure CRO/CDMO compliance with quality, finance, ethics, & regulatory standards.
  • Lead Supplier Review Board activities, & conduct site visits for diligence and audits.
  • Stay updated on pipeline needs for CMC supply chain planning & support regulatory filings.

Connaissances

Written & oral presentations
Reaction optimization
Research proposals
Publications & presentations

Formation

PhD in chemistry or related field
MS in chemistry or related field

Description du poste

AbbVie Inc. in North Chicago, IL seeks a Principal Manager, CMC External Manufacturing to lead DS/DP cGMP manufacturing oversight at CRO/CDMOs, manage external budgets, and ensure compliance with quality and regulatory standards.

This onsite role drives supplier reviews and site visits, supporting pipeline and regulatory filings. The ideal candidate holds a PhD in chemistry or related field (or MS with relevant experience) and has experience presenting to senior stakeholders, optimizing

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