Director, CMC Product Development — Late-Stage Strategy

AbbVie Inc.

Chicago (IL)

On-site

USD 180,000 - 280,000

Full time

6 days ago
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Job summary

AbbVie Inc. seeks a Product Development Director (PDD) for the PDS&T organization to oversee CMC strategy for late-stage assets. You will lead the PPDST and collaborate with AST to align with clinical and regulatory development plans across modalities, including small molecules, biologics, and devices.

The role requires directing CMC development plans, managing risks, and communicating with leadership. Strong leadership, negotiation, and strategic thinking are essential for success in a dynamic,

Qualifications

  • Must lead CMC teams across multiple programs and align with AST/OSPL.
  • Strong scientific writing and verbal communication abilities.
  • Understanding of regulatory, quality, and compliance requirements for global filings.

Responsibilities

  • Represent CMC in AST, ensure information flow across functions.
  • Integrate drug substance, product, and device inputs for CMC strategies.
  • Manage multiple projects, prioritize work, and optimize resource use.
  • Review contracts with external partners and manage budgets.

Skills

CMC Leadership
Regulatory knowledge
Project management
Strategic thinking
Communication skills

Education

Bachelor’s Degree in a relevant field
Master’s Degree in a related field
PhD in a related discipline

Job description

AbbVie Inc. seeks a Product Development Director (PDD) for the PDS&T organization to oversee CMC strategy for late-stage assets. You will lead the PPDST and collaborate with AST to align with clinical and regulatory development plans across modalities, including small molecules, biologics, and devices.

The role requires directing CMC development plans, managing risks, and communicating with leadership. Strong leadership, negotiation, and strategic thinking are essential for success in a dynamic,

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