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CMC-Pharma Product Group Associate Director

AbbVie

CMC-Pharma Product Group Associate Director

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and managing projects related to both commercial and pipeline small molecule products. This role serves as a central leader within the S&T PPG group.Independently lead complex cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. Develops and executes the control strategy for Pipeline products with limited oversight/support.Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of the impact on Operations.Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to senior management and regulatory agencies.Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for regulatory submissions.Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.Develop new and less experienced CMC leads through sponsor/mentor relationships.Identify and promote best practices among PDS&T CMC leads.Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

Locations

  • Sligo, SO

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

180,000 - 220,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • CMC leadership and project managementintermediate
  • Cross-functional team collaborationintermediate
  • Regulatory submission preparation and reviewintermediate
  • Technical presentation and communicationintermediate
  • Strategic planning and risk managementintermediate
  • Mentoring and best practices promotionintermediate

Required Qualifications

  • Advanced degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering) (experience)
  • Extensive experience in CMC leadership for small molecule pharmaceuticals, including commercial and pipeline products (experience)
  • Proven track record in managing cross-functional teams and complex projects from Phase II through commercial stages (experience)

Responsibilities

  • Independently lead complex cross-functional PDS&T product teams and represent CMC in interfaces with leadership, operations, and external partners
  • Develop and maintain comprehensive project plans, budgets, timelines, and strategies for technical projects at all development stages
  • Ensure proactive technical ownership of products, processes, and methods; facilitate issue resolution and prioritization with strategic impact understanding
  • Present technical information on drug product/substance manufacturing to senior management and regulatory agencies
  • Prepare and review regulatory submissions through product registration and post-approval life-cycle management
  • Manage multiple complex projects across development, commercialization, and manufacturing stages
  • Develop and mentor new CMC leads, promote best practices, and foster partnerships with key customers and functions

Benefits

  • general: Competitive salary and performance-based incentives
  • general: Comprehensive health, dental, and vision insurance
  • general: Retirement savings plan with company matching
  • general: Professional development opportunities and tuition reimbursement

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OperationsAbbViePharmaceuticals

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AbbVie logo

CMC-Pharma Product Group Associate Director

AbbVie

CMC-Pharma Product Group Associate Director

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and managing projects related to both commercial and pipeline small molecule products. This role serves as a central leader within the S&T PPG group.Independently lead complex cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. Develops and executes the control strategy for Pipeline products with limited oversight/support.Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of the impact on Operations.Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to senior management and regulatory agencies.Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for regulatory submissions.Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.Develop new and less experienced CMC leads through sponsor/mentor relationships.Identify and promote best practices among PDS&T CMC leads.Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

Locations

  • Sligo, SO

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

180,000 - 220,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • CMC leadership and project managementintermediate
  • Cross-functional team collaborationintermediate
  • Regulatory submission preparation and reviewintermediate
  • Technical presentation and communicationintermediate
  • Strategic planning and risk managementintermediate
  • Mentoring and best practices promotionintermediate

Required Qualifications

  • Advanced degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering) (experience)
  • Extensive experience in CMC leadership for small molecule pharmaceuticals, including commercial and pipeline products (experience)
  • Proven track record in managing cross-functional teams and complex projects from Phase II through commercial stages (experience)

Responsibilities

  • Independently lead complex cross-functional PDS&T product teams and represent CMC in interfaces with leadership, operations, and external partners
  • Develop and maintain comprehensive project plans, budgets, timelines, and strategies for technical projects at all development stages
  • Ensure proactive technical ownership of products, processes, and methods; facilitate issue resolution and prioritization with strategic impact understanding
  • Present technical information on drug product/substance manufacturing to senior management and regulatory agencies
  • Prepare and review regulatory submissions through product registration and post-approval life-cycle management
  • Manage multiple complex projects across development, commercialization, and manufacturing stages
  • Develop and mentor new CMC leads, promote best practices, and foster partnerships with key customers and functions

Benefits

  • general: Competitive salary and performance-based incentives
  • general: Comprehensive health, dental, and vision insurance
  • general: Retirement savings plan with company matching
  • general: Professional development opportunities and tuition reimbursement

Target Your Resume for "CMC-Pharma Product Group Associate Director" , AbbVie

Get personalized recommendations to optimize your resume specifically for CMC-Pharma Product Group Associate Director. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "CMC-Pharma Product Group Associate Director" , AbbVie

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

OperationsAbbViePharmaceuticals

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No related jobs found at the moment.