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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Program Management

Worcester, Massachusetts Req ID 2206733 Category Manufacturing & Operations Division AbbVie

Associate Director, Program Management

Purpose:

The Associate Director of Program Management drives the systems and personnel responsible for operational demand planning, manufacturing program technical transfer, and manufacturing program management.  This includes actively managing incoming demand requests from Research & Development, In-licensing, Third-Party Manufacturing and Commercial and includes new product introductions and product reintroductions that both support AbbVie’s pipeline and our External Contract Manufacturing business partners. Leads the Manufacturing Project Management Office (MPMO) supporting six manufacturing suites at ABC and Technical Transfer function responsible for authoring Batch Record documentation that defines the manufacturing processes.  The functions led provide project management for all manufacturing and technical activities needed to ensure successful tech transfer and commercialization of the ABC Manufacturing Portfolio by integrating the efforts of R&D, S&T, Quality, Supply Chain and Regulatory.

Responsibilities:

  • Assemble and lead matrixed cross-functional teams of Project Managers and Manufacturing Associates responsible for driving readiness of manufacturing campaigns. 
  • Manage demand planning processes to integrate demand from both internal and external clinical and commercial biologics bulk drug substance production needs
  • Drive continuous improvement for the definition, communication, and standardization of product (re)introduction timelines and milestones, integrating the needs of process development, supply chain, engineering, quality, regulatory and production. 
  • Drive key scenario planning efforts to optimize plant capacity as an input to financial planning processes or in response to key demand changes or process upsets.
  • Proactively identify and drive manufacturing and release related issues to closure by working with and elevating through appropriate functions to effectively troubleshoot and drive decisions
  • Manage multiple large projects concurrently, operating with minimal supervision
  • Understand project drivers, requirements, scenarios, and options. Proactively drive development of contingency and/or risk mitigation plans. Accountable for ensuring programs are robust from a technical, compliance and business perspective (i.e. regulatory requirements, AoS)
  • Manage competing timelines and make difficult decisions regarding priorities among projects.
  • Effectively communicate and present project status to Operations senior management and stakeholders
  • Accountable for setting and achieving program and project plans, including timelines and expenses, that meet business and organizational objectives and ensuring those plans are achieved.
  • Partner with site Finance to assist with monthly actuals, LBE, development of Key +/- scenarios and Plan/LRP schedules per financial schedule.
Qualifications:

Qualifications:

  • Bachelor’s Degree in Engineering, science, or closely related discipline, or equivalent technical experience plus demonstrated competence, MBA preferred
  • 10+ years of combined experience in positions related to process development, project management, engineering/process support and manufacturing
  • Must have strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations
  • Must have demonstrated organizational and planning skills, excellent verbal and written communication skills while managing large  programs in the pharmaceutical industry
  • Must have demonstrated strong project management skills with successful delivery of projects. Demonstrated ability to operate effectively with minimal to no supervision.
  • Must be able to effectively facilitate the resolution of complex scientific, technical, analytical and business issues across functional lines
  • Significant manufacturing plant experience a must
  • Experience with biologics processing, process development, and release preferred
  • Demonstrated ability to effectively communicate with senior and executive management.
  • PMP certification a plus

 

Key Stakeholders:

  • Interface w/executive leaders across Operations and Research & Development
  • Lead across complex cross-functional teams including representatives from: Manufacturing, Supply Chain, Engineering, QA, QC, S&T, R&D, regulatory affairs, & finance.
  • Accountable to Executives on all phases of projects
Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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