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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, CMC Sciences

Primary Worcester, Massachusetts Req ID 2212763 Category Regulatory Affairs Division AbbVie

Purpose:

Leads global biologics drug substance Chemistry, Manufacturing and Controls (CMC) teams of functional representatives from various departments and divisions to support programs at all stages of development from pre-clinical through BLA. Accountable for creating and driving CMC development plans in collaboration with line functions and in alignment with overall program objectives. Serves as the spokesperson for CMC biologics drug substance functions and ensures information flow among and various line functions.

Responsibilities:

  • Critically evaluates and integrates drug substance CMC plans and strategies with the overall product timelines and corporate business objectives. Decision making will often require assessment and integration of biologics process, engineering and analytical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.
  • Serves as spokesperson for the drug substance CMC project team on cross-functional product teams and ensures information flow among line functions. Ensures high quality science and deliverables and collaborates to ensure compliance with global regulatory and quality requirements. Responds to urgent regulatory queries, and participates in pre-approval inspections.
  • Responsible for the preparation and review of regulatory filings.
  • Manages projects utilizing a matrix management approach. Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Develops strategies to improve workflows and best practices for drug substance CMC leads.
  • Develops drug substance program budgets, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall drug substance CMC quality of a given project. Ensures timely execution of the project plan to deliver high quality with respect to science, technology, compliance, and cost effectiveness.
  • Leads biologics drug substance CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, and conducts periodic reviews to ensure that phase transition criteria are met.
  • Apprises CMC and S&T management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.
  • Supports and implements corporate and divisional initiatives and strategies. Promotes scientific and entrepreneurial thinking, encourages creativity, and manages quality and results with respect to science, time, budget and resources.
  • Ensures compliance with regulatory, health, safety and environmental requirements. Stays well informed of developments in the global technical, regulatory and compliance arena and industry practice.
  • Ensures high level of morale in the CMC team.

Qualifications:

  • Bachelor’s degree with at least 16 years of relevant experience; Master’s Degree with at least 14 years of relevant experience; or PhD with at least 8 years of relevant experience required to effectively manage global teams and all biologics drug substance CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources.
  • Must demonstrate excellent scientific writing and verbal communication skills.
  • Must have a good working knowledge of regulatory requirements and strong technical knowledge of biologics process and analytical development.
  • Must have CMC interdisciplinary experience and expertise. Prior experience must include leadership in technical roles.
  • Must demonstrate negotiating, influencing, and leadership skills, and ability to collaborate with and lead highly matrixed teams.
  • Strong project management skills with ability to manage multiple programs.  
  • Must demonstrate creativity in implementing entrepreneurial thinking and ability to make smart business decisions.
Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
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