Associate Director, CMC-Pharma Product Group

AbbVie • Waltham, MA

22h

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Position will be responsible for CMC leadership and project management for existing and new biologics projects from the drug substance perspective.

Requirements

• Ph.D. in biochemistry, biochemical engineering, cell biology or related field with 8+ years of industrial experience (or equivalent) or Master degree in above mentioned field with 16 years of relevant experience, is required.
• Very strong writing, presentation and communications skills are required.
• Significant technical understanding of biologics manufacturing as well as associated quality and analytical issues is required.
• Ability to work in a highly matrixed team and to influence scientists and SMEs in other disciplines is required.
• Ability to work against tight timeline to meet business goal.
• Experience in biologics manufacturing process support and/or development, analytical development, or biologics process validation is needed.
• CMC development experience through IND and/or NDA/MAA.
• Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.
• Ability to influence internal and external experts on CMC regulatory issues, independently.
• Demonstrated excellence in writing, presentation, and overall communication.
• Demonstrated excellence in leading CMC project teams.

Nice To Haves

• Experience leading multiple CMC project teams through IND and NDA/MAA preferred.

Responsibilities

• Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners.
• Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial.
• Must present technical information regarding biologics manufacturing, process development and process characterization to management and to regulatory agencies.
• Prepare and review regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.
• Manage multiple projects at various stages of development.
• Represent assigned projects on the multidisciplinary Asset Development Team.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree