Associate Director, CMC-Pharma Product Group

Company Description

About AbbVie

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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Position will be responsible for CMC leadership and project management for existing and new biologics projects from the drug substance perspective.

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.

Qualifications

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• 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. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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