Associate Director, CMC-Pharma Product Group

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 locationand 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 commissionincentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless anduntil paid and may be modified at the Companys 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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Work :

No

Employment Type :

Full-time