Director, ADC CMC Sciences

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, Xand You Tube.

Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG group.

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 Abb Vie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial.
• Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of impact on Operations.
• Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to management and regulatory agencies.
• Review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for submissions.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)
• Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.
• Develop new and less experienced CMC leads through sponsor/mentor relationships.
• Identify and promote best practices among S&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

• Bachelor ’s Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development);
  Master’s Degree with 14+ years of relevant experience;
  PhD Degree with at least 12+ years of relevant experience.
• 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.
• Demonstrated ability to provide strategic direction for work groups, departments, etc.

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

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.
  
  Individual compensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• 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 toparticipatein our long-term incentive programs.

Note:

No amount of payis considered to bewages 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 employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more: