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Director, Biologics Analytical R&D

Employer
AbbVie
Location
Irvine, California
Start date
Sep 25, 2022
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Job Details

Overview:

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products.  Our scope spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support process performance qualification (PPQ) and product launch.  We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.  Careers in AbbVie Biologics Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.  We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Biologics Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

 

Position Description:

For the Biologics Analytical R&D Director position, we are seeking a highly motivated, experienced analytical scientist and leader to lead a diverse team of Ph.D., M.S. and B.S. analytical scientists supporting the development of therapeutic biologics from early development through commercialization, with a specific focus on neurotoxins for therapeutics and aesthetics use.  The candidate should have extensive expertise in the development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, and analytical understanding for drug substance and drug product process development, scale up and technology transfer.  He/she will lead a team that includes analytical project leads who represent global Biologics Analytical R&D on cross-functional Chemistry Manufacturing & Control (CMC) teams and are responsible for all analytical program decisions and deliverables to support program advancement through clinical development to commercial launch.  The candidate should have experience with submission and approval of Clinical Trial Applications (INDs, IMPDs, etc.) and Marketing Applications (BLAs, MAAs, etc.) for therapeutic biologics.  He/she must be able to mentor and develop scientists across a range of different experience levels and must foster productive collaborations within the global Biologics Analytical R&D organization and with R&D cross-functional partners and across functions such as Discovery Research, Operations, Quality Assurance and Science & Technology (S&T). 

Responsibilities

  • Lead a team of analytical team leaders and scientists working with cross functional R&D partners to develop therapeutic biologic candidates from early development through NDA approval and launch.
  • Mentor analytical leads and scientists on the development of phase-appropriate analytical strategies such as analytical method development, product specifications, stability and comparability to support process and formulation changes involving Drug Substance and Drug Product.
  • Collaborate across Biologics Analytical R&D and partner functions to define analytical and CMC strategies that improve the efficiency and effectiveness of the organization and help position Biologics Analytical R&D as an industry leader relative to peer companies in terms of our science and product development capabilities.
  • Form strong alliances with partner functions such as Science & Technology (S&T) and QC Operations to ensure robust and effective analytical method transfers and control strategy implementation. 
  • Review and edit key regulatory documents, technical reports and analytical method packages to drive high quality, fit-for-purpose regulatory submissions and source reports. 
  • Recruit and develop top talent to create and maintain a productive team of highly skilled scientists and project leaders.  Establish and maintain an environment that ensures retention of key talent through continued development opportunities and recognition of key accomplishments. 
  • Encourage ideas and drive for continuous improvement and champion initiatives within the Analytical R&D organization and across R&D partner functions.  Evaluate and recommend new technologies for application in the development, manufacture and testing of therapeutic biologics products.
  • Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.

Basic:

  • Ph.D. or Master’s Degree with at least 8 years of related industry experience preferred or  Bachelor’s Degree with at least 12 years of related industry experience required.  Advanced degree in Analytical Chemistry preferred.
  • A minimum of 6 years of experience in the management of scientists and technical programs, including technical, financial and performance management responsibilities.
  • Strong technical background in analytical chemistry is required; including direct experience with analytical technologies used routinely in the pharmaceutical and biotech industries
  • Experience must include leadership of analytical development programs for therapeutic biologic candidates across the early- and late-stages of clinical development and participation on cross-functional CMC development teams 
  • Demonstrated capability to solve critical scientific and business problems
  • Demonstrated ability to implement and to grow the capabilities of an analytical organization and develop scientists into future leaders
  • Extensive experience in drug substance and drug product process development for biologic products including: scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories
  • Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S. and OUS

This position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.  AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Find Us
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
United States
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