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Senior Manager, Clinical Product Supply (CMC)

Employer
AbbVie
Location
Lake County, IL, US
Start date
Sep 21, 2019

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Discipline
Clinical, Clinical Research, Marketing
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

The Senior Manager, Clinical Product Supply (CMC) is primarily responsible for ensuring the successful and timely release of Good Manufacturing Practice (GMP) clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes from drug substance to drug product to finished product

Key Responsibilities Include :

  • Serve as the quality assurance (QA) point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of drug to clinical trials to meet project timelines.
  • Provide management of clinical supply product actions and recalls.
  • Support in-licensing and collaboration activities.
  • Ensure suitable quality agreements or quality aspects of contracts are in place between Research and Development (R&D) and third party manufacturers, third party laboratories, other service providers and other sites.
  • Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits.
  • Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers.
  • Provide consultation & training on QA specific items to internal and cross-functional groups
  • Lead complex global cross-functional process improvement teams.
  • Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight.
  • Review and approve extemporaneous dose preparation instructions.


Basic:
  • Bachelor's degree or equivalent experience is required; typically in life sciences, engineering
  • Minimum 6+ years of industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree
  • Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide requirements for GMP is required.
  • Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies as they apply to the clinical pharmaceutical and chemical manufacturing processes.
  • Good communications skills
  • Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
  • Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment.

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

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
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