Associate Director, Program Management CMC Biologics ( On-site)

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Position will be responsible for ownership of digital systems and data management

strategies for biologics drug substance within Product Development Science and

Technology.

Responsibilities:

• Lead implementation of work processes to eliminate manual data manipulation and

  drive efficiencies in data aggregation/visualization with the aim of streamlining

  IND/BLA authoring. This includes, but is not limited to:

  o Partner closely with process scientists, engineers, and statisticians to define

  data flows within the CMC organization.

  o Partner closely with Abbvie Business Data Systems/IT to deploy new digital

  systems.

  o Partner closely with Quality Assurance to ensure Biologics CMC data integrity

  practices are best in class.

• Serve as business area owner for various data and lab systems (eg PI, NuGenesis,

  IDBS)

• Interactions with regulatory authorities (FDA, EMA) may be required.

• Stay current with industry best practices and benchmark against Abbvie peer

  companies

Qualifications

• B.S., M.S., and/or Ph.D. in biochemistry, biology, chemical engineering, computer engineering/science, data science or related field with 10+ years of industrial experience. Experience in biotechnology or biopharmaceutical development is preferred.
• 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.
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