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

AbbVie • Worcester, MA

250d

About The Position

Position will be responsible for ownership of digital systems and data management strategies for biologics drug substance within Product Development Science and Technology.

Requirements

• B.S., M.S., and/or Ph.D. in biochemistry, biology, chemical engineering, computer engineering/science, data science or related field.
• 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.
• Ability to work against tight timelines to meet business goals.

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.
• Partner closely with process scientists, engineers, and statisticians to define data flows within the CMC organization.
• Partner closely with Abbvie Business Data Systems/IT to deploy new digital systems.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree