AbbVie

Principal Research Scientist - Process Validation and Process Regulatory Strategy

Employer
AbbVie
Location
Worcester, MA, United States
Posted
Oct 26, 2020
Ref
2007085
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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 , YouTube and LinkedIn .

Purpose:

Direct and lead process validation activities and guide strategy for process development to support regulatory approval of biologics. Independently author process-related regulatory documentation. Direct project activities by effectively guiding scientific personnel. Independently conceive, execute, and communicate novel ideas to improve process development and validation strategy to achieve project and area goals. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.

Responsibilities:
  • Direct and lead process validation activities, including strategy development and validation documentation.
  • Guide process development strategy for internal programs and external collaborations to ensure cross-functional alignment and delivery of comprehensive development package.
  • Primary author of regulatory documents, including INDs, BLAs, briefing packages, and responses to regulatory inquiries.
  • Manage and drive project timelines to ensure successful process validation.
  • Apply manufacturing process technical knowledge to support problem-solving during process development and validation.
  • Guide and mentor scientific personnel to support area goals and team development.
  • Effectively function as a principal investigator, generating original technical ideas and research or development strategies.
  • Independently responsible for project science within his/her area of expertise on one or more project teams.
  • Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.

Qualifications

Qualifications:
  • BS or equivalent education in Chemical Engineering and 15+ years of experience; MS or equivalent education in Chemical Engineering with 12+ years of experience; PhD in Chemical Engineering with 6+ years of experience.
  • Experience leading and guiding process validation activities including development of validation strategy, authoring of validation documentation, validation activity support, and troubleshooting.
  • Demonstrated broad knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development from early development through commercialization.
  • Experience leading biologics manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
  • Demonstrated knowledge of scientific and regulatory requirements for implementation of post-approval process changes.
  • Project management experience and demonstrated ability to lead and manage cross-functional initiatives in support of process development and validation, both internally and through external collaborations.
  • Demonstrated outstanding writing and technical communication skills, including experience authoring validation and regulatory documentation and successful authoring of responses to regulatory questions.
  • Demonstrated ability to function as a principal investigator, generating original technical ideas and research or development strategies.
  • Demonstrated creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.