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Scientist II, CMC Sciences

Employer
AbbVie
Location
Worcester, Massachusetts
Start date
Sep 17, 2022

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Discipline
Science/R&D, Biotechnology, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

At AbbVie, we’re constantly finding new ways to address patients’ most serious health issues. We concentrate our efforts on a core set of therapeutic areas—ones where we’ve proven our expertise, and where we feel we can have an even greater impact on disease and how it is managed. To this end, we are looking to engage scientific talent to assist with the achievement of our organizational goals.

The CMC Scientist will independently author process validation documentation and process-related regulatory documentation. Provide technical input to validation-related activities to enable regulatory submission. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.    

Responsibilities:

  • Author process validation documentation, including process validation master plan, process performance qualification protocols and reports.
  • Author sections of regulatory documents, including INDs, BLAs, briefing packages and provide data support to regulatory inquiries.
  • Provide technical input to validation-related activities to enable robust regulatory submission, including areas of process development, process characterization, technical transfer and process validation.
  • Support process validation initiatives to ensure cross-functional alignment and improvement of validation workflows.
  • Apply process technical knowledge to support problem-solving during evaluation of process development data and validation.
  • Serve as a lead scientist within his/her own project and provide technical expertise on one or more project teams.
  • Contribute on program acceleration and increased efficiency initiatives.

Qualifications:

  • BS or equivalent education in Biochemistry or Chemical Engineering and 6+ years of experience; MS or equivalent education in Biochemistry or Chemical Engineering with 4+ years of experience
  • Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
  • Experienced supporting manufacturing process development activities, including process characterization studies, process scale-up, and technology transfer.
  • Experienced authoring validation documentation, validation activity support, and troubleshooting.
  • Demonstrated knowledge of scientific and regulatory requirements for implementation of post-approval process changes.
  • Demonstrated outstanding writing and technical communication skills, including experience authoring validation and regulatory documentation
  • Demonstrated ability to function as a lead scientist on his/her project, generating technical ideas and research or development strategies.


 

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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