AbbVieAB

Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) -Remote

AbbVie Inc. is a leading biopharmaceutical company specializing in drug development for complex health issues, headquartered in North Chicago, Illinois.

AbbVie

Employee count: 5000+

United States only

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

Purpose:

Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and by leading cross-functional CMC teams throughout Phase 1, Phase 2, and Phase 3 development

Responsibilities:

  • Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation.
  • Partner with subject matter experts in various process development functions to ensure technical information is accurately transcribed into regulatory documents.
  • Lead CMC teams in the development of robust control strategies and presentation of Control Strategy Reviews (CSRs)
  • Drive alignment with key business stakeholders including Product Development Directors, Development Sciences, and Quality Assurance and escalate issues to senior management when appropriate
  • Contribute on program acceleration and increased efficiency initiatives.

Qualifications

  • BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 8+ years of experience in the biopharmaceutical industry; MS and 6+ years experience; PhD and 3+ years experience.
  • Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development.
  • Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing.
  • Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.
  • High proficiency with Microsoft Word and Excel.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

  • This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

About the job

Apply before

Posted on

Job type

Full Time

Experience level

Senior

Location requirements

Hiring timezones

United States +/- 0 hours

About AbbVie

Learn more about AbbVie and their company culture.

View company profile

AbbVie Inc. is an American pharmaceutical company that was founded in 2013 after spinning off from Abbott Laboratories. The company is headquartered in North Chicago, Illinois, and has since established itself as one of the largest biomedical companies globally, ranking sixth in terms of revenue. AbbVie focuses on drug development with a mission to discover and deliver innovative medicines that effectively address complex health issues and enhance people's lives. Notable products from AbbVie include Humira, which has been a leading treatment for several autoimmune diseases, and Skyrizi, aimed at treating psoriasis and other chronic conditions.

As of 2024, the company employs approximately 50,000 people worldwide, demonstrating a strong commitment to research and innovation. AbbVie has made a name for itself in various therapeutic areas, including immunology, oncology, and neurology. With a legacy rooted in its parent company, Abbott, AbbVie aims to maintain its reputation for excellence by continuing to develop treatments that significantly improve patient outcomes and advances in healthcare.

Claim this profileAbbVie logoAB

AbbVie

Company size

5000+ employees

Founded in

2013

Chief executive officer

Robert A. Michael

Employees live in

View company profile

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