Sr. Manager/Manager, CMC Regulatory Affairs - South San Francisco, CA | Biospace
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Sr. Manager/Manager, CMC Regulatory Affairs

AbbVie Stemcentrx

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Location:
South San Francisco, CA
Posted Date:
8/17/2017
Position Type:
Full time
Job Code:
1705332
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.


AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots wor across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie’s South San Francisco, CA location.


As part of a talented and multi-disciplinary team advancing exciting new approaches to oncology drug discovery and development, AbbVie Stemcentrx is looking for a highly motivated CMC Sr. Manager or Manager. The successful candidate will be responsible for contributing to CMC strategies as well as coordinating many aspects of CMC regulatory submissions. This person will work closely with the development team, particularly with the Process Sciences (Formulation and Analytical Development), Manufacturing and Quality to define and contribute to the CMC role in all drug development programs for AbbVie Stemcentrx’s early pipeline programs.


Key Responsibilities:
  • Participates in or leads cross-functional product development teams, development of regulatory strategies and support for early development oncology development programs
  • Prepare, coordinate, review and maintain CMC content in regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSURs/annual reports, meeting packages, etc.), to ensure timelines are being met
  • Prepare technical assessments of CMC source documentation and responses to client technical questions on document content
  • Coordinate authoring/review/comment adjudication and finalization of CMC content and ensure document timelines are being met
  • Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs or other departments
  • Maintains knowledge of current CMC regulations/guidelines
  • Participates and contributes on project development teams in providing CMC regulatory guidance
  • Involved in preparation and supports CMC interactions with regulatory health authorities
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Requirements

Requirements:
  • Education: B.Sc. in Chemistry, Biology, Chemical Engineering or related field required , advanced degree preferred
  • 3-5 years of regulatory affairs CMC experience or a minimum of 5 years of technical development (analytical development, process development, or related) experience within the pharmaceutical industry
  • Prior experience as the SME or primary author for CMC sections in support of regulatory filings
  • Demonstrated knowledge of US and ICH biologic regulations related to CMC and biopharmaceutical product development
  • Understanding of API and drug product manufacture
  • Strong knowledge of current Good Manufacturing Practices (cGMP)
  • Strong computer skills including MS Word, Excel, PowerPoint, MS Project and Adobe Acrobat
  • Strong organizational skills in order to maintain a high level of communication, productivity, innovation, and priority-setting in order to work effectively in a dynamic environment to meet aggressive timelines.
  • Detail oriented with excellent oral and written communication skills, including scientific writing experience for effectively interfacing with all levels of management and departments within the company
  • Strong project management skills
  • Prior experience in ADCs and oncology is a plus