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Senior Manager CMC QC Writer and Reviewer
4 weeks ago
We are seeking a highly motivated and experienced professional for the Manager/Senior Manager role in the CMC Quality Control department, with the passion and creativity to support the development of great medicines for rare and ultra-rare diseases.
The Manager/Senior Manager will be responsible for all aspects of QC data review for commercial and clinical programs, including all modalities and molecules. The Manager/Senior Manager will work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support the programs. This position will collaborate closely with cross-functional departments to achieve corporate goals and objectives.
The successful candidate will have a good understanding of cGMPs, ICH, and regulatory drug requirements, be a self-starter with the ability to work under limited supervision, and have the desire to be part of an innovative team.
This is a unique opportunity to join a biotech company focused on developing life-transforming therapeutics for patients with rare diseases. This position will be instrumental in bringing the company’s therapeutic products from early-discovery development stage to commercial launch and will be a critical part of creating an innovation team for the development of the company’s next-generation products.
Responsibilities:
MUST HAVES:
- The CMC QC Manager/Senior Manager will author, draft, review, and approve the Regulatory QC CMC sections of our IND/IMPD and BLA/NDA filings.
- Author, update, and revise CMC stability sections in support of regulatory filings.
- Address CMC stability inquiries per regulatory inquiries.
- Perform review/draft of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports, and other QC/analytical documents.
ADDITIONAL RESPONSIBILITIES:
Participate in the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.
- Generate QC documents including, but not limited to, CoAs, reference standard qualifications and reports, and risk assessments.
- Work within QC and with QA and other departments to address review comments on regulatory and QC/analytical documents.
- Manage/assist the document creation and reviews via Veeva Document System.
- Create and update batch analysis tables for release data.
- Create Excel/JMP tables and graphs/charts for release and stability data trending.
- Initiate and manage change controls, deviations, and CAPA with Veeva Document System.
- Assist in closing Quality events/Deviations (OOS/OOT/OOE) and Deviation investigations.
- Ensure compliance with current GMPs in a manufacturing environment such that the products are assessed to agree upon specifications in a timely manner in order to support lot release and stability testing.
- Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.
Requirements:
- Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related life science field.
- Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA, is highly desirable.
- Senior Quality Manager: 5+ years of analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries).
- Working experience and knowledge in a wide variety of quality control release and stability methodologies is highly desirable.
- Good oral and written communication skills and a fast learner.
- Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with tight deadlines.
- Proficiency in MS Office, Word, and Excel.
- Proficient in statistical analysis software desired (Excel/JMP).
