Manager/Sr. Manager, CMC QC Writer and Reviewer - The Steely Group

Our client is seeking a highly motivated and experienced professional as Manager/Senior Manager for CMC Quality Control department, with the passion and creativity to support 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 the commercial and clinical programs, including all modalities, and all 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 company 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 be a critical part of creating an innovation team for the development of the company’s next generation products.  The individual in this role will be the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, review and assist in Regulatory filings (ICH/Compendial/FDA and EMA).

Responsibilities:

• Main Focus: 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 for one or more programs
• 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
• Other responsibilities may include: 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 creations 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 GMP’s 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 / Qualifications:

• 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 plus years’ experience with 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)