Senior Manager CMC Quality Control Writer - Tandym
Brisbane, CA
About the Job
We are seeking a highly motivated and experienced Quality Control Manager for a unique opportunity to join a biotech company focused on developing life transforming therapeutics for patients with rare diseases as the Manager/Senior Manager for CMC Quality Control Department.
Responsibilities:
The Senior Manager will be responsible for:
- All aspects of the QC data review for both commercial and clinical programs, including all modalities and molecules
- Working with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support the programs
- Collaborating closely with cross-functional departments to achieve corporate goals and objectives
- Playing an instrumental role in bringing the company's therapeutic products from early-discovery development stage to commercial launch and being a critical part of creating an innovation team for the development of the company's next generation products
- Being the analytical, technical, and quality operational subject matter expert (SME) for QC CMC writing, reviewing and assisting in Regulatory filings (ICH/Compendial/ FDA and EMA)
- Writing, updating and revising CMC stability sections in support of regulatory filings
- Addressing CMC stability inquiries per regulatory inquiries
- Performing 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:
- Participating in 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
- Working within QC and QA and other departments to address review comments on regulatory and QC/analytical documents
- Managing / Assisting the document creations and reviews via Veeva Document System
- Creating and updating batch analysis tables for release data
- Creating Excel/JMP tables and graphs/charts for release and stability data trending
- Initiation and management of change controls, deviations and CAPA with Veeva Document System
- Assisting in closing Quality Events/ Deviations (OOS/OOT/OOE) and Deviation Investigations
- Ensuring 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
- Evaluating 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
- Senior Quality Manager: 5 plus years' experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
- 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)
Desired Skills:
- Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA
- Good oral and written communication skills and a fast learner
- Working experience and knowledge in a wide variety of quality control release and stability methodologies
- 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
Source : Tandym
