Senior Manager, Cmc Qc

Description:

Job DescriptionJob Description
Our client is seeking a highly motivated and experienced professional as Manager/Senior Manager for our clinical and commercial programs in the CMC Quality Control Department, West Coast, US, 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 CMC QC Program support for the client's biological programs. The Manager/Senior Manager also will provide support to internal QC representatives who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality and industrial standards are met to support of the quality control activities as assigned.
The successful candidate will have a good understanding of biologics drug substance processes, analytical methodologies, cGMPs, ICH guidelines, 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 and ultra rare diseases. This position will be instrumental in supporting the company’s therapeutic products from development stage to commercial launch and be a critical part of an innovation team for the development of the company’s next products.
The individual in this role is expected to carry out all quality control activities in a strict regulated GMP environment (ICH/USP and Ph. Eur. Compendial/FDA and EMA).
Responsibilities
The Manager/Senior Manager of CMC QC will work across the biological products/programs as assigned (Clinical & Commercial products at West Coast US) for quality control operational support:Method Development, Validation, and transfer: Support the development, validation, and transfer of analytical methods used for QC testing of biologics, small molecule and oligonucleotide products.QC data review: Manage, review, and organize Release/stability, method validation/transfer data from active stability programs and generate interim stability trending assessments and reportsExternal Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing for release/stability and method validation/transfer needs.Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, method validation/transfer and release/stability activities, of Biologics.Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelinesOther responsibilities may include:Work within QC and with QA and other departments to address review comments on QC/analytical documentsManage/assist the document creations and reviews via Veeva Document SystemCreate and update batch analysis tables for stability dataKeep track of contract lab stability time point pulls for different programsCreate Excel/JMP tables and graphs for stability data trendingInitiate and manage change controls, deviations and CAPA in Veeva Document SystemAssist in OOE/OOS/OOT investigations and deviationsEnsure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support release and stability testing
Requirements / Qualifications
Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science fieldQuality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)Experience with a good understanding of biologics drug substance processes; encompassing the initial cell culture and production phases (upstream), as well as the subsequent purification and isolation steps to create the final drug substance (downstream).Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirableExperience in conducting stability studies per ICH Guidelines is highly desirable.Good oral and written communication skills and a fast learnerProficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlinesProficiency in MS Office, Word and ExcelProficient in statistical analysis software desired (Excel/JMP)
Company DescriptionThe Steely Group is a preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.