Job Description:
- Seeking a highly motivated and experienced professional as Manager/Senior Manager for our external stability 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 aspects of the CMC QC program(s) support for commercial and clinical programs, including all modalities and all molecules. The Manager/Senior Manager will provide support to internal QC representors who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support of the quality control activities as assigned.
- The successful candidate will have a good understanding of cGMPs, ICH stability, 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 supporting the company’s therapeutic products from early-discovery development stage to commercial launch and be a critical part of innovation team for the development of the company’s next generation products. The individual in this role is expected to carry out all quality control activities in a strict regulated environment (ICH/Compendial/FDA and EMA).
Responsibilities including, but not limited to:
- Main focus: The Manager/Senior Manager of CMC QC will work across all products/programs as assigned (Clinical & Commercial products at West coast US) for quality control operational support
- External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing needs.
- Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products.
- Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
- Method Development and Validation: Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products.
- Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.
- QC data review: Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports
- Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
Other responsibilities may include:
- Work within QC and with QA and other departments to address review comments on QC/analytical documents
- Manage/assist the document creations and reviews via Veeva Document System
- Create and update batch analysis tables for stability data
- Keep track of contract lab stability time point pulls for different programs
- Create Excel/JMP tables and graphs for stability data trending
- Initiate and manage change controls, deviations and CAPA in Veeva Document System
- Assist in OOE/OOS/OOT investigations and deviations
- Ensure 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:
- Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
- Quality 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)
- Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirable
- Experience in conducting stability studies per ICH Guidelines 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)
On-Site: Senior Manager – CMC QC (234876)
