3 Jobs in Brisbane, CA
Green Key Resources is Hiring a CMC Project Manager Near Brisbane, CA
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
- The Manager/Senior Manager of CMC QC will work across all client 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
- 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
- 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)
Job Summary
Full Time
Ambulatory Healthcare Services
$126k-161k (estimate)
06/22/2024
08/06/2024
greenkeyllc.com
POTOMAC, MD
500 - 1,000
2004
CHELSEA MURPHY
<$5M
Ambulatory Healthcare Services
Related Companies
The job skills required for CMC Project Manager include Analysis, Written Communication, Innovation, Organizational Skills, Quality Control, Program Management, etc. Having related job skills and expertise will give you an advantage when applying to be a CMC Project Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by CMC Project Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for CMC Project Manager positions, which can be used as a reference in future career path planning. As a CMC Project Manager, it can be promoted into senior positions as a Planner/Scheduler IV - Construction that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary CMC Project Manager. You can explore the career advancement for a CMC Project Manager below and select your interested title to get hiring information.
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