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Senior CMC Quality Control Manager
2 months ago
We are looking for a dedicated and skilled individual to fill the role of Senior Manager in the CMC Quality Control division, driven by a commitment to advancing innovative therapies for rare and ultra-rare conditions.
The Senior Manager will oversee all facets of Quality Control data evaluation for both commercial and clinical initiatives, encompassing various modalities and compounds. This role will involve collaboration with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure compliance with necessary quality benchmarks to support ongoing programs. The successful candidate will work closely with cross-functional teams to fulfill corporate objectives.
The ideal candidate will possess a solid grasp of current Good Manufacturing Practices (cGMPs), International Council for Harmonisation (ICH) guidelines, and regulatory requirements for pharmaceuticals. They should be a proactive individual capable of working independently and eager to contribute to a pioneering team.
This position presents a distinctive opportunity to be part of a biotech firm dedicated to developing transformative treatments for patients with rare diseases. The role will be crucial in transitioning the company's therapeutic products from early-stage development to market launch and will play a vital part in establishing an innovative team focused on the next generation of products.
Key Responsibilities:
Essential Duties:
- The CMC QC Senior Manager will be responsible for authoring, drafting, reviewing, and approving the Regulatory QC CMC sections of our IND/IMPD and BLA/NDA submissions.
- Develop, update, and modify CMC stability sections to support regulatory submissions.
- Address inquiries related to CMC stability as per regulatory requests.
- Conduct reviews and drafts of analytical release and stability data, ensuring data integrity, laboratory documentation, stability reports, specifications, and other QC/analytical documents are accurate.
Additional Responsibilities:
Engage in the qualification and validation of analytical testing methods for all Product Quality parameters, specification setting, and stability programs for both clinical and commercial products in alignment with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.
- Generate QC documentation, including Certificates of Analysis (CoAs), reference standard qualifications, and risk assessments.
- Collaborate with QC, QA, and other departments to address feedback on regulatory and QC/analytical documents.
- Assist in the creation and review of documents using the Veeva Document System.
- Compile and update batch analysis tables for release data.
- Create Excel/JMP tables and graphs/charts for trending release and stability data.
- Initiate and manage change controls, deviations, and Corrective and Preventive Actions (CAPA) using the Veeva Document System.
- Support the resolution of Quality events/Deviations (OOS/OOT/OOE) and conduct Deviation investigations.
- Ensure adherence to current GMPs in a manufacturing context, ensuring products meet agreed specifications promptly to facilitate lot release and stability testing.
- Review existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.
Qualifications:
- Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related life science discipline.
- Experience in drafting and reviewing CMC submissions for regulatory purposes, including IND/IMPD, BLA, and/or MAA, is highly advantageous.
- Senior Quality Manager: A minimum of 5 years of analytical/QC experience in a GMP setting (Pharmaceutical or Biotech sectors).
- Familiarity with a diverse range of quality control release and stability methodologies is highly preferred.
- Strong verbal and written communication skills and a quick learner.
- Proficient in project and personnel management, with excellent organizational skills and the ability to manage multiple projects under tight deadlines.
- Proficiency in MS Office, particularly Word and Excel.
- Experience with statistical analysis software is desirable (Excel/JMP).
