Job description
Syndax Pharmaceuticals is looking for a Contractor, GMP Quality Assurance, Commercial
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
The Contractor, Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all Syndax commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions, risk mitigation. They will have responsibility for the daily commercial GMP operations at Syndax CMOs, including responsibility for Syndax’ quality management system and ensuring internal systems follow GMPs and Company policies and procedures. They will work with internal functions and external vendors to promote a high level of quality. They will support a company-wide culture of sustainable GMP and Quality compliance. This role is a contract position.
Key Responsibilities:
- Review and approve GMP batch records and associated documentation
- Support CMC with review of CMO documents including, specifications, methods, labeling, batch records, analytical testing, stability documents, COA/COC for commercial product.
- Support validation efforts of new vendors for drug product, drug substance, and packaging/labeling of commercial product
- Support investigations into quality issues with focus on product impact and patient safety; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
- Identify process improvement initiatives as requested by management.
- Work closely with Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems.
- Support Quality Operations and Quality Systems tasks, as required
- Self-motivating and independent.
- Work independently with guidance from manager and senior staff.
- Must be able to articulate complex issues clearly verbally and written.
- Author, review, and/or approval documents including deviations, SOPs, and protocols.
Desired Experience/Education and Personal Attributes:
- BS degree in scientific field required, advanced degree preferred.
- Minimum of 2-4 years of experience in the pharmaceutical industry, including release of commercial product, within QA/GMP environment.
- Small molecule experience required (drug substance/API, drug product, packaging and labeling) and QC/analytical.
- Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs, medical affairs, and commercial.
- Experience working with external vendors and suppliers including, drug substance/API, drug product, analytical, and/or secondary packaging and labeling.
- Awareness of 21 CFR 210⁄211 and Part 11, ICH GMP, and applicable global regulations.
- Strong technical writing skills.
- Excellent communication skills.
- Strong judgment, project management and decision-making skills; able to manage multiple priorities and demanding timelines.
Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company’s pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
#LI-Remote
