Description
Syndax Pharmaceuticals is looking for a Senior Manager, GMP Investigational Quality
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:
Responsible for GMP Quality oversight and lot review/release activities supporting early and late-stage phase investigational programs, including drug substance, drug product, and clinical finished goods manufactured, packaged, labeled, stored, and distributed by Contract Manufacturing Organizations (CMOs) and other external partners. Throughout the process, ensure Syndax, its affiliates, and/or CMOs comply with cGMPs, Syndax Quality Systems, and applicable regulatory requirements.
Key Responsibilities:
- Support GMP Quality oversight for early phase investigational programs, including review and approval of master batch records, executed batch records, certificates of analysis, specifications, method qualification protocols/reports, and supporting source documentation for drug substance, drug product, and clinical finished goods.
- Support clinical finished goods release activities, including review of packaging and labeling records, label proofs, expiry/retest information, temperature excursion documentation, and product release, including QP release support.
- Effectively interact with external contract manufacturers, CDMOs, contract laboratories, packaging and labeling vendors, and internal cross-functional partners to support manufacturing, testing, packaging, labeling, storage, and distribution of materials for Syndax development programs.
- Manage and address associated deviations, investigations, CAPAs, change controls, OOS/OOT events, product complaints, and other quality events with a focus on product impact, patient safety, data integrity, and clinical supply continuity.
- Lead investigations into quality issues; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions to closure and confirm effectiveness.
- Partner with CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external partners to identify GMP risks, resolve quality issues, and support timely execution of early phase clinical supply activities.
- Identify and mitigate GMP compliance risks, quality system gaps, and process improvement opportunities related to early development, investigational material release, and clinical finished goods operations.
- Work closely with the Quality Assurance team to ensure alignment with Syndax Quality Systems, including consistent application of procedures, documentation standards, and risk-based decision making.
- Author, review, and/or approve GMP quality documents, including deviations, change controls, CAPAs, SOPs, and quality agreements, as applicable.
- Maintain clear communication of quality risks, open issues, release readiness, and clinical supply support activities.
- Operate independently with guidance from manager and senior staff; demonstrate sound judgment, ownership, and the ability to articulate complex GMP issues clearly verbally and in writing.
Desired Experience/Education and Personal Attributes:
- BS degree in a scientific field required.
- Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with GMP Quality experience supporting contract manufacturing organizations and clinical-stage development programs.
- Experience supporting early phase clinical programs, including GMP oversight of drug substance, drug product, and/or clinical finished goods manufacturing, packaging, labeling, storage, and distribution activities.
- Experience reviewing and approving master batch records, executed batch records, clinical packaging and labeling records, certificates of analysis, method qualification protocols/reports, and other GMP documentation.
- Experience supporting clinical labeling and packaging activities, clinical finished goods release, expiry/retest dating, temperature excursion assessment, and QP release activities.
- Experience managing or supporting deviations, investigations, CAPAs, change controls, OOS/OOT events, complaints, and product impact assessments in a GMP environment.
- Must have experience working in cross-functional teams, including CMC, Analytical Development, Supply Chain, Clinical Operations, Regulatory Affairs, and external vendors or suppliers.
- Strong technical writing skills and ability to translate complex GMP issues into clear, inspection-ready documentation.
- Excellent communication skills with the ability to collaborate effectively across internal teams and external partners.
- Strong judgment, project management, and decision-making skills; able to manage multiple projects, competing priorities, and demanding clinical supply timelines.
- Ability to rapidly synthesize complex issues, identify compliance and patient safety risks, and apply pragmatic, risk-based solutions.
- Self-motivated, independent, and comfortable operating in a fast-paced, fully outsourced or hybrid outsourced manufacturing environment.
Location: Syndax’s corporate office is in New York, NY.
Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $175,000 -$192,000.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. 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 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.
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