Contractor, GMP Quality Assurance, Investigational
Syndax Pharmaceuticals is looking for a Contractor, GMP Quality Assurance - Investigational
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 lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). Throughout the process, ensure Syndax, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing, storage and distribution of products used for investigational clinical trials comply with cGMPs and standards established by company as well as regulations of applicable authorities.
Key Responsibilities:
• Support clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records.
• Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to support manufacturing and testing of materials supporting development of Syndax programs in a phase appropriate manner
• Manage and address associated investigations, CAPAs, change controls, OOS, etc.
• 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 and mitigate GMP activities and process improvement initiatives as requested by management.
• Work closely with Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems.
• 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.
• Minimum of 5 years of experience in the pharmaceutical industry, within GMP QA supporting contract manufacturing organizations
• Small molecule experience required (drug substance/API, drug product, packaging and labeling) including QC/analytical.
• Experience supporting clinical labeling/packaging activities, including QP release
• Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs.
• Experience working with external vendors and suppliers including, drug substance/API, drug product, analytical, and/or clinical packaging and labeling.
• Strong technical writing skills.
• Excellent communication skills.
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Ability to rapidly synthesize complex issues and identify risks in a pragmatic way.
Location: Syndax has an office in New York City and has a dispersed workforce across the United States.
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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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 lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). Throughout the process, ensure Syndax, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing, storage and distribution of products used for investigational clinical trials comply with cGMPs and standards established by company as well as regulations of applicable authorities.
Key Responsibilities:
• Support clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records.
• Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to support manufacturing and testing of materials supporting development of Syndax programs in a phase appropriate manner
• Manage and address associated investigations, CAPAs, change controls, OOS, etc.
• 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 and mitigate GMP activities and process improvement initiatives as requested by management.
• Work closely with Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems.
• 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.
• Minimum of 5 years of experience in the pharmaceutical industry, within GMP QA supporting contract manufacturing organizations
• Small molecule experience required (drug substance/API, drug product, packaging and labeling) including QC/analytical.
• Experience supporting clinical labeling/packaging activities, including QP release
• Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs.
• Experience working with external vendors and suppliers including, drug substance/API, drug product, analytical, and/or clinical packaging and labeling.
• Strong technical writing skills.
• Excellent communication skills.
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Ability to rapidly synthesize complex issues and identify risks in a pragmatic way.
Location: Syndax has an office in New York City and has a dispersed workforce across the United States.
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.
Apply tot his job
Apply To this Job