GMP Quality Assurance - Development

Summary

Join Syndax Pharmaceuticals as a Contractor, GMP Quality Assurance, Development and contribute to the development of innovative cancer therapies. You will be responsible for lot review and release activities for drug substances, drug products, and finished goods. This role involves ensuring compliance with cGMPs and relevant regulations. Key responsibilities include supporting clinical product release, interacting with external manufacturers and laboratories, managing investigations and CAPAs, and identifying GMP process improvements. The ideal candidate will have a BS degree in a scientific field, at least 5 years of pharmaceutical industry experience in GMP QA supporting contract manufacturing organizations, and experience with small molecule drug substances and products. The position offers the flexibility of remote work.

Requirements

• 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

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

Benefits

#LI-Remote