This role will support manufacturing technical operations with technical oversight of multiple drug product contractors to ensure delivery of clinical and commercial supplies. This position will support external operations at multiple Contract Organizations (CMOs, CDMOs) associated with Xeris commercial and pipeline products and activities. This includes on-site person-in-plant oversight of manufacturing activities during technology transfers, process scale-up, process validations, and other manufacturing operations. Provide CMC knowledge and technical support regarding the company’s due diligence and regulatory submission documents. Leverage technical skills (chemistry/engineering, GMP regulation, risk evaluations, drug development), business skills (project management, finance), and soft skills (vendor engagement, relationship building) to provide strategic input for program core teams and budgets. Proactively collaborate with other Technical Operations functional areas regarding relevant cross-functional activities on a routine basis, e.g., Product Development, Supply Chain, Logistics, Packaging, Device, CMC, Quality Control, Quality Assurance, Regulatory. Manage and track departmental schedules to meet operational targets. Proactively support the generation and protection of the company’s intellectual property and maintain awareness of current industry trends and practices.
Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
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