Senior Manager, Pharmaceutical Manufacturing

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:

• Provide technical operations expertise in the areas of aseptic fill/finish and tech transfer of drug product
• Responsible for a wide range of activities such as project management associated to the execution of clinical / commercial drug product manufacturing
• Support and manage the day-to-day manufacturing activities to ensure drug product clinical and commercial supply
• Direct interaction with contract site management, includes being on-site at CMOs and hands-on person-in-plant oversight activities
• Technical review of Engineering and GMP batch records, draft and executed validation protocols and reports, work instructions, SOPs, or other required documents for cGMP operations
• Helps with logistics and planning activities such as proposals, quotes, invoices, and shipping
• Frequently interacts with other functional peer group managers and CMOs to support the development or manufacturing activities
• Support the operations within the Technical Operations Department such as production planning, scheduling, and inventory management.
• Support any routine and nonroutine cGMP activities, deviations, investigations, CAPAs, process improvements, change control technical assessment, shelf-life extensions, etc.
• Ensure business objectives while meeting quality and compliance standards
• Collaborate with other departments on any DOE or QbD activities
• Track invoice approvals and proactively verify versus work performed.

• Bachelor’s/Master’s degree required in relevant Life Sciences, Scientific, Pharmaceutical Sciences, Pharmaceutical Engineer, Chemical Engineer, or related field
• Minimum 7+ of experience in a GMP global pharmaceutical / biotech environment with sterile drug product manufacturing and development
• Experience with peptides, small molecules, biologicals, and aseptic processes
• Knowledge of cGMP regulations for process validation and continuous improvement programs
• Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and managing third party CMO relationships
• Must have strong computer skills, including all MS Office applications
• Competencies: Strong Project Management skills, Leadership skills, Team Oriented, Self-directed, Multi-tasker, Attention to Detail, Interpersonal skills, Written and Verbal Communication, Negotiation, Problem-Solving, Time Management, and Organizational skills
•  Working Conditions: Position may require periodic evening / weekend work, and periodic overnight travel, as necessary to fulfill obligations. Travel may be required up to 25% at times to CMOs locations.

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.