Job Description:The Vice President, Manufacturing & Engineering serves as a core executive leader within PDTO (Product Development Technical Operations), providing strategic, multi-disciplinary oversight across Xeris's entire outsourced manufacturing, supply chain, engineering, and quality control functions. Operating strictly within a contract manufacturing and testing ecosystem, this executive leads five distinct functional pillars: Commercial Manufacturing & Supply Chain Logistics, Manufacturing Science & Technology (MS&T), Process Innovation & Life Cycle Management, Device Development, and Quality Control (QC).
The primary mandate for this position is to ensure seamless integration and flawless execution across a highly diverse portfolio that spans small molecules, peptides, and biologics, in both oral solid and complex injectable dosage forms. The Vice President will guide products through the entire lifecycle continuum-from clinical development and process scale-up through commercial launch, combination product/device integration, and post-approval Life Cycle Management (LCM)-while ensuring uncompromising product quality and regulatory compliance.
Essential Job Functions- Executive Departmental Leadership: Provide strategic direction and executive management to five specialized functional leaders (Commercial Manufacturing, MS&T, Process Innovation & LCM, Device Development, and QC). Drive cross-functional alignment and eliminate operational silos across the department.
- Multi-Disciplinary Product Strategy: Direct overarching operational strategies for a diverse product portfolio (small molecules, peptides, biologics) across varied dosage forms (oral solids, advanced injectables) from clinical phases through commercialization and Life Cycle Management.
- Outsourced Network Governance: Serve as the senior executive sponsor for Xeris's global network of Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs). Establish and oversee strategies for vendor evaluation and selection, contract negotiations, capital expenditures, and vendor alliances to ensure capacity, quality, and financial efficiency.
- End-to-End Supply Chain Activities: Accountable for all aspects of Xeris's pharmaceutical supply chains ranging from raw materials to finished product inventories.
- Process Innovation & Life Cycle Management: Provide executive guidance and resource prioritization for complex, high-stakes technical initiatives, including the scale-up of novel formulation technologies (e.g., XeriJect) and commercial LCM projects (e.g., second sourcing, line extensions, etc.).
- Combination Product & Device Integration: Oversee the strategic intersection of Xeris's proprietary formulation platforms with advanced delivery devices, ensuring robust engineering frameworks, Design Controls, and seamless commercial execution.
- Quality Control & Compliance Governance: Ensure the QC department establishes and maintains rigorous, highly efficient and compliant testing, stability, and release frameworks that interface flawlessly with the independent Quality Assurance (QA) unit and external regulatory bodies.
- Regulatory Accountability: Maintain ultimate technical accountability for the manufacturing, device, and quality control sections of global regulatory submissions (INDs, IMPDs, NDAs, BLAs, MAAs) and lead technical strategy during Health Authority interactions and Pre-Approval Inspections (PAIs).
- Strategic Financial Management: Drive goal setting, capacity planning, and overarching budget development across all five functional pillars, aligning departmental spending with corporate profitability targets.
Skills and Qualifications- Bachelor's degree required, with a strong preference for Chemical Engineering. Degrees in Mechanical Engineering, Pharmaceutical Sciences, or related fields will be considered, commensurate with extensive, highly relevant operational experience. An advanced degree (M.S., Ph.D., or MBA) is strongly preferred.
- Minimum of 22+ years of experience in the pharmaceutical or biotechnology industry with a proven track record of executive leadership across manufacturing, engineering, and quality functions.
- Deep, hands-on expertise spanning a wide range of products (small molecules, peptides, biologics) and diverse dosage forms (oral solids, complex injectables).
- Comprehensive mastery of the drug development continuum, with proven success navigating clinical manufacturing, commercial process validation, combination product/device development, and post-approval Life Cycle Management.
- Demonstrated executive experience managing external/outsourced CMO and CTL networks globally.
- Strong technical understanding of cGMPs, Quality Control testing frameworks, FDA/EMA regulations, and global regulatory submission requirements.
- Exceptional executive presence, with the ability to manage complex internal team dynamics, mentor senior leaders, and communicate strategically with the Executive Management Team and external partners.
Working Conditions- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel may be required.
- This position is based in Xeris' Chicago Headquarters and requires a minimum of four days per week in the office. On-site requirements may change at management's discretion.
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The anticipated base salary range for this position is $279,200 - $418,800.
We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable.
The level of the position will be determined based on the selected candidate's qualifications and experience. Final determination of the actual base salary offered depends on several factors, including but not limited to the candidate's skills, experience, education, location, and business needs. Employees are eligible for equity or long-term incentive awards, where applicable. Field Sales role employees are eligible for a quarterly commission structure. Non-Sales role employees are eligible for an annual bonus. The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits and more for eligible employees. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. Individuals hired as temporary employees, interns, and preceptors are not eligible for commissions, bonuses, and/or long-term incentive or equity awards. Eligibility for other benefits will be based on plan documents.
Accessibility & Reasonable AccommodationsIf, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to [redacted] and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose, you will not receive a response to your email. Do not include any medical or health information in this email.
