Vice President, Manufacturing and Engineering

Xeris Pharmaceuticals•Chicago, IL

1d•Onsite

About The Position

The Vice President, Manufacturing & Engineering serves as a core executive leader within PDTO, providing strategic, multi-disciplinary oversight across Xeris’s entire outsourced manufacturing, supply chain, and device engineering functions. Operating strictly within a contract manufacturing ecosystem, this executive leads four distinct functional pillars: Commercial Manufacturing & Supply Chain Logistics, Manufacturing Science & Technology (MS&T), Process Innovation & Life Cycle Management, and Device Development. 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.

Requirements

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 and engineering 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 networks globally.
Strong technical understanding of cGMPs, 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.

Responsibilities

Provide strategic direction and executive management to four specialized functional leaders (Commercial Manufacturing, MS&T, Process Innovation & LCM, and Device Development). Drive cross-functional alignment and eliminate operational silos across the department.
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.
Serve as the senior executive sponsor for Xeris’s global network of Contract Manufacturing Organizations (CMOs). Establish and oversee strategies for vendor evaluation and selection, contract negotiations, capital expenditures, and vendor alliances to ensure capacity, quality, and financial efficiency.
Accountable for all aspects of Xeris’s pharmaceutical supply chains ranging from raw materials to finished product inventories.
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.).
Oversee the strategic intersection of Xeris’s proprietary formulation platforms with advanced delivery devices, ensuring robust engineering frameworks, Design Controls, and seamless commercial execution.
Maintain ultimate technical accountability for the manufacturing and device sections of global regulatory submissions (INDs, IMPDs, NDAs, BLAs, MAAs) and lead technical strategy during Health Authority interactions and Pre-Approval Inspections (PAIs).
Drive goal setting, capacity planning, and overarching budget development across all four functional pillars, aligning departmental spending with corporate profitability targets.