Vice President, Manufacturing and Engineering

Xeris Pharmaceuticals, Inc.; Chicago (IL); In loco; USD 279.000 - 419.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity awards

Long-term incentives

401(k) retirement benefits

Health, vision, and dental insurance

Paid time off

Annual bonus eligibility

Descrizione del lavoro

Xeris Pharmaceuticals, Inc. is seeking an accomplished Vice President, Manufacturing & Engineering to lead four pillars—Commercial Manufacturing, MS&T, Process Innovation & Life Cycle Management, and Device Development—within a strict contract manufacturing framework in a high-stakes environment.

The role covers products from clinical development through launch and post-approval lifecycle, ensuring quality and regulatory compliance.

Competenze

• Bachelor’s degree in engineering or related; advanced degree preferred.
• 22+ years in pharmaceutical/biotech with executive manufacturing/engineering experience.
• Experience across small molecules, peptides, biologics and dosage forms.
• Experience navigating clinical development through post-approval Life Cycle Management.
• Experience managing external/outsourced CMOs globally.
• Strong understanding of cGMPs and FDA/EMA regulations.
• Strong executive presence and strategic communication with executives and partners.

Mansioni

• Provide strategic leadership to four pillars: Commercial Manufacturing, MS&T, Process Innovation & LCM, and Device Development.
• Direct portfolio strategy from clinical phases to commercialization and Life Cycle Management.
• Oversee outsourced network governance with CMOs, vendor negotiations, capital expenditures, and alliances.
• Accountable for end-to-end supply chain activities from materials to finished goods.
• Guide scale-up of novel formulations and commercial LC projects and second sourcing.
• Oversee the integration of devices with formulations and Design Controls for robust execution.
• Maintain regulatory accountability for submissions and Health Authority interactions.
• Drive budgeting, capacity planning, and cross-functional alignment with profitability targets.

Conoscenze

Executive leadership

Global CMO management

Regulatory knowledge

Strategic planning

Cross-functional collaboration

Executive communication

Formazione

Bachelor’s degree

MS/PhD/MBA preferred

Descrizione del lavoro

Job Description

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 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.

Essential Job Functions

• Executive Departmental Leadership: 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.
• 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). 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.
• Regulatory Accountability: 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).
• Strategic Financial Management: Drive goal setting, capacity planning, and overarching budget development across all four 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 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.

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.

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.

Xeris Pharmaceuticals, Inc. (the “Company”) is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company’s employment selection decisions are based solely on job-related factors. NOTE: This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as needed to meet the ongoing needs of the Company.

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.

If, 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 [e-mail] 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.

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