Vice President, Manufacturing and Engineering
$279.2k - $418.8kXeris Pharmaceuticals
Job Description:
The Vice President Manufacturing & Engineering serves as a core executive leader within PDTO providing strategic multi-disciplinary oversight across Xeriss 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 continuumfrom 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 Xeriss 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 Xeriss 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 Xeriss 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
- Bachelors 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 managements discretion.
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Theanticipatedbase salary range for this position is $279200 - $418800.
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 Companys employment selection decisions are based solely on job-related : 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 candidates qualifications and experience. Final determination of the actual base salary offered depends on several factors including but not limited to the candidates 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 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 Accommodations
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 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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Required Experience:
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$279.2k - $418.8k
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