Manager, Commercial & Clinical Packaging

Overview

The Manager, Commercial and Clinical Packaging is responsible for the hands-on management of all Contract Packaging Organizations (CPO) and related activities.  This is a key role within Supply Chain and requires expertise in commercial and clinical packaging, packaging components, artwork management, relationship management, general project management, risk management, and key performance metrics management. This position will also work with other members of CMC, Product Development, Supply Chain Operations and Quality Assurance to develop and maintain contract packaging solutions for all Xeris products.

Responsibilities

• Manage CPO partnerships and all packaging related activity
• In conjunction with QA & QC, ensure compliance with Xeris SOP’s, GMPs and all state and federal regulations
• Lead all packaging development activities including CPO line trials, OQ’s and PQ’s; responsible for the development and execution of all protocols and validation plans; lead equipment selection and implementation at CPO’s as required
• Participate in internal planning processes to ensure alignment on production requirements at CPOs
• In conjunction with Supply Chain, manage CPO forecasts and POs within contractual lead times, to procure services and materials based on firm demand
• Monitor status of work in progress to ensure on-time delivery to meet requirements and/or address impact of any delays or other schedule changes; provide direction and prioritization for such changes to the CRO and communicate any potential issues to Xeris Management
• Review packaging batch records and ensure timely release in conjunction with QA
• Lead quarterly business reviews with CPOs to ensure they have the capacity to meet future requirements; review performance, address ongoing issues, initiate process improvement or cost reduction initiatives
• In conjunction with Supply Chain and QA, manage all component and graphic changes with CPO’s including implementation timelines, artwork development, vendor proof approval, material specifications, BOM’s, and inventory obsolescence/destruction, and serialization
• Lead / manage all ASTM handling studies and validation of shipping containers and lanes assuring that all shipments comply with validated processes
• Drive start-up of new CPO’s as required
• Develop, maintain and optimize contracts with CPO’s
• Participate in cross-functional project teams as required and support new packaging development activities for pipeline products

Qualifications

• Bachelor’s degree in Packaging Engineering or Mechanical Engineering
• 3-5 years of experience in a GMP manufacturing environment with hands on contract manufacturing or packaging management experience within the life sciences industry.
• Ability to work effectively with cross-functional and multi-location teams requiring large-scale coordination.
• Ability to influence and drive business performance through establishment and management of key performance metrics.
• Ability to identify and facilitate business risk/issue mitigation and resolution.
• Effectively manages projects in a fast-paced environment, meeting strict deadlines while maintaining quality standards.
• Ideal candidate will have experience managing 3rd party providers, complex projects and effective at communicating with internal and external stakeholders at all levels.
• Exhibit creatively in adapting to situations, developing contingency plans, and making decisions.
• Familiarity with Manufacturing and Supply Contracts.
• Project Management and Supply Chain experience a plus.
• Competencies:  Customer Service focus, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications.
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. Ability to travel up to 25% domestically. This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.

#LI-HYBRID

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.

The anticipated base salary range for this position is $100,000 to $130,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. 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.  

NOTE:  This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Salary : $100,000 - $130,000