Pharmaceutical Software Developer Jobs in Geneva, IL

Job Description:

The Executive Director, Device Development is responsible for providing executive level, strategic oversight of Xeris' combination product and device development function. This role will manage the intersection of our proprietary XeriSol and XeriJect technology platforms with the advanced delivery systems required to provide Xeris' highly optimized combination products. The Executive Director will assume strategic and operational leadership over all combination product commercial and development functions, bridging critical cross-functional gaps between engineering, clinical, quality, regulatory, and commercial functions to ensure our combination products hit key program milestones. This position is vital to optimizing department resource management, accelerating communication protocols, and ensuring strict deadline adherence on highly visible corporate projects. The position will directly manage existing device engineering resources, elevating the function by instituting rigorous work-organization frameworks and proactive data-sharing across CMC, clinical, quality, and regulatory stakeholders.

The Executive Director is responsible for development of products according to Xeris' Design Controls and Quality By Design (QbD) development processes. Program work will include all aspects of drug delivery and associated container/closure system development. While Xeris may use partners to co-develop combination products, the Executive Director will manage these business relationships and ensure Xeris' goals and objectives are met. The Executive Director is also responsible for ensuring the accurate and timely compilation of the relevant Regulatory CMC Module sections, Device History File (DHF), Quality Target Product Profile, specifications and support for associated submissions.

Essential Job Functions

• Establish the strategies for the design and development activities for new and existing drug/device products to ensure they meet quality, regulatory and internal Xeris standards
• Develop, lead, and retain a high-performing device engineering organization by attracting top talent, fostering employee engagement and professional growth, building leadership capability, and creating an inclusive, accountable culture that enables exceptional technical execution and program success.
• Remain current on applicable regulations, guidances and standards that drive Xeris' combination products programs.
• Represent the drug delivery function at an executive level on cross-functional development and commercial teams as well as meetings with external partners
• Provide oversight in determining the technical design criteria for each program
• Provide oversight of all drug delivery development and commercialization aspects for Xeris' combination products
• Oversee translation of product requirements into specifications
• Manage and oversee device design development in accordance with specifications and applicable guidelines/regulations
• Ensure the robustness of new products through product launch
• Establish strategies and provide expert level input to development teams for pre- and post- commercial manufacturing
• Oversee the work of cross-functional teams to solve complex combination product related issues
• Ensure work is completed in compliance with approved quality and regulatory standards
• Ensure proper oversight of development, manufacturing and testing operations at contract sites
• Establish and oversee the device development related aspects of the departmental budget
• Review and ensure the accuracy, completeness, and compliance of the device sections for combination Drug Product sections of the eCDT for INDs and NDAs/BLAs

Skills and Qualifications

• Master's degree in Biomedical or Mechanical Engineering or similar discipline and a minimum of 18 years of experience working with pharmaceuticals / biopharmaceuticals
• A minimum of 15 years of experience in a GMP pharmaceutical/biopharmaceutical environment with drug delivery medical device experience
• Subject Matter Expertise in the development and commercialization of delivery devices and combination products
• Comprehensive expertise with drug and device regulations in support of FDA and EU submissions
• Expertise in engineering documentation and guidelines (i.e. ISO & ASTM)
• Expertise in device Quality Management Systems (i.e.21CFR820 & ISO 13485)
• Expertise in Drug Product cGMPs (i.e. 21CFR210/211)
• Expertise in FDA Design Controls and cGMP principles and work environment
• Experience in CAD Software or SOLIDWORKS
• Experience with QbD principles in general and specifically as they relate to device development
• Delivery Device Project Management experience from Proof-of-Concept Stage to Commercialization
• Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications
• Competencies: Results-oriented, Attention to Detail, Interpersonal skills, Verbal and Written Communication skills, Project Management, Analytical skills

Working Conditions

• Position may require travel and periodic evening and weekend work, as necessary to fulfill obligations and meet corporate goals.
• Occasional overnight travel may be required.
• This position is based in Xeris' Chicago office and requires five days per week on site.

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.

#LI-ONSITE

The anticipated base salary range for this position is $273,600 - $364,800.

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.

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 recruiting@xerispharma.com 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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