Senior Manager, Device Development

Senior Manager, Device Development

The Senior Manager, Device Development is accountable for the technical development of Xeris' device and combination product programs to ensure commercialization strategy and objectives are met. This role identifies and leads development projects for device and combination product delivery systems, according to established standards for Design Controls and product development processes. This includes providing leadership to a cross-functional team, encompassing all aspects of device development : design input, design output, specification development, test method development, design verification / validation, process validation, design transfer, and risk management. The Senior Manager leads the coordination and collaboration with contract development and manufacturing organizations (CDMOs), by serving as the key liaison between internal departments and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF) and Device Master Record (DMR) and makes significant contributions to associated regulatory submissions.

Responsibilities :

• Manage Design and Development activities for new and existing drug / device combination products to ensure they meet or exceed requirements and can be manufactured with the highest quality.
• Manage device and combination product development projects effectively using available project management tools.
• Provide subject matter expertise in areas of device development, drug delivery, and commercialization.
• Manage the translation of Target Product Profiles (TPPs) into specifications.
• Manage design and development in accordance with regulatory regulations.
• Manage CDMO production for product development, clinical, and commercial launch manufacturing.
• Work in a cross-functional team environment to troubleshoot and resolve technical and manufacturing-related issues.
• Work in compliance with established cGMP quality standards.
• Manage development, manufacturing, and testing operations at contract sites.
• Adhere to departmental and project budgets.
• Contribute to authoring device sections for relevant sections of the eCDT for INDs and NDAs

Qualifications :

Competencies : Cross functional leadership, Business and strategic alliances and relationships, 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. This position is based in Xeris' Chicago office and requires a minimum of four days per week on-site. On-site requirements may change at management's discretion.

The level of the position will be determined based on the selected candidate's qualifications and experience.

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 $110,000 to $220,000. 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.

Job Locations US-IL-Chicago