What are the responsibilities and job description for the Engineer I, Commercial Manufacturing position at Xeris Pharmaceuticals, Inc.?
Overview
Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP’s and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing.
Responsibilities
Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
- Assist in commercial production planning
- Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply
- Helps with logistics activities such as quotes, invoices, inventory management and shipment of products and intermediates
- Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities
- Accurately collects / performs data mining and appropriately records / trends observations
- Aid in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations
- Collaborate with other functions such as Device Development, Quality Assurance, Quality Control, Regulatory, and Finance
Qualifications
- Bachelor’s degree required, master’s degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals
- Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing
- Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management
- Skills preferred: Data Management, Manufacturing/Supply Chain background
- Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
- Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris’ Chicago office. A minimum of four days per week on site is required. On site requirement may change at management’s discretion.
The level of the position will be determined based on the selected candidate’s qualifications and experience.
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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 $80,000 to $110,000. 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 : $80,000 - $110,000