Support process development and technical transfer of drug products in clinical development and/or post-commercialization phases. Ensure products are developed and manufactured per current regulatory requirements and industry standards (cGMP’s, QbD, ICH, etc.) by serving as a primary Point of Contact (POC) and Subject Matter Expert (SME) for external Contract Manufacturing Organizations (CMOs). Supports authorship for technical process documentation such as but not limited to Process Descriptions, QbD assessments, master batch records, technical risk assessments, etc.
The Engineer I will demonstrate a basic understanding of the manufacturing unit operations (e.g. drug product formulation, sterile filtration, filling, inspection, analytics, etc.), equipment, supply chain from drug product manufacturing through commercial packaging and how the different departments within the organization interact with each other. The Engineer I will assist with planning and execution of routine technical assignments and demonstrate a general understanding of relevant pharmaceutical regulations related to cGMP manufacturing.
Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:• Serves as the Subject Matter Expert (SME) for drug product manufacturing process development and technical transfer – internally and externally.• Serves as the primary POC for CMO relationships.• Provides on-site support at CMOs during critical manufacturing activities• Supports authorship for technical process documentation such as but not limited to Process Descriptions, QbD assessments, technical risk assessments, etc. – internally and/or externally.• Reviews and provides technical input for GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations – internally and/or externally.• Supports routine, day-to-day manufacturing activities to ensure product meets quality and business requirements.• Evaluates manufacturing technologies, equipment, and processes for continuous improvements throughout product development and product lifecycle management. • Works cross-functionally to support forecasting, scheduling, and budgeting of process development and/or technical transfer activities.• Works cross-functionally to manage logistical activities such as quotes, purchase orders, invoices, inventory management and shipment of product.• Accurately collects / performs data mining and appropriately records / trends observations.• Collaborate with other functions such as CMC, Formulation Development, Analytical Development, Device Development, Quality Assurance, Quality Control, Regulatory, Project Management, and Finance.
• Bachelor’s/Master’s degree required in Engineering or relevant Scientific discipline, or equivalent degree with a minimum of 3 years of experience working in pharmaceuticals. • Minimum of 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with knowledge of aseptic processing and sterile drug product manufacturing. • Must have strong technical writing, critical thinking, problem solving, analytical, communication (verbal and written), and computer (including all Microsoft Office) skills.• Must have experience leading or supporting process development, process validation and/or technical transfer.• Must be able to work cross-functionally across internal and external organizations. • Preferred skills include project management, budgeting, etc.• Competencies: honesty, self-driven, teamwork & collaboration, attention to detail, eagerness to learn, adaptability, professionalism, accountability
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel is required up to 25-50% at times to include CMOs and the Chicago office (if remote). Periodic overnight travel may also be required. For Chicagoland-based candidates: The incumbent is required to be on-site in Xeris’ Chicago office five days per week.
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 $70,000 - $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 commission 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.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
