Engineer II, Manufacturing Science

3 weeks ago

Chicago, United States Xeris Pharmaceuticals, Inc. Full time
Overview

The Engineer II, Manufacturing Science & Technology position is responsible for all aspects of process development, scaleup, technology transfer, and commercialization for Xeris's pipeline programs and will also provide technical support as needed for Xeris' commercial products. This includes responsibilities for internally developed drug substances (APIs), intermediates, and drug products (formulations) as well as development-stage and commercial-stage programs that may be in-licensed or acquired. Ensure products are developed and manufactured per current regulatory requirements and industry standards (cGMP's, QbD, ICH, etc.). Ensure raw materials and components are available and product is manufactured within established development, clinical or commercial timelines. Work cross-functionally with other teams to ensure commercial product is available for sale per commercial forecasts. The Engineer II will demonstrate a broad understanding of manufacturing unit operations, equipment, supply chain from drug product manufacturing through packaging and distribution and how the different departments within the PDTO organization interact with each other. The Engineer II will assist with planning and execution of routine technical assignments and demonstrate a firm understanding of relevant pharmaceutical regulations related to cGMPs.

Responsibilities

Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to:
  • Assists in planning development studies and clinical supplies manufacturing, which includes forecasting, budgeting, and scheduling.
  • Interface and collaborate with the product development group for knowledge and technology transfer of products to manufacturing sites.
  • Evaluate alternative technologies and equipment for manufacturing process improvement.
  • Supports colleagues in routine, day-to-day manufacturing activities to ensure product is manufactured on time within development, clinical or commercial timelines.
  • Provides on-site support at Contract sites (CMOs, etc.) during critical manufacturing activities.
  • Helps with logistics activities such as quotes, purchase orders, invoices, inventory management and shipment of product.
  • Frequently interacts with other functional peer group managers and CMOs to support development, clinical or commercial manufacturing activities.
  • Accurately collects / performs data mining and appropriately records / trends observations.
  • Writing technical protocols and reports for process engineering studies.
  • Aids 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 Product Development, Device Development, Quality Assurance, Quality Control, Regulatory and Finance.
Qualifications
  • Bachelor's/Master's degree required in Engineering or relevant Supply Chain, Scientific, or equivalent degree with minimum 5 years of experience working in a pharmaceutical industry.
  • Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with knowledge of aseptic processing and sterile drug product manufacturing.
  • Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management.
  • Skills preferred: Data Management, Project Management, Manufacturing/Supply Chain background, Technical Transfer/Process Validation, Problem Solving, Communication (written and verbal), Organizational, Analytical, and Presentation skills.
  • Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Adaptability, Professionalism, Accountability.
  • Working Conditions: Domestic and international travel (up to 25%) required. May require periodic evening and/or weekend activity to meet company deadlines and/or satisfy peak project workloads. 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.

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.

#LI-HYBRID

  • Manufacturing Operations Specialist

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Global Life Science HubWe are collaborating with a leading biopharmaceutical company to support their growth. With recent FDA approvals, they are gearing up for substantial expansion by 2025, tripling their production capacity.To meet this demand, we are recruiting 6 Manufacturing Associates at various experience levels (I, II, III) for DS and DP...

  • Manufacturing Operations Associate

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Global Life Science Hub: As a leader in life science headhunting, we place professionals across the United States and Europe for various Biotechnology, Pharmaceutical, and CDMO companies. Our clients range from small start-ups to large global organizations, giving us unparalleled access to job opportunities in the field.Job Requirements: To succeed in this...

  • Downstream Manufacturing Technician

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    About the CompanyGlobal Life Science Hub is partnering with an innovative biotech company based in Chicago, IL to recruit for a Bioprocess Technician role. The company has secured two FDA approvals and is expanding its manufacturing capacity from 50L to 2000L by the end of the year.Job Description:We are seeking Manufacturing Associates I, II & III to assist...

  • Manufacturing Specialist

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Job OverviewWe are seeking a skilled Manufacturing Associate II to support our client's growing operations in their Chicago, IL facility. The successful candidate will assist with the downstream purification of mammalian cell cultures, focusing on processes from 50L to 1000L in a cGMP environment.Key ResponsibilitiesPerform downstream purification processes,...

  • Downstream Manufacturing Supervisor

    6 days ago

    Chicago, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionThe Downstream Manufacturing Supervisor is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and...

  • Manufacturing Science Expert

    3 weeks ago

    Chicago, Illinois, United States Xeris Pharmaceuticals, Inc. Full time

    Company OverviewXeris Pharmaceuticals, Inc. is a pharmaceutical company dedicated to developing innovative treatments for patients worldwide. Our team of experts is passionate about improving lives through cutting-edge research and development.Job DescriptionWe are seeking an experienced Manufacturing Science Expert to join our team in Chicago. As a key...

  • Manufacturing Process Specialist

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Job OverviewWe are seeking a highly motivated and detail-oriented individual to join our team as a Junior Manufacturing Associate. As a key member of our downstream manufacturing team, you will play a crucial role in the production of recombinant proteins in a cGMP environment.The ideal candidate will have a strong foundation in chemical, biological, or...

  • Junior Engineer

    5 days ago

    Chicago, United States Junior Engineer Full time

    Seeking a motivated Junior Engineer to join a rapidly growing manufacturing company specializing in consumer and institutional goods. This contract-to-hire opportunity offers the chance to contribute to the development, implementation, and improvement of systems and processes in a dynamic and collaborative environment.Essential Duties and...

  • Downstream Manufacturing Operations Manager

    21 hours ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    About Global Life Science Hub:We are an innovative biotech company based in Chicago, IL, that has recently secured two FDA approvals and boasts a strong pipeline of advanced assets. As we transition from R&D to full-scale commercial operations, we are rapidly expanding our facilities, with ambitious plans to scale our manufacturing from 50L to 2000L by the...

  • Manufacturing Process Supervisor

    2 days ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Job DescriptionWe are recruiting a Manufacturing Process Supervisor to oversee the production of drug products at our cutting-edge facility in Chicago. This role is responsible for managing daily operations, ensuring regulatory compliance, and leading a team to meet production objectives.Key Responsibilities:Supervise and manage daily operations in drug...

  • Biotechnology Manufacturing Director

    3 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Job OverviewWe are seeking an experienced Drug Product Manufacturing Supervisor to lead our aseptic manufacturing operations at our Chicago facility. This role is critical in ensuring the production of high-quality products that meet all regulatory requirements, driving our ambitious growth plans.About UsGlobal Life Science Hub is proud to partner with a...

  • Leading Drug Product Supervisor for Global Life Science Hub

    1 month ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    About the RoleAre you a seasoned professional in drug product manufacturing looking for a new challenge? Do you have what it takes to lead a team and drive production excellence? We are seeking an experienced Drug Product Supervisor to join our team at the Global Life Science Hub. As a key member of our operations team, you will be responsible for overseeing...

  • Downstream Manufacturing Supervisor

    6 days ago

    Chicago, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionWe are recruiting on behalf of an innovative biotech company based in Chicago, IL, that has recently secured two FDA approvals and boasts a strong pipeline of advanced assets. As they transition from R&D to full-scale commercial operations, they are rapidly expanding their facilities, with ambitious plans to scale their...

  • Aseptic Manufacturing Operations Leader

    2 weeks ago

    Chicago, Illinois, United States Global Life Science Hub Full time

    Job Overview:As a seasoned professional, you will have the opportunity to lead a team in the production of high-quality products within a specialized biopharmaceutical company. With a strong focus on regulatory compliance and operational efficiency, you will be responsible for supervising personnel and ensuring that manufacturing processes meet industry...

  • Manufacturing Process Engineer

    3 weeks ago

    Chicago, Illinois, United States CPS Full time

    **Job Description:**CPS is seeking a talented Manufacturing Process Engineer - Commercialization to support our R&D team. As a key member of the team, you will work closely with Manufacturing, Quality, and Supply Chain functions to ensure products meet high standards and consumer expectations.You will be responsible for monitoring the technical...

  • Manufacturing Engineer

    3 weeks ago

    Chicago, United States DESTACO Full time

    Manufacturing EngineerDestaco, a Stabilus CompanyWheeling, ILCompany ProfileDESTACO, a Stabilus Company, is a global leader in the design and manufacture of high-performance automation, workholding, and remote handling solutions. The company serves customers in variety of end-markets, including the automotive, life sciences, consumer goods, packaging,...

  • Manufacturing Engineer

    1 month ago

    Chicago, United States DESTACO Full time

    Manufacturing EngineerDestaco, a Stabilus CompanyWheeling, IL Company ProfileDESTACO, a Stabilus Company, is a global leader in the design and manufacture of high-performance automation, workholding, and remote handling solutions. The company serves customers in variety of end-markets, including the automotive, life sciences, consumer goods, packaging,...

  • Executive Manufacturing Director

    1 month ago

    Chicago, Illinois, United States Cenveo Manufacturing Full time

    Job OverviewCenveo Manufacturing, a leading North American manufacturer of envelopes with over 100 years of experience and approximately 30 billion envelopes manufactured annually, seeks an experienced Executive Manufacturing Director to lead its Chicago, IL facility.A Bachelor's degree in Engineering or Business is preferred but not required, and we will...

  • Manufacturing Engineering Manager

    3 weeks ago

    Chicago, United States DESTACO Full time

    Manufacturing Engineering ManagerDestaco, a Stabilus CompanyWheeling, ILCompany ProfileDESTACO, a Stabilus Company, is a global leader in the design and manufacture of high-performance automation, workholding, and remote handling solutions. The company serves customers in variety of end-markets, including the automotive, life sciences, consumer goods,...

  • Manufacturing Engineer Lead

    3 weeks ago

    North Chicago, Illinois, United States BioSpace Full time

    About the JobWe are seeking an experienced Manufacturing Engineer Lead to join our team at BioSpace. As a Manufacturing Engineer Lead, you will play a key role in the development and implementation of new manufacturing processes and equipment.About UsBioSpace is a leading biotechnology company dedicated to developing innovative medicines and solutions that...