• Job Description

  Req#: 1938

  Overview

  This position is responsible for the development of analytical and characterization methods for a range of pharmaceutical dosage forms in support of formulation, process, and specification development. The Scientist I, Analytical Development will work with product development scientists (formulation and analytical) seeking to develop various therapeutic drug product formulations incorporating the company’s XeriSol and XeriJect technologies. This role will also support Quality Control and CMC with respect to establishing product specifications, stability programs, material qualification, method validation, method transfer and process validation.

  Responsibilities

  • Develop specific and selective chromatographic methods (HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Methods, where applicable, should be compatible with mass selective/mass spectroscopic detection.
  • Collaborate with formulation and other analytical scientists in the product development function to design adequate stability for new products for late stage clinical support.
  • Proficiency in reviewing microbiological test data, including bioburden, endotoxin, and sterility results.
  • Review and evaluate microbiology data generated by external contract testing laboratories (CTLs) to ensure compliance with specifications and regulatory standards.
  • Direct the design requirements/capabilities of new technologies required to support new product testing.
  • Keep current with relevant literature and industry standards as applicable to research areas.
  • Oversee the implementation of compendial monographs and procedures (USP, EP, etc.).
  • Perform the duties as required for Reference Standard programs, instrument maintenance/ calibration and stability programs (internal and external).
  • Configure and operate laboratory instruments, including HPLC, LCMS, Particle size analyzer, Karl Fischer Titrator, etc.
  • Read and record instrument data, tabulate data, and keep detailed laboratory records.
  • Draft Standard Operating Procedures (SOP’s) for advanced laboratory equipment (HPLC/UHPLC-MS) operation and maintenance.
  • Manage external contract laboratories for methods development/method transfer/QC testing.
  • Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects).
  • Write development reports for internal reference, relevant sections of IND, NDA and other regulatory documentation.
  • Adhere to department budgets

  Qualifications

  • A graduate degree in analytical chemistry (M.S. or Ph.D.) with a minimum of 1-3 years of relevant industrial pharmaceutical experience is preferred. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. with 3-5 years of method development experience in an industrial pharmaceutical laboratory will be considered.
  • Experience with GMP/GLP environments and understanding of FDA and ICH guidelines.
  • Proficiency in reviewing microbiological test data, including bioburden, endotoxin, and sterility results
  • Working knowledge of laboratory information management systems (LIMS) and document management systems.
  • Demonstrate understanding of modern chromatographic and theory, especially the chromatographic methods and theory for proteins and Biologics.
  • Prior experience working with external contract testing labs.
  • Understanding of method validation and transfer principles in a GMP setting.
  • Hands-on experience and expertise with Mass Spectroscopic detectors coupled with HPLC or UHPLC.
  • Ability to work independently as well as in a team.
  • Prior knowledge of successful regulatory submissions (IND/NDA/BLA) and commercial method support a strong positive. Demonstrated working knowledge of relevant ICH guidances also a plus.
  • Ability to draft routine reports and maintain accurate and detailed records of work performed.
  • Working knowledge of Microsoft Productivity software (Excel, Word, etc), Agilent ChemStation, and common statistical software like JMP and Minitab.
  • Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications
  • Working Conditions: Must be able to stand for extended periods of time. Must be able to lift 25 lbs. or more.Adequate vision (corrected or uncorrected) to read fine instruments such as calipers, instrument displays, etc., and perform visual inspection for defects. Position works with potentially hazardous chemicals and active pharmaceutical ingredients. May require periodic evening and weekend work, as necessary to meet company deadlines. Position may include periodic travel (domestic and international). This position is based in Xeris’ Chicago office and requires five days per week on-site. On-site requirements may change at management’s discretion.

  #LI-ONSITE

  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 to $120,000. 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.

• About the company

  Xeris offers a novel formulation technology to bring ready-to-use, liquid-stable injectables to patients to remove many associated treatment burdens.

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