Job Description
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Overview The Scientist I, Analytical Development position is responsible for the development and implementation of analytical characterization methods for a range of pharmaceutical dosage forms to support formulation, process, and specification development. This position collaborates with product development scientists in developing therapeutic drug products utilizing the company's proprietary XeriSol® and XeriJect® platform technologies. This position also supports Quality Control and CMC functions in establishing product specifications, stability programs, material qualification, method validation, method transfer, and process validation.
Responsibilities - Develop and perform specific and selective chromatographic methods (i.e. HPLC, UHPLC, LCMS) for use in characterizing prototype pharmaceutical formulations. Where applicable, methods should be compatible with mass selective/mass spectroscopic detection.
- Collaborate with formulation and analytical scientists in the Product Development group to design appropriate stability programs for drug products.
- Proficiently configure, operate, and maintain analytical instruments including liquid chromatography systems (HPLC), Karl Fischer titrators, and particle size analyzer.
- Keep current with relevant literature and industry standards as applicable to research areas.
- Implement analytical procedures according to compendial monographs and standards (USP, EP).
- Perform the duties as required for reference standard programs, instrument maintenance and calibration, and drug product stability programs
- Collect, analyze, and interpret analytical instrument data while maintaining detailed laboratory records.
- Draft Standard Operating Procedures (SOPs) for laboratory equipment operation and maintenance.
- Manage external contract laboratories for method development, transfer, and QC testing.
- Assume a lead SME role in analytical chemistry related team roles and responsibilities (internal and external projects).
- Prepare development reports and contribute to regulatory submissions, including IND and NDA documentation.
- Adhere to departmental budgets and spending guidelines.
Qualifications - A Bachelor of Science degree with 3+ years of method development experience in an industrial pharmaceutical laboratory OR
- MS / PhD in analytical chemistry with 1+ years of relevant industrial pharmaceutical experience.
- Alternatively, a Ph.D. with relevant academic research experience may substitute for some industrial experience.
- An appropriate understanding of method development, method validation, and method transfer principles.
- Hands-on experience and expertise with HPLC or UHPLC is a must.
- Demonstrated understanding of modern chromatographic theory, particularly chromatographic methods focused on Peptides, Proteins and Biologics.
- Familiarity with GMP/GLP environments and understanding of FDA and ICH guidelines is a plus.
- Ability to work effectively both independently and collaboratively within a team environment.
- Prior experience with successful regulatory submissions (IND/NDA/BLA) and commercial method support is a plus.
- Developing study protocols and reports with meticulous attention to record accuracy and completeness.
- Working knowledge of Microsoft Productivity software (Excel, Word, PowerPoint, etc.) and Agilent OpenLab.
- Statistical analysis software such as GraphPad Prism, MiniTab, and JMP is a plus.
- Competencies: Teamwork & CollaborationAttention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Professionalism, Strong Written and Verbal Communication skills.
- 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 needed to meet program 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.
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 $80,000 - $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 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. Job Locations US-IL-Chicago Title Scientist I, Analytical Development ID 2025-2314 Category Product Development Type Full-Time If you have questions about this posting, please contact [email protected]
Job Tags
Full time, Contract work, Work at office, Weekend work, Afternoon shift,