Senior Scientist, Analytical and Formulation Development

Company: Exokeryx
Location: San Diego
Posted on: March 1, 2025

Job Description:

We are seeking a highly skilled and motivated Senior Scientist to join our Analytical and Formulation Development team. The successful candidate will independently perform analytical and formulation development activities for our pipeline of therapeutic candidates. This role requires a deep understanding of analytical methodologies, formulation development strategies, regulatory requirements, as well as experience with method transfers, troubleshooting and oversight of analytical development and QC activities at CRO's and CDMOs.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Develop analytical methods and formulations to ensure projects progress as planned and meet quality and regulatory requirements.
• Oversee method transfers to CDMOs, and additional method and stage-appropriate formulation development or optimization at CDMOs.
• Conduct developability assessments of pre-clinical candidates and provide early feedback on CQAs.
• Perform pre-formulation characterization and formulation development studies to support preclinical and clinical programs.
• Support compatibility testing of clinical dosing supplies and interact with clinical operations team.
• Develop and implement protocols for analytical method qualification and formulation development.
• Perform laboratory-based experiments to optimize formulations and analytical methods.
• Develop and apply new techniques for characterization of novel classes of protein therapeutics for research, process development, and clinical development.
• Perform and oversee testing/characterization of critical reagents and manage reference standard or reference material programs.
• Perform stability tracking and trending of DS, DP and critical reagents generated in-house and at CDMOs.
• Collaborate with cross-functional teams, including Research, Quality, and Regulatory Affairs, to advance projects from early development through commercialization.
• Stay current with industry trends and advancements in analytical and formulation technologies.
• Troubleshoot and resolve technical issues related to laboratory experiments and equipment.
• Author, review and approve technical protocols, reports, regulatory submissions, and scientific publications.
• Ensure accurate documentation and reporting of laboratory activities and results.
• Other duties as assigned or deemed necessary by management.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • Ph.D, M.S., or B.S. in analytical chemistry, cell and/or molecular biology, engineering, or relevant discipline with a minimum of 2 years (PhD), 6 years (M.S.), or 8 years (B.S.) of direct relevant industry experience, preferably with biologics.
  • Must have experience in overseeing activities at external CROs and CDMOs.
  • Experience with analysis of mABs and/or bispecifics is required.
  • Extensive experience in analytical method development, validation, and troubleshooting, e.g., SEC, CE-SDS, iCIEF, CEX, RP-HPLC and biophysical methods.
  • Experience with ELISA and cell-based assays is desired but not required.
  • Proven track record in formulation development for biologics indications.
  • Strong knowledge of regulatory requirements (FDA, EMA, ICH) and cGMP guidelines.
  • Experience with advanced analytical techniques utilized in drug development for biologics.
  • Familiarity with Quality by Design (QbD) principles and risk-based approaches.
  • Demonstrates exceptional organizational skills, ensuring all tasks and projects are systematically managed.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
  • Excellent problem-solving skills and the ability to work independently and collaboratively.
  • Strong written and verbal communication skills.Job Type: Full-timeSalary: $135,000 - $150,000 a yearIn addition to a competitive base salary ranging from $135,000 to $150,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Benefits:
    • 401K
    • Medical insurance
    • Dental insurance
    • Vision insurance
    • Supplemental disability insurance plans
    • Flexible schedule
    • Life insurance
    • Flexible vacation
    • Sick time
    • Incentive stock option plan
    • Relocation assistanceSchedule: Monday to FridayWork authorization: United States (Required)Work Location: On site (San Diego, CA)EQUAL OPPORTUNITY EMPLOYER: Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
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Keywords: Exokeryx, San Diego , Senior Scientist, Analytical and Formulation Development, Other , San Diego, California