Senior Scientist, Analytical Development

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 development activities for our pipeline of therapeutic candidates. As a vital member of the group, this individual will have a deep understanding of analytical methodologies and should be able to maintain high standards of technical and quality excellence.

• Develop analytical methods to ensure projects progress as planned, and process and products meet quality and regulatory requirements.
• Work hands-on to develop and routinely apply state-of-art analytical methods (HPLC assays like SEC, RP, IEX, HIC; CE; icIEF; biophysical assays etc.) for purity and impurity testing and characterization.
• Conduct developability assessment of pre-clinical candidates and provide early feedback on CQAs. Perform pre-formulation and formulation development studies, comparability testing, forced degradation and stability studies to support preclinical and clinical programs.
• Develop and apply new techniques for characterization of novel classes of protein therapeutics for research, process development, and clinical development.
• Perform assay qualification and method transfers to CDMOs/CROs to support clinical manufacturing, release and stability studies as well as analytical comparability studies.
• Oversee method performance, release and stability studies for RS, DS, DP at CDMOs.
• 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.
• Support compatibility testing of clinical dosing supplies and interact with clinical operations team.
• Write and diligently review analytical test methods, development reports, qualification protocols and reports, regulatory submissions and scientific publications etc.
• 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.
• Ensure accurate documentation and reporting of laboratory activities and results.
• Other duties as assigned or deemed necessary by management.

• 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.
• Extensive hands-on experience and in-depth knowledge in instrumentation and modern analytical chemistry techniques for proteins (e.g. SEC, IEX, HIC, RP-HPLC, CE-SDS, icIEF and biophysical methods such as DSC/DSF, DLS, HIAC etc.).
• Significant experience with analysis of recombinant proteins, mAbs, ADCs and or bispecifics highly preferred.
• Proven record in developing and applying new techniques for complex proteins, attention to detail in experimental design and data quality, as well as excellent troubleshooting skills.
• Experience with ELISA and cell-based assays is desired but not required.
• Experience with assay development, qualification/validation, and tech transfer to CDMOs to support clinical manufacturing.
• Knowledge of regulatory requirements (FDA, EMA, ICH) and cGMP guidelines.
• 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 verbal, presentation and written communication skills. Excellent problem-solving skills and the ability to work independently and collaboratively.

Job Type: Full-time

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 assistance

Schedule:

·         Monday to Friday

Work authorization:

·         United States (Required)

Additional Compensation:

·         Annual targeted bonus X%

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.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.