A key member of the Analytical Development team, the Associate Director, Analytical Development will help develop and drive state-of-the-art assay development to support Janux’ portfolio of preclinical and clinical-stage candidates for its proprietary programs within the pipeline. The incumbent will work collaboratively with functional areas within therapeutic discovery, process development, quality, clinical, and regulatory teams and manage analytical activities at CROs/CDMOs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Work both independently and collaboratively with cross-functional teams to lead and contribute to the Analytical CMC Strategy
• Act as the primary analytical expert for designated projects, managing all aspects of analytical development at Contract Manufacturing Organizations (CMOs) to ensure product quality aligns with project requirements and developmental stages
• Collaborate with cross-functional teams and CMOs to lead method development, transfer, qualification, and troubleshooting activities for the characterization and release testing of multiple pipeline products
• Establish phase-appropriate quality control strategies, set specifications, conduct stability studies, and determine retest dates or shelf lives for drug substances and drug products
• Lead and execute development of CE-SDS, iCIEF, RP-HPLC/UPLC, SEC, ELISAs and biophysical methods, including analysis and interpretation of data thereof
• Document, analyze experiments, and present results to a multidisciplinary team
• Conduct comprehensive reviews of data collected from development and clinical supply samples
• Author technical reports, protocols, and relevant sections of regulatory filings for US FDA and Ex-US including IND
• Manage, train, and mentor junior team members
• Travel: Up to 25% of the time – occasional international travel to partner and/or contracted facilities related to engineering, GMP and PPQ runs
• Other duties as deemed necessary

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• B.S., M.S. or Ph.D. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (PhD), 8 years (M.S.) or 10 years (B.S.) of directly relevant industry experience, preferably with biologics.
• Experience with development of mAbs or multidomain protein biologics is highly preferred
• Knowledge and experience in developing assays for biologic drug development programs with understanding of regulatory constraints relating to cGMP, ICH guidelines, USP, and EP compendial methods.
• Experience working in cross-functional environments, and with internal/external partners to perform method transfer and qualification for cGMP production.
• Experience leading method development projects involving CE-SDS, iCIEF, RP-HPLC/UPLC, SEC and ELISA.
• Experience with cellular based potency assays desired but not required.
• Experience leading method suitability and qualification activities
• Must be able to manage drug substance and drug product stability programs for biologics including stability data trending, stability protocols, and stability reports.
• Knowledgeable of advancements in analytical technologies and industry best practices, applying relevant innovations to enhance analytical capabilities and efficiency
• Working knowledge of performing retest period and expiry extrapolation using statistics.
• Experience with establishing phase-appropriate specifications for drug substance and drug product.
• Manage multiple reference standard programs including establishment of primary and working reference standards as well as setting requalification criteria.
• Must have a strong understanding of Quality Control systems including the following:
  • Release data review
  • Stability data review
  • OOT procedures
  • OOS procedures
  • Good Documentation Practices
  • Understanding of LIMS and cGMP lab data traceability
  • Change Management systems

• Must have strong data analysis skills and a working knowledge of the statistical analysis of data.
• Outstanding leadership, critical thinking and organizational skills, and attention to detail
• Relentless problem-solving abilities and a proactive approach to addressing challenges in analytical development
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Must be able to demonstrate a strong willingness to learn and adapt, with a commitment to continuous personal and professional development
• Occasional travel required (0 to 25%)

Compensation:

In addition to a competitive base salary ranging from $178,000 to $197,000, we offer stock options, 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, internal equity and work location.

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

Schedule:

• Monday to Friday

Work authorization:

• United States (Required)

Additional Compensation:

• Annual targeted bonus %

Work Location:

• Onsite - 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.