Associate Director, Analytical Development
A key member of the Analytical Development team, the Associate Director Analytical Development, will manage all aspects of analytical activities at CDMOs and CROs in support of bringing innovative protein therapeutics to patients. This role oversees method development, method qualification/validation, and stability programs and contributes to regulatory filings. The incumbent will collaborate with functional areas within CMC, therapeutic discovery, process development, quality, clinical, and regulatory teams.
Essential Functions and Responsibilities
- Act as the primary analytical expert for designated projects, managing all aspects of analytical development for biologics at CDMOs and CROs to ensure product quality aligns with project requirements and developmental stages.
- Collaborate independently and collaboratively with cross-functional teams and CDMOs/CROs to lead method development, transfer, qualification, and troubleshooting activities for the characterization and release testing of multiple pipeline products.
- Work independently and contribute to the Analytical CMC Strategy.
- Establish phase-appropriate quality control strategies, set specifications, provide oversight of stability studies at CDMOs, and perform retest date extensions and expiry extensions 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.
- Document, analyze experiments, and present results to multidisciplinary teams.
- 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 pre-IND and 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, chemistry, 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, ADCs or multidomain protein biologics is required.
- 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.
- Experienced in leading method suitability and qualification activities.
- 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.
- 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 cell-based potency assays is desired but not required.
- 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 is desired but not required.
- Experience with establishing phase-appropriate specifications for drug substances and drug products.
- 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 on 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, 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, 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
- Relocation assistance
Schedule
Work authorization
Additional Compensation
- Annual targeted bonus 20%
Work Location
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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