Principal Scientist, Analytical Development & Formulation

Januxrx; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Janux Therapeutics, Inc. seeks a Principal Scientist to lead analytical and formulation development for biologics in immuno-oncology and autoimmune disease. You will supervise CDMOs, develop analytical methods, and oversee stability and regulatory activities.

The role emphasizes cross-functional collaboration, mentorship of junior scientists, and hands-on leadership in a fast-paced development environment.

Qualifications

• Ph.D., M.S., or B.S. in relevant field with industry experience.
• Extensive experience in analytical method development, validation, and troubleshooting.
• Proven formulation development experience for protein therapeutics.
• Strong knowledge of FDA/ICH/pharmacopoeia and cGMP guidelines.
• Experience with advanced analytical techniques in biologics.
• Familiarity with QbD and risk-based approaches.
• Experience managing external CROs/CMOs.
• Excellent organizational, written and verbal communication skills.

Responsibilities

• Develop and qualify/validate analytical methods for drug substances/products at CDMOs.
• Design formulation development studies to support preclinical/clinical programs.
• Oversee stability studies and regulatory compliance.
• Provide oversight of reference standard programs.
• Collaborate with Research, Quality, Regulatory Affairs to advance projects.
• Provide technical leadership and mentorship to junior staff.
• Author/review technical reports and regulatory submissions.
• Conduct pre-formulation characterization and formulation studies.
• Develop/implement protocols for analytical method qualification and formulation development.
• Ensure accurate documentation and reporting of activities and results.
• Support compatibility testing of clinical supplies.
• Troubleshoot and resolve lab issues.
• Perform other duties as assigned by management.

Skills

Analytical method development

Regulatory knowledge

Protein formulation

Leadership

CRO/CMO management

QbD principles

Team collaboration

Problem solving

Education

Ph.D.

M.S.

B.S.

Tools

HPLC

Mass spectrometry

Statistical analysis

Job description

We are seeking a highly skilled and motivated Principal Scientist to join our Analytical and Formulation Development team. The successful candidate will lead and oversee analytical and formulation development activities for our pipeline of therapeutic candidates in immuno-oncology and autoimmune disease. This role requires a deep understanding of analytical methodologies, formulation development of biologics, regulatory requirements, as well as experience managing analytical development and QC activities at CDMOs.

Responsibilities

• Responsible for the development and qualification/validation of analytical methods for drug substances and drug products at CDMOs.
• Design and execute formulation development studies to support preclinical and clinical programs.
• Oversee stability studies and ensure compliance with regulatory guidelines.
• Provide oversight of reference standard or reference material programs.
• Collaborate with cross-functional teams including Research, Quality, and Regulatory Affairs, to advance projects from early development through commercialization.
• Provide technical leadership and mentorship to junior scientists and research associates.
• Author and review technical reports and regulatory submissions.
• Conduct pre-formulation characterization and formulation studies to develop clinical formulations.
• Develop and implement protocols for analytical method qualification and formulation development.
• Ensure accurate documentation and reporting of laboratory activities and results.
• Support compatibility testing of clinical supplies.
• Troubleshoot and resolve technical issues related to laboratory experiments and equipment.
• Other duties as assigned or deemed necessary by management.

Requirements

• Ph.D., M.S., or B.S. in analytical chemistry, cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (Ph.D.), 8 years (M.S.) or 10 years (B.S.) of directly relevant industry experience, preferably with biologics.
• Extensive experience in analytical method development, validation, and troubleshooting.
• Proven track record in formulation development for protein therapeutics.
• Strong knowledge of regulatory requirements (FDA, Ph. Eur., 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.
• Must have experience in managing external CROs and CMOs.
• 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-time

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance

Schedule

• Monday to Friday

Work Authorization

• United States (Required)

Additional Compensation

• Annual targeted bonus %

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.