Principal Scientist, Analytical Development & Formulation

Lever, Inc.; San Diego (CA); On-site; USD 170,000 - 185,000; Full time

Benefits offered by this job

Annual bonus program

Incentive stock option plan

401k plan with flat employer contrib.

Comprehensive medical insurance (emloy

Dental and vision insurance

HSA/FSA and supplemental plans

Unlimited PTO

Relocation assistance

Job summary

Janux Therapeutics, Inc. is seeking a Principal Scientist to lead analytical and formulation development for biologics in immuno-oncology and autoimmune disease. You will oversee method development, formulation studies, stability programs, and external CRO/CMO collaborations to advance programs from preclinical to clinical and plans for commercialization.

The role requires Ph.D./M.S./B.S. in relevant fields with 4/8/10+ years’ industry experience, strong regulatory knowledge, and leadership

Qualifications

• Ph.D., M.S., or B.S. in analytical chemistry, cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4/8/10 years 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.

Responsibilities

• Develop 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 regulatory compliance.
• Provide oversight of reference standard programs.
• Collaborate with cross-functional teams to advance projects from development to commercialization.
• Provide technical leadership and mentorship to junior scientists.
• Author and review technical reports and regulatory submissions.
• Conduct pre-formulation characterization and formulation studies for 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 in lab experiments and equipment.
• Other duties as assigned by management.

Skills

Analytical method development

Validation

Formulation development

Regulatory knowledge

QbD principles

External CRO/CMO management

Problem solving

Communication skills

Leadership/mentorship

Education

Ph.D. in analytical chemistry or related

M.S. in analytical chemistry or related

B.S. in analytical chemistry or related

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.

ESSENTIAL FUNCTIONS AND 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.

REQUIRED EDUCATION, EXPERIENCE, 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 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.

$170,000 - $185,000 a year

In addition to a competitive base salary ranging from $170,000 to $185,000, 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. Relocation assistance may also be available.

Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

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.