Principal Scientist, Analytical Development & Formulation

Lever, Inc.

San Diego (CA)

On-site

USD 170,000 - 185,000

Full time

9 days ago

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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.