Who We Are: 

Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline comprises multiple clinical stage development programs including TERN-701, an allosteric BCR-ABL inhibitor for CML, and TERN-601, a small-molecule GLP-1 receptor agonist for obesity.  

Who We Are Looking For:

The Senior Director, Drug Substance will lead the drug substance function of the CMC department at Terns. This individual will manage all small molecule drug substance development activities for both early and late stage development programs.  This individual will be responsible for chemical route scouting, process optimization technology transfer and drug substance manufacturing activities at external CMO’s to support non-clinical and clinical programs. This individual will ensure that (1) appropriate scientific and technical standards are established; (2) robust data are available to support regulatory filings; and (3) in partnership with quality assurance, that appropriate quality controls are implemented and executed (4) collaborate with both internal and external teams to achieve project objectives.  This position is based out of our Foster City Headquarters and will report directly into the SVP of CMC.

What You’ll Do:

• Develop and execute strategy that is phase-appropriate and well positioned for accelerated development of small molecule programs
• Develop a comprehensive understanding of the control strategy for starting materials, intermediates, and drug substance, and convert this understanding into specific unit operation requirements to achieve a robust manufacturing process
• Lead process development studies according to the principal of Quality by Design, specification justification studies to establish limits, process characterization studies to identify proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge of failure, characterization of drug substances to identify critical quality attributes (CQAs)
• Provide direction to the CRO/CMO in terms of drug substance development strategies and technical expertise
• Drive continuous improvements in the drug substance development process through technological innovations and problem solving
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and other CMC functional groups, to drive the successful development of drug substances
• Actively contribute to writing key pharmaceutical development sections of regulatory documents IND/IMPD/NDA

What You’ll Bring to Our Team:

• Ph.D. in Organic Chemistry, Chemical Engineering, or a related field with a minimum of 10 years’ of small molecule biopharmaceutical industry experience
• Well-versed and demonstrated success in the application of QbD principles
• Proven track record of successfully leading small molecule programs from preclinical, clinical and validation stages, resulting in regulatory submissions and approval
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) pertaining to drug substance development and commercialization
• Experience managing contract manufacturing organizations (CMOs) and external partners/vendors
• Excellent leadership and project management skills, with the ability to effectively prioritize and manage multiple projects simultaneously
• In-depth understanding of cGMP principles and experience working in a regulated manufacturing environment
• Proactive mindset with a focus on problem-solving and continuous improvement
• Strong analytical and critical thinking abilities, with a keen attention to detail
• Ability to travel up to 30%

The expected base pay for this full-time exempt position is $245 – 275K + bonus + equity + benefits. At Terns, our salary ranges are determined by role, level, and location. The ranges are subject to change and individual pay within that range can vary for several reasons including location, skills/capabilities, experience, and available budget.

Terns Pharmaceuticals is committed to being an Equal Opportunity Employer and our policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.