Director, Formulation Development

Calico • South San Francisco, CA

127d • $240,000 - $260,000

About The Position

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs. Calico is seeking a highly skilled Director of Formulation Development to lead formulation and drug product development efforts for our mid- to late-stage small molecule programs, including oral solid dosage forms and parenteral formulations. This role will be instrumental in progressing our pipeline from clinical development through commercial readiness, applying state-of-the-art formulation science and Quality by Design (QbD) principles.

Requirements

• Ph.D. in Chemistry, Chemical Engineering, or Pharmaceutical Sciences
• 15+ years of relevant industry experience, with a strong track record in formulation development of various oral solid dosage products
• Deep understanding of QbD, process development, and scale-up for late-stage programs
• Experience working with external CDMOs and managing outsourced drug product development and manufacturing
• Demonstrated success in contributing to regulatory submissions (e.g., IND, NDA, MAA) and responding to agency queries
• Strong technical writing, problem-solving, project management, and leadership skills
• Ability to thrive in a fast-paced, collaborative, and mission-driven biotech environment
• Must be willing to work onsite at least 4 days a week

Responsibilities

• Lead process validation and supporting commercial launch activities
• Lead the development, optimization, and scale-up of oral solid dosage forms, including capsule, tablets, and mini-tablet presentations for small molecule drug candidates in mid- to late-stage development
• Lead the development, optimization, and scale-up of parental therapies, including prefilled syringe and lyophilized formats for small molecule drug candidates in early development
• Design and execute robust, phase-appropriate formulation strategies that support clinical development, process validation, and commercial launch
• Apply QbD and risk-based development approaches to define critical quality attributes (CQAs) and critical process parameters (CPPs)
• Oversee technology transfer to external CDMOs and ensure successful execution of clinical and commercial cGMP manufacturing campaigns
• Support preparation and review of CMC sections of regulatory filings for INDs, IMPDs, NDAs, MAAs
• Participate in regulatory agency interactions and inspections as a subject matter expert
• Manage and mentor a team of formulation scientists and external partners to deliver on-time, high-quality results
• Lead the selection and characterization of excipients, container closure systems, and manufacturing processes
• Collaborate cross-functionally with Analytical, Process Chemistry, Regulatory, Quality, and Supply Chain to ensure program alignment
• Evaluate new technologies and formulation platforms to support lifecycle management and product differentiation

Benefits

• Estimated base salary range of $240,000 - $260,000
• Eligible for two annual cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees