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Calico Life Sciences · 2 weeks ago

Director, Formulation Development

South San Francisco, CA

Full-time

Onsite

Director/Executive

$240K/yr - $260K/yr

15+ years exp

Calico Life Sciences is an Alphabet-founded research and development company focused on understanding human aging and devising interventions for healthier lives. They are seeking a highly skilled Director of Formulation Development to lead formulation and drug product development for small molecule programs, ensuring successful progression from clinical development to commercial readiness.

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

Qualification

Formulation developmentQuality by Design (QbD)Process developmentRegulatory submissionsPh.D. in ChemistryProject managementLeadership skillsProblem-solvingTechnical writingCollaboration

Required

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

Benefits

Two annual cash bonuses

Company

Calico Life Sciences

Glassdoor4.1

Calico is an Alphabet-founded research and development company whose mission is to harness advanced technologies.

Founded in 2013

South San Francisco, California, USA

201-500 employees

http://www.calicolabs.com/

H1B Sponsorship

Calico Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2020 (14)