Director, Analytical Chemistry

Calico•South San Francisco, CA

3d•$270,000 - $286,000•Onsite

About The Position

Calico is seeking an accomplished Director of Analytical Chemistry to lead our small-molecule analytical development function. This leader will play a pivotal role in advancing Calico’s development portfolio, supporting programs from pre-IND through commercialization. The ideal candidate will have deep expertise in designing phase-appropriate analytical methods, shaping analytical regulatory strategies, and driving comprehensive lifecycle management.

Requirements

PhD in Analytical Chemistry or a related field
Minimum 15 years of industry experience in analytical development of small molecule pharmaceuticals
Proven track record in regulatory submissions (NDA, MAA) and supporting global filings and inspections
Deep knowledge of ICH, USP, and other relevant regulatory guidelines
Expertise in a wide range of analytical techniques including HPLC, GC, dissolution, spectroscopy, particle characterization, and solid-state analysis
Experience with Quality by Design (QbD) principles and risk-based analytical development
Familiarity with analytical support for combination products or novel delivery systems
Experience managing external partners and driving CDMO performance
Strong leadership, organizational, and communication skills
Ability to thrive in a fast-paced, collaborative, and dynamic environment
Must be willing to work onsite at least 4 days a week

Nice To Haves

Experience with development of analytical methods for biologics is a major plus

Responsibilities

Expertise with developing analytical techniques and specifications for immediate release oral solid dosage, extended-release oral solid dosage, parenteral, and subcutaneous delivered products
Oversee characterization and control strategies for drug substances and drug products in alignment with ICH guidelines and global regulatory expectations
Serve as the analytical lead on CMC teams, actively contribute to regulatory filings, and act as an SME for health authority questions
Lead quality control function of GMP drug substance and drug product testing
Design stability studies, interpret data, and support shelf-life justifications and post-approval changes
Collaborate cross-functionally with formulation, chemical development, quality assurance, and regulatory teams to ensure alignment and program success
Manage external contract analytical resources to ensure high-quality and timely deliverables
Develop and implement phase-appropriate analytical strategies and quality control methods
Represent the company in regulatory meetings and inspections as an analytical subject matter expert