Director, Analytical Chemistry
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, academic and industry partners, and vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs. 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
