Director, CMC Biologics

Who We Are:

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.

Position Summary:

Calico is seeking an experienced, highly motivated Director of CMC Biologics to lead and oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) development for our biologic drug candidates. This strategic role will focus on guiding programs from Investigational New Drug (IND) submission through commercialization, with a strong emphasis on process optimization and subcutaneous formulation development. The ideal candidate possesses deep expertise in biologics CMC, a comprehensive understanding of the drug development lifecycle, and a proven track record of successfully advancing biologic products in a highly regulated environment.

Key Responsibilities:

• CMC Strategy & Leadership: Develop and execute comprehensive CMC strategies for biologic programs, from IND-enabling activities through clinical development, regulatory submission, and commercialization
• Formulation Development: Provide expert leadership and oversight for the development of stable, manufacturable, and patient-friendly biologic formulations, with a specific focus on subcutaneous delivery methods
• Process Development & Manufacturing: Guide and oversee drug substance and drug product process development, manufacturing, and scale-up activities at Contract Development and Manufacturing Organizations (CDMOs)
• Analytical Development: Oversee the development and qualification of analytical methods for characterization, release, and stability testing of biologic drug substances and drug products
• Regulatory Submissions: Lead the preparation and authoring of CMC sections for regulatory filings (e.g., INDs, BLAs, MAAs), ensuring compliance with global regulatory requirements
• Vendor & CDMO Management: Identify, qualify, and manage CDMOs and other third-party vendors for all CMC-related activities, ensuring high-quality execution and adherence to timelines and budget
• Cross-functional Collaboration: Serve as the primary CMC lead on cross-functional project teams, collaborating closely with Research, Clinical, Regulatory Affairs, Quality Assurance, and Commercial teams
• Risk Management: Proactively identify CMC-related risks and develop robust mitigation strategies to ensure program success and uninterrupted supply
• Quality & Compliance: Ensure all CMC activities comply with global Good Manufacturing Practice (GMP) and relevant regulatory guidelines
• Technology Transfer: Oversee successful technology transfer activities between internal teams and CDMOs, and between different manufacturing sites
• Budget Management: Contribute to and manage CMC project budgets, identifying opportunities for efficiency

Position Requirements:

• Ph.D. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Minimum of 10 years of progressive experience in CMC development for biologic products within the biopharmaceutical industry
• Minimum of 5 years in a leadership or senior scientific role
• Demonstrated expertise in advancing biologic programs from IND submission through BLA/MAA approval and commercial launch
• Extensive hands-on experience and leadership in subcutaneous formulation development for biologics
• Proven experience managing CDMOs for drug substance and drug product manufacturing
• In-depth knowledge of biologics drug development, including upstream and downstream processing, purification, and aseptic fill/finish
• Strong expertise in protein chemistry, biophysical characterization, and stability assessment
• Comprehensive understanding of global GMP regulations (FDA, EMA, ICH) for biologics
• Proficiency in analytical method development and validation for biologics
• Familiarity with regulatory requirements for biologics CMC sections in global submissions
• Exceptional leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with diverse stakeholders
• Proven strategic thinking, problem-solving, and decision-making abilities in a complex and dynamic environment
• Strong project management skills, capable of managing multiple priorities and delivering results
• Detail-oriented with a strong commitment to quality and scientific rigor
• Adaptable and able to work effectively in a fast-paced, evolving organization
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $245,000 - $260,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.