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 Description:
We are seeking an experienced and highly motivated Head of CMC to build and lead our Chemistry, Manufacturing, and Controls (CMC) function. The successful candidate will be a strategic leader with a quality mindset and a proven track record of success in developing and executing CMC strategies with CROs and high profile partners for both small molecule and biologic drug candidates. This is a critical role that will build an internal and external team responsible for overseeing all aspects of CMC activities from preclinical through early clinical development and clinical proof of concept.
Responsibilities:
- Develop and implement effective and innovative CMC strategies for a diverse portfolio of drug candidates, including small molecules, biologics, and potentially novel modalities
- In partnership with CMOs (contract manufacturing organizations) and high-profile partners, oversee all aspects of CMC activities, including process development, formulation, scale-up, technology transfer, manufacturing, quality control, and stability studies
- Establish and maintain robust CMC processes and systems to ensure compliance with all applicable regulations and guidelines
- Build strong relationships with CMOs and other external partners
- Ensure timely and efficient delivery of high-quality drug substances and drug products for nonclinical studies and clinical trials
- Lead/oversee the preparation and submission of CMC sections for regulatory filings, including INDs, IMPDs, NDAs, and BLAs
- Interact with regulatory partners on CMC-related matters
- Collaborate effectively with cross-functional teams, including Project Development teams, Research, Development, Clinical, Regulatory, and Quality
- Communicate CMC strategies and progress to senior management and other stakeholders
- Represent Calico in external collaborations and partnerships
Position Requirements:
- Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline
- 15+ years of experience in CMC drug development, with at least 5 years in a leadership role
- Extensive experience with both small molecule and biologic and/or peptide drug development
- Demonstrated ability to apply scientific and engineering principles for crafting innovative and practical solutions to technical problems
- Demonstrated ability to create and execute strategies for successful product development via effective management of internal and external resources
- Deep understanding of FDA and GMP regulations, ICH guidelines, and global regulatory requirements
- Excellent leadership and management skills with the ability to build and motivate high-performing teams with a focus on scientific excellence, innovation and operational effectiveness, including safety, quality compliance and continuous improvement
- Strong strategic thinking and problem-solving abilities
- Exceptional communication and interpersonal skills, with the ability to effectively interact and influence internally with cross-functional stakeholders and senior leadership and externally with CMOs and regulatory authorities
- Must be willing to work onsite at least 4 days a week
The estimated base salary range for this role is $294,000 - $301,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.