 Vice President, Head of CMC

Firefly Bio • Full-time • San Francisco Bay Area, US • $250k - $350k / year • 6d ago

About Firefly Bio:

Firefly specializes in Degrader Antibody Conjugates (DACs) which combine the unique strengths of ADCs with selective protein degraders. Our state-of-the-art platform results in highly specific delivery of degraders to target tissue. Our mission is to realize the full potential of ADCs by unlocking new classes of payloads. Our company culture is built on the values of Focus, Integrity, Respect and Energy.

Position Summary:

Firefly Bio is seeking an experienced and strategic leader to join our team as Vice President, Head of Chemistry, Manufacturing, and Controls (CMC). Reporting directly to the CEO, this critical role will be responsible for all aspects of CMC development and manufacturing strategy for our portfolio of novel Degrader Antibody Conjugates (DACs). The successful candidate will lead the establishment and oversight of a primarily outsourced manufacturing model. This is a unique opportunity to shape the CMC function from pre-IND process development through clinical development and ultimately towards commercialization. A strong background in ADC development and manufacturing is essential.

Key Responsibilities:

Develop and execute comprehensive CMC strategies for Firefly Bio’s DAC programs, ensuring alignment with overall program and regulatory requirements, corporate goal scope and timing while considering risk mitigation opportunities.
Oversee all drug substance (including antibody, linker, payload, and conjugate) and drug product (including formulation, lyophilization, fill/finish) process development, scale-up, and manufacturing activities.
Partner with Firefly Bio’s Scientific and Technical Leadership on antibody, payload, linker, and conjugate planning and execution.
Develop strategies for and oversee analytical method development and analytical characterization strategies for antibody, linker-payload, and DACs, including implementation of well-designed stability programs.
Provide technical leadership for antibodycell line development, master cell bank selection, antibody production, purification and process development and manufacturing development.
Identify, select, and manage a global network of Contract Development and Manufacturing Organizations (CDMOs) for process and analytical development, manufacturing, testing and disposition of clinical supply of DACs.
Define strategies in partnership with Regulatory to ensure successful regulatory filings and interactions;spearhead and pursue INTERACT and/or Pre-IND meetings with regulatory agencies, as needed.
Author and provide critical review of CMC sections for regulatory submissions and annual reports (e.g., INDs, IMPDs, briefing documents, and future BLAs/MAAs) and interact with regulatory agencies as needed.
Ensure all CMC activities are conducted in compliance with cGMP, ICH guidelines, and relevant global regulatory standards.
Develop and manage CMC budgets, timelines, and risk mitigation plans.
Collaborate effectively with internal cross-functional teams including Research, Nonclinical Development, Regulatory Affairs, and Clinical Operations.
Foster a culture of scientific excellence, innovation, and operational efficiency within the CMC function, embodying Firefly Bio’s values of focus, integrity, respect, and energy.
Stay current with advancements in biologics, small molecule and ADC/DAC manufacturing technologies, analytical techniques, and regulatory expectations.

Qualifications & Experience:

Advanced degree (Ph.D. required) in Chemical Engineering, Chemistry, Biophysics, or a related scientific discipline.
Minimum of 12-15+ years of progressive experience in the biopharmaceutical industry, with a significant portion focused on CMC development and manufacturing of biologics.
Proven track record in early-stage CMC development of ADCs, including experience with antibody production and conjugation processes, analytical characterization, and managing unique ADC manufacturing challenges including OEB classifications and handling of highly active compounds.
Demonstrated experience in successfully managing outsourced CMC activities, including selection and oversight of CDMOs for biologics and/or ADCs.
Strong understanding of cGMP, ICH guidelines, and global regulatory requirements for IND and BLA/MAA submissions.
Hands-on experience authoring and reviewing CMC sections of regulatory submissions is required.
Proven leadership experience, with the ability to build, mentor, and manage a high-performing team (even if initially externally focused).
Experience in early-stage (preclinical to Phase 2) CMC development is required; late-stage development and commercialization experience is a plus.
Excellent organizational, problem-solving, and decision-making skills.
Strong interpersonal, communication (written and verbal), and presentation skills.
Ability to thrive in a fast-paced, entrepreneurial, and collaborative environment.

Benefits:

Every team member is essential in shaping Firefly Bio’s culture and science and for our success. We offer competitive compensation packages including stock options and the opportunity to be part of ground-breaking research. Firefly Bio is an equal opportunity employer and will consider all applicants for employment. Firefly Bio does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.