Vice President, Antibody Drug Conjugate (ADC) CMC

Who We AreAvenzo Therapeutics, Inc. ("Avenzo") is an early-stage biotechnology company focused on developing the next generation of oncology therapies for patients. The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, respectively). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The company is headquartered in San Diego, California.Position SummaryReporting to the Senior Vice President, Global Product Strategy, the Vice President, Antibody Drug Conjugate (ADC) Chemistry, Manufacturing, and Controls (CMC) will drive CMC outsourcing strategy and supporting technical oversight of Contract Development and Manufacturing Organization (CDMO) partners to develop, scale up and manufacture clinical trial products for the Antibody and Antibody drug conjugate. This individual will lead the strategy and operations of our ADC programs throughout the product development lifecycle. Manage the clinical supply chain for Avenzo by collaborating closely with Avenzo's drug development Partners, manufacturing organizations, associated laboratories, and logistical support companies.This individual will be a key member of global product teams, and will work closely with various functions such as clinical operations, project management, quality, regulatory, and finance and oversee all aspects of CMC, including process development, analytical development, manufacturing, and regulatory submissions. The incumbent will have a proven track record of contribution to the ADC clinical pipeline from early phase development through registration and commercialization. They will have complete accountability for the multiple pipeline ADC projects, development of relevant science and technology, people management and organizational development, and implementation of functional strategies. They will ensure that the function's deliverables are completed within established timelines, budgets, resource allocation and in accordance with regulatory, quality, and safety requirements. Essential Job Functions and ResponsibilitiesOversee process development and manufacturing activities at external partnersEnsure that CDMO partners are adhering to quality and regulatory standards, product safety consistency, and compliance in the development of clinical materialsPrimary conduit between Avenzo and CDMO project management and technical teams on strategic and operational matters related to developing and manufacturing clinical supply materialsOversee and support by evaluating and ensuring integration of technical process development/CMC efforts into product plans and timelinesProvide technical expertise, problem solving and appropriate escalation on CMC matters including but not limited to, analytical development, process development, formulation development, data interpretation, shelf-life determination, quality control and quality assuranceEnsure the seamless transfer of technical information and supporting documents into Avenzo's regulatory submissions and related documentsLead and guide process characterization, validation studies, and if needed, technology transfer initiatives for ADC programs Prepare and review CMC sections of regulatory submissions, including INDs, BLAs, and MAAsDevelop a robust and reliable network of CMOs to enable seamless clinical manufacturingManage relationships with contract manufacturing organizations (CMOs) and ensure the successful execution of manufacturing campaigns from early phase clinical supply to process validation batchesWork closely with Quality, Regulatory Affairs, Clinical Operations, Program Management, and other departments to ensure seamless integration of CMC activities in the development plansBuild and lead a high-performing CMC team, fostering a culture of innovation, collaboration, and continuous improvementQualificationsPh.D. required, in Biochemistry, Protein Engineering or a related area degree preferred (e.g., MS, Ph.D.) with 15+ years of experience biopharmaceutical CMC development, with at least 5 years in a leadership role focused on ADCs in the pharmaceutical or biotechnology industry or an equivalent combination of academic and industry experienceDeep understanding of ADC development, including mAb, conjugation chemistry, process development, and analytical methodsProven track record in the design, development, optimization, and tech transfer of antibody or ADC manufacturing processesExtensive experience with regulatory requirements and submissions for biologics and ADCsProven ability to lead cross-functional teams and manage complex projectsExcellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholdersStrong analytical and problem-solving abilities, with a strategic mindsetAbility to travel as neededPhysical Demands and Work EnvironmentPhysical Demands:Constant or continuous use of a computer keyboard, monitor and mouse to perform a variety of tasksConstant or frequent sitting, standing or walkingMay lift and/or move objects of various weightsWork Environment:Hybrid; minimum three days per week in-office requirementNoise level in the work environment is usually moderateFast-paced, time sensitive environment with frequently changing prioritiesHandle multiple projects simultaneouslyReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. What We OfferCompetitive salary and discretionary bonus plan plus equityMedical, dental and vision insurance with 100% employer paid premiums for the employee coverage and 80% for family coverageEmployer-funded Health Savings AccountFlexible Spending AccountsGroup Life and AD&D insuranceVoluntary Life and AD&D insuranceShort-and Long-Term disability401(k) retirement planCritical Illness and Accident insuranceTime off, including 10 paid holidays, winter closure, PTO and sick timeA reasonable estimate of the base salary range for this role is $310,000-339,000. The final salary offered to a successful candidate will be dependent on several factors such as experience, education, skills and competencies. Avenzo Therapeutics is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex, gender, sex stereotype, gender identity, gender expression, transgender, sexual orientation, pregnancy, childbirth, breastfeeding or related medical condition, religious creed, physical disability, mental disability, age, medical condition, marital status, registered domestic partner status, military or veteran status, genetic information or characteristics, or any other characteristic protected by federal, state or local law. Avenzo Therapeutics also prohibits discrimination, harassment, disrespectful or unprofessional conduct based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.Notice to Search Firms/Third Party Agencies: Avenzo Therapeutics does not accept unsolicited resumes from recruiters or employment agencies without an executed search agreement in place.

Created: 2025-03-03