Associate Director, CMC
Not Disclosed•Full-TimeRemote
location_on45, West 10th Street, Greenwich Village, Manhattan, New York County, New York, 10011, United States
About IAVI
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., we pioneer the development of biomedical innovations designed for broad global access.
Our approach emphasizes sustainability and is grounded in the regions where disease burdens are greatest. We develop vaccines and antibodies in and for the developing world, seeking to accelerate their introduction in low-income countries. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training of the next generation of scientists. By fostering unique collaborations among academia, industry, local communities, governments, and funders, we accelerate scientific discovery to address public health threats that disproportionately affect people living in poverty.
About the Role
As an Associate Director, CMC Recombinant Protein Development, you will join our Chemistry Manufacturing and Controls (CMC) team to advance novel vaccine candidates from research into Phase 1/2 clinical trials. Focusing on recombinant protein subunit vaccines, this position serves as a critical bridge between scientific innovation and manufacturing reality.
You will engage closely with IAVI team members, program stakeholders, academic partners, and CRO/CDMOs to drive technical work plans through all phases of vaccine CMC development. Beyond immediate project execution, you will work with the team to assess and implement new vaccine production, analytical, and delivery technologies, including mRNA-based vaccines, adjuvants, and delivery devices, to enhance the capabilities of IAVI's CMC team. This role offers the opportunity to apply your expertise in a mission-driven environment where your work directly contributes to saving lives globally.
Hiring Process
Candidates selected for an interview will be contacted directly by the hiring team to schedule a series of discussions. The process typically includes an initial screening to discuss background and role fit, followed by technical deep-dives and team collaboration sessions. Finalists will meet with senior leadership to discuss strategic alignment and organizational culture before an offer is extended.
Equal Opportunity & Culture
IAVI is an equal opportunity employer actively committed to fostering a diverse and inclusive global organization. We believe that diversity and inclusion among our teammates are critical to our success, and we seek to recruit, develop, and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues' experiences and believe that dedication to our mission above all is essential to our success.
IAVI upholds these principles through its Global Diversity and Inclusion Committee and maintains a zero-tolerance policy for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status. We consider qualified applicants regardless of these protected statuses in any of our locations worldwide.
Vaccination Policy
As part of our commitment to a safe and healthy work environment, IAVI requires all U.S. and Puerto Rico-based employees to be vaccinated for COVID-19, subject to applicable law. We support all employees during this process and provide accommodations for approved medical or religious exemptions.
Work location
Work model: Remote
45, West 10th Street, Greenwich Village, Manhattan, New York County, New York, 10011, United States
New York, New York
Key Responsibilities
- check_circleCreate technical work plans for vaccine CMC development phases through cGMP manufacturing and product release
- check_circleAssess the developability of new recombinant protein vaccine candidates
- check_circleProvide input into contracts with CDMOs and CROs in collaboration with legal and compliance departments
- check_circleSelect CROs and CMOs for cell line generation, cGMP manufacturing, and stability testing
- check_circleEstablish operational work plans with CMOs and CROs while providing technical leadership and oversight
- check_circleMonitor program timelines and budgets while troubleshooting process and product development issues
Requirements
- verifiedPhD in biochemistry, chemistry, engineering sciences or related field
- verifiedMinimum 6 years industrial experience in vaccine development with focus on CMC for protein subunit vaccines
- verifiedMinimum 2-3 years direct managerial experience
- verifiedExperience in process and analytical development of protein subunit vaccines
- verifiedStrong technical knowledge of mammalian expression systems and cGMP manufacturing
- verifiedBackground in cGxP (cGMP, cGLP) and FDA regulated environment
- verifiedFamiliarity with ICH, US FDA, and EMA requirements
- verifiedExcellent verbal, written, and presentation skills
- verifiedAbility to work in multi-cultural environment
- verifiedCOVID-19 vaccination required for US and Puerto Rico based employees
Nice to Have
Experience managing vaccine CMC development and cGMP manufacturing work at CROs and CDMOs. Technical experience with mRNA-based vaccines.
Similar Job Opportunities
Skills, education and keywords
Skills: CGMP, CGLP, CGXP, Ich, Fda, Ema, Mrna-Based Vaccines, Recombinant Protein, Mammalian Expression Systems, Cell Line Development.
Education: PhD in biochemistry, chemistry, engineering sciences or related field required.
Frequently asked questions about Associate Director, CMC at IAVI
What does a Associate Director, CMC at IAVI do?expand_more
A Associate Director, CMC at IAVI is responsible for the following: Create technical work plans for vaccine CMC development phases through cGMP manufacturing and product release; Assess the developability of new recombinant protein vaccine candidates; Provide input into contracts with CDMOs and CROs in collaboration with legal and compliance departments; and Select CROs and CMOs for cell line generation, cGMP manufacturing, and stability testing.
What are the requirements for this Associate Director, CMC role?expand_more
IAVI is looking for candidates who meet the following requirements: PhD in biochemistry, chemistry, engineering sciences or related field; Minimum 6 years industrial experience in vaccine development with focus on CMC for protein subunit vaccines; Minimum 2-3 years direct managerial experience; Experience in process and analytical development of protein subunit vaccines; Strong technical knowledge of mammalian expression systems and cGMP manufacturing; and Background in cGxP (cGMP, cGLP) and FDA regulated environment.
Where is the Associate Director, CMC role at IAVI located?expand_more
Associate Director, CMC at IAVI is based in 45, West 10th Street, Greenwich Village, Manhattan, New York County, New York, 10011, United States. This is a remote role.
Is this Associate Director, CMC job remote, hybrid, or on-site?expand_more
IAVI has listed this Associate Director, CMC role as remote.
How much experience is required for this Associate Director, CMC role?expand_more
Associate Director, CMC at IAVI typically requires 6+ years of relevant experience at the lead level.
What skills do you need for the Associate Director, CMC role at IAVI?expand_more
Key skills for Associate Director, CMC at IAVI include CGMP; CGLP; CGXP; Ich; Fda; Ema; Mrna-Based Vaccines; and Recombinant Protein.
What education is required for Associate Director, CMC at IAVI?expand_more
Educational requirements for this role: PhD in biochemistry, chemistry, engineering sciences or related field required.
What category does the Associate Director, CMC role belong to?expand_more
Associate Director, CMC at IAVI is part of the scientific & qa job category on Recrutus.