As an organization whose mission is to translate science into global public health impact , working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.
AssociateDirector, CMC Recombinant Protein DevelopmentLocation:
IAVI Headquarters, New York, New York, USA or RemoteReports to:
Senior Director, CMC Development
IAVI is seeking a highly motivated vaccine sciences professional to join our Chemistry Manufacturing and Controls (CMC) team as an Associate. Director, CMC Recombinant Protein Development. Focusing on recombinant protein subunit vaccines, this position will engage closely with IAVI team members, program stakeholders, academic partners, and CRO/CDMOs to advance novel vaccine candidates from research into Phase1/2 clinical trials. The successful candidate will also work with IAVI team members to assess and implement new vaccine production/analytical/delivery technologies (such as mRNA-based vaccines, adjuvants and delivery devices) and enhance the capabilities of IAVI's CMC Team.
- In collaboration with the IAVI team and program partners, create technical work plans through different phases of vaccine CMC development (cell line, upstream, downstream, analytical and formulation) through to cGMP manufacturing and product release for pre-clinical & clinical studies.
- Play a role in assessing the developability of new recombinant protein vaccine candidates.
- Assist in the selection of Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs) for generation of high expression cell lines, cGMP manufacturing, and release and stability testing of protein-based vaccine candidates within the R&D portfolio as per Regulatory requirements.
- Establish operational work-plans with the CMOs & CROs, providing technical leadership and oversight of the program with an emphasis on technical guidance and troubleshooting, monitoring timelines and budget, and working closely with the project team.
- Provide constructive input into the contracts with the CDMOs & CROs along with the IAVI Legal, Business Administration, Grants/Contracts & Compliance, and QA departments.
- Perform other duties as assigned by the manager
Education and Experience:
- PhD in biochemistry, chemistry, engineering sciences or a related field is required.
- Minimum 6 years of industrial experience in vaccine development with a focus on CMC development for protein subunit vaccines.
- Minimum 2-3 years of direct managerial experience (project leadership or people management) is required' experience managing vaccine CMC development and cGMP manufacturing work at CROs and CDMOs is a plus.
Qualifications and Skills:
- Experience in process and analytical development of protein subunit vaccines with clear demonstration of product development expertise and CMC knowledge is required.
- Strong technical knowledge of mammalian expression systems and production, as well as troubleshooting on issues related to process and product development of recombinant proteins, cGMP manufacturing, and testing is required.
- A strong background in cGxP (e.g. cGMP, cGLP) and working in an FDA Regulated Environment (Pharmaceuticals or Biologics) for developing high expression cell lines, undertaking process and analytical development, and cGMP Manufacturing of biologicals for pre-clinical and clinical evaluation is required.
- Familiarity with development of vaccines and other biologics, consistent with International Standards e.g. ICH, US FDA and EMA requirements is required.
- Sound technical understanding of biological development and knowledge of Quality Assurance (QA) considerations for cGxP activities is required.
- Familiar with negotiating contracts with the CDMOs & CROs and dealing with the Legal, Business Administration, Grants/Contracts & Compliance and QA departments.
- Demonstrated leadership ability and organizational skills to manage highly complex technical programs with multiple partner institutions and stakeholders, including government, academic, non-profit, biopharma and CDMO/CROs.
- Excellent verbal, written, and presentation skills are required.
- Ability to work with staff at all levels internally and externally, is required.
- Proven record of working in a multi-cultural environment, and proven ability to influence and generate consensus is required.
- Technical experience with mRNA-based vaccines is highly desirable.
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., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.
Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, 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 as a scientific global non-profit. IAVI upholds these principles through IAVI's Global Diversity and Inclusion Committee.
IAVI has zero tolerance 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 and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.