Director, Analytical Science and Assay Development

 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.  

Position Description

Job Title: Director, Analytical Science and Assay Development

Location: IAVI Headquarters, New York, New York, USA

Reports to:      Executive Director, Product Development and Manufacturing

Position Summary:

IAVI is seeking a Director, Analytical Science and Assay Development who will strategize and lead activities for the development of candidate vaccines and biologics important to human health for prophylactic and/or therapeutic use. This position will address analytical needs of transitioning recombinant protein products / monoclonal antibodies and viral vectors from discovery into clinical testing.   

 An ideal candidate will have strong communication skills and able to interact in an influential way with key stake holders within IAVI and external collaborators and CMOs, as well as have an understanding of biochemical and biophysical principles underpinning various protein analytical methods.   

Key Responsibilities:

• Advise the relevant internal stakeholders with the FDA, EMA, ICH, WHO regulatory and pharmacopeia guidelines and compliance requirements for biologics.
• Develop and implement evolving analytical packages that spans all the way through from research to a regulated compliance environment (R&D and GXP) 
• Build assay packages that ensures product CQA is maintained during expression, purification, and storage of DS and DP of biologics.
• Translate research techniques into SOPs for tech transfer
• Participate within the Product Development Project teams and develop technical work plans through different phases of development through to cGMP manufacturing and product release to support IND enabling activities. 
• Collaborate on grant applications, writing grants, and developing budgets to secure funding. 
• Author and review technical and scientific documents including but not limited to method development reports, qualification/ validation protocols and reports, SOPs, and test methods.
• Author and review CMC IND sections for regulatory submission.
• Maintain analytical data integrity in compliance with industry good documentation practices (GDP)
• Ensure that testing methodologies meet phase-appropriate cGMP requirements.
• Work with internal subject matter experts to write and review analytical test method, protocols, and development reports.
• Perform any other duties as assigned by the Manager.

Education and Experiences: 

• PhD in analytical chemistry or a related field is required.
•  Minimum 10 years of experience in biologics CMC development, vaccine development, and outsourcing pharma bioanalysis is required.

 Qualifications and Skills:

• A strong background in cGxP (e.g. GRP, GMP, GLP) is required.
• Experience with the testing of Vaccines and Therapeutics, consistent with International Standards e.g. ICH, US FDA and EMA requirements is required.
• Experience working in an FDA Regulated Environment (Pharmaceuticals or Biologics) for analytical development of cGMP biologicals for pre-clinical, and clinical evaluation is required. 
• Experience in developing and qualifying large molecule analytical methods including HPLC, capillary electrophoresis (CE), and biologics characterization is required.
• Experience with the development of standard analytical tests (e.g. SDS-PAGE, western blots, ELISA, SPR, Biacore, Isoelectric focusing, quantitative PCR, immunoassay platforms) is required.
• Experienced and trained in biophysical assays such as Mass Spectrophotometry, Glycan analysis, SEC-MALS, Cryo-EM, CD, DSC and AAA Analysis pertaining to product development is required.
• Understanding of and experience in writing SOPs is required.
• Familiarity with negotiating contracts with the CMOs & CROs along with the Legal and Grants/Contracts & Compliance is required.
• Understands and has the ability to develop and implement an evolving analytical package that spans all the way through from research to a regulated compliance environment (R&D and GXP) is required.
• Understands the scientific principles underpinning the critical quality attributes (CQA) of drug substance (DS) and drug product (DP) is required.
• Experienced in building an assay package that ensures that CQA is maintained during expression, purification, and storage of DS and DP of biologics is required.
• Technical understanding of Vaccines and Therapeutics development and knowledge of Quality Assurance (QA) considerations for cGxP activities is required.
• Excellent verbal, written, and presentations skills are required.
• Track record of working in a multi-cultural environment with the ability to influence and generate consensus is required.
• Experience with technical transfer of analytical tests and oversight of CMOs/CROs are highly desirable. 

Organizational Overview:

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.