Vice President, Head of Bioprocess Development & Manufacturing

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: Vice President, Head of Bioprocess Development & Manufacturing

Location: Hybrid IAVI Office locations - New York, NY, USA; Nairobi, Kenya; Amsterdam, Netherlands; Cape Town, South Africa; Remote options will be considered

Reports to: Vice President, Product Development

Position Summary:

Are you a passionate Life sciences manufacturing leader in who’s eager to translate science into global health solutions? If you are a GMP manufacturing expert with extensive leadership experience as well as vaccine experience, learn more and apply below!

IAVI is seeking an Experienced Leader who has depth of expertise in all phases of manufacturing processes, including drug substance, drug product, and development of analytical control strategies. The Head of Manufacturing is accountable for process design, leading internal and external partners to establish critical quality attributes of drug substance, drug product, qualifying raw materials throughout the R&D life-cycle. The Head of Manufacturing is a GMP expert, as well as a seasoned leader who drives strategic decisions impacting the scale-up and development of best-in-class vaccines and treatments.

Key Responsibilities:

• Accountable for product and process development, scientific and engineering quality, and ensures all product quality attributes are understood and controlled through manufacturing and analytical controls.
• Partners with leadership on cross-functional teams to deliver and maintain processes and controls that are timely, phase-appropriate, and compliant, to meet clinical and commercial supply needs.
• Understands and responds to business priorities and translates these into tactical objectives and work direction.
• Mitigates risks to production schedules and program deliverables when necessary and ensures an effective tech transfer/process.
• Develops and executes a plan for validating the manufacturing process for IAVI’s portfolio of programs, each at various stages of development.
• Work with functional expertise throughout IAVI to conduct risk assessments for critical processes and develop mitigations plans.
• Collaborate with internal and external partners to develop and validate plans for at-scale production and drive the execution of these plans.
• When required, define protocols for tech transfers and facilitate evaluation and processes to ensure successful design of production, ensuring GMPs are fully integrated.
• Work with internal stakeholders (e.g., Regulatory) to ensure validation strategies fit within IAVI and our funders strategy.
• Collaborate with project management to maintain a detailed timeline for the activities that must be completed – communicate to team when activities are at risk of causing delays to timeline.
• Manage manufacturing to support commercial production.
• Understand process and analytical requirements for the entire process.
• Communicate process requirements to facilities engineers fit for purpose design.
• Creatively apply experience to ensure process design specifications are met on time and with high quality standards.
• Manage contract manufacturing oversight activities, such as reviewing of pre-campaign documentation, batch records, deviations, and approving batch release documentation.

Education and Work Experience:

• Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field is required.
• Minimum of 15 years’ experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years’ senior management experience.
• Experience in early and late-stage product development, ideally having successfully been involved with bringing a product(s) to licensure.

Qualifications and Skills:

• Prior vaccines manufacturing experience is required.
• In depth experience with technology transfer and process validation is required.
• Experience overseeing CMOs and partnering with these organizations to drive results is required.
• Ability to dissect a manufacturing issue, conduct root cause assessments, and design experiments to test hypotheses stemming from manufacturing observations.
• Strong ability to motivate, mentor, and connect with peers and team members.
• Experience with CRO oversight, ensuring compliance with relevant regulatory standards required.
• Experience successfully managing and utilizing project management tools
• Ability to work across teams and SMEs to integrate information into centralized plans.
• Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
• Strong interpersonal skills, with excellent written and verbal communication skills.
• Ability to travel domestically and internationally as needed.
• A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals.

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.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

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.

Compensation and Benefits Information for US-Based Candidates:

Annual base salary for this position is: $260,000.00 - 325,000.00

Compensation And Benefits Information for NON-US Based Candidates:

Salary is paid in local currency, and is commensurate and competitive with the local labor market

Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.