Manager/Sr. Manager, Analytical Method Transfer And Validation

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

• Managing the validation and transfer of analytical assays for testing HilleVax's biologic vaccine products at external partner.

• Establishing HilleVax as a leader in biologic vaccine analytical science through the application of compliant and cutting edge processes, procedures, and technologies in the development of vaccine analytical testing strategies.

• Acting as a cross-functional point of contact and subject matter expert on the analytical control strategy in the technical operations organization in order to promote scientific and operational excellence.

• Overseeing, developing, and managing external and internal cross-functional activities and relationships required to advance HilleVax's vaccine manufacturing goals.

Responsibilities:

• Managing the establishment, qualification, validation, and technical transfer of analytical assays for release, stability, and characterization testing of HilleVax's biologic vaccine products at contract testing and manufacturing organizations.

• Technical authorship and review of test methods, protocols, data packages, and reports associated with Phase III and pre-commercial assay transfer and validation, as well as the associated regulatory IND and BLA sections.

• Acting as an effective analytical development point of contact for multiple third party manufacturing and testing labs by fostering productive communication and collaboration between relevant internal and external technical teams.

• Supporting functional experts and quality control/assurance in analytical testing, reference standard, and stability deviation impact assessments and investigations.

• Communicating technical information to internal and external stakeholders, as well as senior management and external partners.

• Utilizing external networks to identify, evaluate, and support qualification of external partners for the executions of GMP assays.

• Interfacing with regulatory agencies and national laboratories on analytical testing strategies to advance licensure of HilleVax's vaccines.

Education, Experience & Skills:

• PhD and a minimum of 4 years experience or MS and a minimum of 6 years experience in vaccine or biologics GMP assay development or transfer/validation is preferred.

• The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a structured GMP testing environment.

• Proven experience in managing and coordinating biologics or vaccine analytical transfer, validation, testing, and contracts with external partners.

• Demonstrated technical expertise in an analytical discipline related to biologics or vaccine assay development.

• Well-developed knowledge of cGMP practices as applicable to formulation, analytical development, technology transfer, and manufacturing.

• Established external network of service providers, technical experts, suppliers, and technology providers.

• Proven experience in a matrix environment is preferred.

• Demonstrated ability to work efficiently across multiple project teams and business functions.

Travel, Physical Demands & Work Environment:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

• Up to 20-25% travel.

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.