Scientist II, Analytical Development

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:

The Scientist II position within Analytical Development will be responsible for:

• Establishing HilleVax as a leader in vaccine analytical science through the application of processes, procedures, and technologies in the development of best-in-class vaccine testing strategies

• Developing methods to perform analytical characterization of new HilleVax vaccine candidates

• Leading the technical transfer and validation of methods to external laboratories in support of late-stage development and upcoming commercial testing of HilleVax's vaccine products

• Improve current methods to increase method robustness and over all assay performance

Responsibilities:

• As member of HilleVax Analytical Development department, work in on-site laboratory supporting internal Research and Development activities.

• Develop and execute innovative and/or cutting-edge technologies and strategies to wide range of methods including, but not limited to, liquid chromatography, electrophoretic techniques, and other analytical technologies relevant to the release and characterization of VLP-based vaccines

• Act as Subject Matter Expert (SME) for a range of methodologies.

• Provide leadership in the development, validation, and technical transfer of methods to Contract Testing Labs (CTL) for the release,stability, and characterization testing of HilleVax's vaccines

• Manage methods through their analytical life cycle and identify potential improvements for existing methods and develop remediation plans/timelines to align to overall corporate goals.

• Oversee the planning and execution of trending/tracking strategies for method monitoring

• Provide support for reagent sourcing/supply strategy

• Communicate technical information to Senior Management and external partners

• Represent the Analytical Development group in internal meetings and external interactions with vendor laboratories

• Write and review development and GxP technical documents and regulatory submissions

• Utilize external networks to identify, evaluate, and qualify potential partners for the performance of GMP assays and extended characterization

• Support preparation of relevant regulatory filings

Education, Experience & Skills:

• PhD with 3 years experience preferred or MS and a minimum of 5 years experience in vaccine or biologics method development, transfer, validation and/or release and stability testing in a Pharmaceutical setting

• Well-developed knowledge of cGMP practices as applicable to analytical development, technology transfer, and method validation is preferred

• Demonstrated technical expertise with practical hands-on experience multiple analytical methods, such as Reverse Phase and Size Exclusion HPLC, UV spectrometry, or electrophoretic techniques (e.g. SDS-PAGE, CE-SDS, iCIEF) is required

• Experience in biomolecular interaction analysis (Octet, SPR), molecular amplification technologies (ddPCR, qPCR), and/or flow cytometry is desirable

• Knowledge in the areas of Particle Size analysis (eg. FlowCam, NTA, MFI), MALS/DLS, DSC, SV-AUC, FTIR, electron microscopy, or mass spectrometry will be a key differentiator

• Proficiency in statistical software (JMP, R, etc.) for data analysis, tracking, and trending is highly desired.

• Internally motivated team player who can balance the needs of an entrepreneurial environment with the requirements of a structured GMP testing environment. Ability to balance attention to detail with an understanding of what is necessary vs. what is required.

• Good communicator who can present high technical information based upon audience composition

• Proven experience of working in a matrix environment is preferred

Travel, Physical Demands & Work Environment:

• Seeking Boston local candidates to be on-site 2-3 days per week, or more depending upon lab work required.

• Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).

• Typical office and laboratory bending, stooping, and lifting requirements.

• Lifting and moving supplies and equipment (up to 50lbs)

• Willingness to travel to various meetings or client sites, including overnight trips.

• Some international travel may be required.

• Between 10-15%.

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.