Director, Bioprocess Development

Company: Hillevax
Location: Boston
Posted on: April 19, 2024

Job Description:

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 achieved
significant milestones this year, including the completion of NOR-212, a Phase 2b clinical trial of
HIL-214 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:
Hillevax is seeking a Bioprocess development leader to lead, development of scalable processes for
CMC development of its early-stage clinical programs. This position will have primary
responsibility for scientific leadership and technical oversight of upstream and downstream process
design, development and scalability of unit operations necessary for supporting the Target product
profile of the vaccine candidates in development. This role is within a team of highly experienced
scientists with an opportunity to drive IND submission of early-stage assets.
As one of CMC development lead, the individual will apply their strong expertise in CMC
fermentation and /or purification to develop robust, phase-appropriate processes for drug substance
GMP production to enable human clinical studies and eventual licensure.
The individual may also be involved in the technical transfer, GMP readiness to ensure timely
availability of clinical supplies manufactured at the Contract Manufacturing Organization (CMO).
This individual will work with a cross functional team across Tech Ops, including CMC Development,
MSAT, Supply Chain, and Analytical Development teams. They will be a member of the core program
team representing Tech Ops and will partner with other leaders to drive and lead implementation of
CMC project strategies and comprehensive project plans to further
the early stage CMC development of the new vaccine candidates.

Experience with phase appropriate development, cGMP operations, and regulatory expectations is
essential for success., Cell culture, microbial fermentation, Chromatography design, use of QbD and
PAT approaches, scale-up and development experience is strongly desired, including understanding of
the underlying engineering principles. This individual must be proficient in design of experiments,
statistical tools for analysis and interpretation of data, and electronic data management systems.
The ideal candidate will also have familiarity with different biologics modalities and large-scale
production systems for manufacture of therapeutic proteins.
This position is an onsite role in a lab-based function. To be successful candidates must enjoy and
thrive in an onsite, highly collaborative lab environment with daily face-to-face cross- functional
interactions between scientists.

Responsibilities:

Effectively function as a CMC lead generating original technical ideas and development strategies.
--- Provide scientific and technical leadership of early-stage assets to design and develop scalable
upstream and downstream processes using QbD and PAT tools.
--- Responsible for development, characterization, scale-up and support of drug substance processes
to enable advancement of programs.
--- Develop robust CMC development plans, Apply established platform approaches and problem-solving
skills to rapidly tackle drug substance challenges and build robust processes with efficient
experimentation
--- Expand and develop skills in microbial fermentation, scale up and purification, thereby further
contributing to the integrated group.
--- Participate in drug substance teams and collaborate cross functionally with analytical and drug
product representatives to deliver drug substance manufacturing processes in a phase appropriate
manner.
--- Make significant contributions to project team through lab-based activities.
--- Proactively seek out new tools, techniques, and strategies to implement into individual
programs(s)
--- Be hands-on and execute lab and small-scale operations to meet project deliverables.
--- Transfer processes to GMP manufacturing .
--- Write technical publications, reports, presentations, and regulatory filings including
publishing research in peer-reviewed journals and presenting work at scientific conferences.
--- Work efficiently, collaboratively, and cross-functionally toward project timelines and
goals.
--- Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP
manufacturing environment.
--- Provide technical recommendations for evaluating process data, troubleshooting and root cause
analysis as well as providing strategic recommendations leading to improved yields, cost of goods
and process robustness.
--- Identify and lead additional development activities and manufacturing through various phases of
product development.
--- Participate in efforts to define, manage, and/or complete innovation projects that advance
technical capabilities, refine & establish platform manufacturing processes.
--- Generate documentation for experimental reports to support technology transfer and regulatory
filings (development and technical report writing).
--- Communicate technical information and project progress to the Senior leadership and external
partners.
--- Mentor/supervise a team of one or more and evaluate the performance of those individuals; is
accountable for the effective performance of the team/individuals.
Preferred Qualifications:
--- Must be a subject matter expert in microbial fermentation (yeast). Additional experience in
downstream purification of biologics including chromatography separations and filtration operations
(depth, dead-end, and ultrafiltration/diafiltration) is a plus.
--- Direct experience in designing, planning and executing feed strategies for increased yield and
productivity,
--- Proficiency in Mandarin
--- Strong understanding of analytical techniques using HPLC, ELISA and mass spectrometry- based
methods

Education, Experience & Skills:
--- PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 8
years in the bio/pharmaceutical manufacturing environment. MS with 10+ years of relevant experience
in MSAT or process development of biologics /vaccines may also be considered.
--- Direct experience in microbial expression systems (yeast) is a must.
--- Technical expertise in development and full-scale manufacture of recombinant biologic products.
Direct experience in Vaccine development and Phase 1-3 readiness support is highly desirable.
--- Excellent communication skills, both written and oral.
--- Proficiency in statistical software for data analysis and tracking and trending.

Travel Requirements:
--- Seeking Boston local candidates to be on-site 3-4 days per week.
--- Travel (5-10%) may be required to CMO, CRO and key vendor for process and product development
purposes.

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.


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Keywords: Hillevax, Plymouth , Director, Bioprocess Development, Executive , Boston, Massachusetts