Director, Bioprocess Development
Company: Hillevax
Location: Boston
Posted on: April 19, 2024
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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, Cambridge , Director, Bioprocess Development, Executive , Boston, Massachusetts
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