Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies (PMPD)
Company: Regeneron Pharmaceuticals, Inc.
Location: Tarrytown
Posted on: April 4, 2026
|
|
|
Job Description:
Regeneron's Preclinical Manufacturing & Process Development
group (PMPD), located in Tarrytown NY, is seeking a hardworking and
dynamic Staff Engineer for its Synthetic and Bioconjugation
Scale-up Technologies (SBST) group. In this exciting new role, you
will provide scientific leadership and support for synthetic
oligonucleotide process development using the principles of Quality
by Design (QbD), process scale-up, and technology transfer of
manufacturing-related workflows at Contract Development and
Manufacturing Organizations (CDMOs) to ensure timely and reliable
entrance to the clinic through product commercialization. A Typical
Day in the Role of Staff Engineer might include: Designing and
developing scalable, robust and controlled GMP-ready processes for
chemical synthesis of small-molecules. This includes purification
development and establishing supporting analytical characterization
techniques. Proactively complying to lab safety and environmental
safety expectations of both Regeneron and regulatory bodies such as
Food and Drug Administration (FDA), Department of Transportation
(DoT), etc. Ensuring a team-based evaluation of processes by
working closely with several groups such as R&D chemistry,
Formulations Development, Analytical Chemistry, and Protein
Biochemistry to ensure integrated program success. Generating
robust technology transfer documentation and supporting production
with onsite presence during scale-up/GMP manufacturing activities.
Partnering with External Manufacturing group and other key partners
at Regenerons IOPS organization to vet CDMOs and successfully
transfer processes with immediate, first-time success. Developing
new technologies for process improvements and predictive process
models, and pioneering novel at-line/in-line process analytical
technologies to ensure robust processing. Reviewing and providing
domain expertise for all regulatory submissions. Authoring
publications, reports, tech transfer documents, regulatory support
documents, patents. Performing long-term planning for laboratory
related personnel, supplies and equipment. This role may be for you
if you: Have strong initiative and aim to complete challenging
tasks and learn new technologies. Are capable of multi-tasking,
working both independently and within a team environment. Have
excellent interpersonal, verbal and written communication skills.
Can think critically and demonstrate problem-solving skills. This
role requires a Ph.D. or Masters in organic chemistry or a related
field. At least 3-6 years of industrial experience post-PhD or a MS
w/10 years, or BS with 15years in active pharmaceutical ingredient
(API) process development is preferred. Experience with
small-molecules in the bioconjugates space will be highly
preferable. Hands on experience with organic molecule synthesis and
characterization tools such as mass spectrometry, nuclear magnetic
resonance (NMR), infrared (IR) spectroscopy, high-performance
liquid chromatography (HPLC) etc. is preferred. Candidate must be
well-versed with purification techniques such as crystallization,
extraction, chromatography etc. Experience with solid-phase and
liquid phase peptide synthesis is preferable. Proven experience in
scaling-up synthetic small-molecule reactions and technology
transfer to a GMP manufacturing facility is a plus. Candidate
should be well-versed with International Council for Harmonization
(ICH)/regulatory guidelines and their impact on process development
of synthetic A typical day in the role of Staff Engineer might
include: Designing and developing scalable, robust and controlled
cGMP-ready processes for the chemical synthesis, purification, and
isolation of oligonucleotides across early and late-stage process
development. Ensuring a team-based evaluation of processes by
working closely with several groups such as R&D Chemistry,
Formulations Development, Analytical Chemistry, Protein
Biochemistry, CDMOs, and other key stakeholders to ensure
integrated program success. Generating robust technology transfer
documentation and supporting production with onsite presence during
scale-up/GMP manufacturing activities. Partnering with the External
Manufacturing group and other key partners at Regenerons Industrial
Operations and Product Supply (IOPS) organization to vet CDMOs and
successfully transfer processes with immediate, first-time success.
Promote new technologies for process improvements, predictive
process models, and novel at-line/in-line process analytical
technologies to ensure robust processing. Reviewing and providing
domain expertise for regulatory submissions. Authoring
publications, reports, tech transfer documents, regulatory support
documents, patents. Scientifically up-to-date on advances in
process chemistry and related disciplines Requires up to 20% travel
This role may be for you if you: Have strong initiative and aim to
complete challenging tasks and learn new technologies. Are capable
of multi-tasking, working both independently and within a team
environment. Have excellent interpersonal, verbal and written
communication skills. Can think critically and demonstrate
problem-solving skills. This role requires a Ph.D. or Masters in
organic chemistry or a related field. At least 5 years of
industrial experience post-PhD or at least 7 years of experience
post-Masters in active pharmaceutical ingredient (API) process
development is preferred. Experience with small-molecules in the
bioconjugates space will be highly preferable. Hands-on experience
with solid-phase oligonucleotide synthesis, purification, and
characterization using techniques such as mass spectrometry (MS),
nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, and
high-performance liquid chromatography (HPLC) is preferred. Proven
experience in scaling-up synthetic oligonucleotide syntheses and
technology transfer to a GMP manufacturing facility is a plus.
Candidate should be well-versed with International Council for
Harmonization (ICH)/regulatory guidelines and their impact on
process development of synthetic molecules and bioconjugates.
Experience in working with multi-functional Chemistry,
Manufacturing and Control (CMC) teams and experience in authoring
publications, reports, technical transfer documents, regulatory
support documents, patents is a plus. Note: title will be
commensurate with experience Does this sound like you? Apply now to
take your first step towards living the Regeneron Way! We have an
inclusive culture that provides comprehensive benefits, which vary
by location. In the U.S., benefits may include health and wellness
programs (including medical, dental, vision, life, and disability
insurance), fitness centers, 401(k) company match, family support
benefits, equity awards, annual bonuses, paid time off, and paid
leaves (e.g., military and parental leave) for eligible employees
at all levels! For additional information about Regeneron benefits
in the US, please visit
https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
For other countries specific benefits, please speak to your
recruiter. Please be advised that at Regeneron, we believe we are
most successful and work best when we are together. For that
reason, many of Regenerons roles are required to be performed
on-site. Please speak with your recruiter and hiring manager for
more information about Regenerons on-site policy and expectations
for your role and your location. Regeneron is an equal opportunity
employer and all qualified applicants will receive consideration
for employment without regard to race, color, religion or belief
(or lack thereof), sex, nationality, national or ethnic origin,
civil status, age, citizenship status, membership of the Traveler
community, sexual orientation, disability, genetic information,
familial status, marital or registered civil partnership status,
pregnancy or parental status, gender identity, gender reassignment,
military or veteran status, or any other protected characteristic
in accordance with applicable laws and regulations. The Company
will also provide reasonable accommodation to the known
disabilities or chronic illnesses of an otherwise qualified
applicant for employment, unless the accommodation would impose
undue hardship on the operation of the Company's business. For
roles in which the hired candidate will be working in the U.S., the
salary ranges provided are shown in accordance with U.S. law and
apply to U.S.-based positions. For roles which will be based in
Japan and/or Canada, the salary ranges are shown in accordance with
the applicable local law and currency. If you are outside the U.S,
Japan or Canada, please speak with your recruiter about salaries
and benefits in your location. Please note that certain background
checks will form part of the recruitment process. Background checks
will be conducted in accordance with the law of the country where
the position is based, including the type of background checks
conducted. The purpose of carrying out such checks is for Regeneron
to verify certain information regarding a candidate prior to the
commencement of employment such as identity, right to work,
educational qualifications etc. Salary Range (annually) $128,600.00
- $210,000.00
Keywords: Regeneron Pharmaceuticals, Inc., Clifton , Staff Engineer, Synthetic and Bioconjugation Scale-Up Technologies (PMPD), Science, Research & Development , Tarrytown, New Jersey