Process Development Engineer, Biopharma Drug Substance (JP13190)
Company: 3 Key Consulting
Location: Cambridge
Posted on: April 1, 2026
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Job Description:
Job Title: Process Development Engineer, Biopharma Drug
Substance (JP13190) Location: Cambridge, MA 02138 (Hybrid or
Remote) Business Unit: Pilot Plant Operations Employment Type:
Contract Duration: 6 months with likely extensions or conversion to
perm Rate : 38-42$/hours W2 with benefits Posting Date: 09/20/2024
Target Start Date: 11/11/2024 Notes: Hybrid or Remote. EDT Standard
Business hours 3 Key Consulting is hiring! We are recruiting an
Engineer for a consulting engagement with our direct client, a
leading global biotechnology company. Ideal Candidate : 3-4 years
of industry experience, comfortable presentation. Biologics/ drug
substance purification experience required (Chromatography,
filtration, UFDF unit ops) Knowledge of purification
processes/equipment; scale-up factors, process deviations, quality
attributes. GMP experience is a huge plus. Job Description: Seeking
a Process Development Engineer to join the Drug Substance
Technology Engineering team at our Cambridge site. Providing strong
process engineering/ technology transfer support of human
therapeutic products in clinical development through commercial
production. Our mission is to translate developmental processes to
commercial reality for patients through scientific expertise and
engineering innovation. The Engineer will apply cell culture and
purification process engineering knowledge in support of technology
transfer and clinical/commercial drug substance manufacturing in
both stainless and single-use formats. Will partner with
manufacturing, quality, analytical, and bench scientists to support
a highly dynamic technology transfer. Responsibilities include :
Under guidance of senior staff, the Engineer performs the
following: Transfer purification processes for drug substance
manufacturing and translate process improvements from the
laboratory into manufacturing facilities Provide technical support
for successful scale-up, transfer of process technology, and for
clinical and/or commercial manufacturing operation Assist in
troubleshooting clinical and commercial runs Execute data trending
and statistical process analysis Support technical direction for
process-related deviations, CAPAs, and change controls Identify and
support process-related operational excellence opportunities
Represent process development and collaborates with other functions
such as Manufacturing, Quality, and Regulatory Top Must Have Skill
Sets: Purification/"downstream" laboratory (PD) or MFG experience
with monoclonal antibodies, chromatography, filtration, UFDF,
UF/DF, final fill, viral filtration, viral inactivation. Technology
Transfer/NPI experience is a plus. PPQ experience is a plus Basic
Qualifications: Master degree OR Bachelor degree and 2 years of
experience OR Associate degree and 6 years of experience OR High
school diploma / GED and 8 years of experience Employee Value
Proposition: Gain Biopharma experience. Red Flags: Initial duration
of 6 months subject to longer extensions Not looking for a recent
graduate - the team is looking for a candidate who can join the
team and make an impact. Interview Process: At least two per
candidate (one by myself or with my manager, another with a couple
more team members.) Phone/Teams is easiest. We invite qualified
candidates to send your resume to recruiting@3keyconsulting.com .
If you decide that you’re not interested in pursuing this
particular position, please feel free to take a look at the other
positions on our website www.3keyconsulting.com/careers. You are
also welcome to share this opportunity with anyone you think might
be interested in applying for this role. Regards, 3KC Talent
Acquisition Team
Keywords: 3 Key Consulting, Middletown , Process Development Engineer, Biopharma Drug Substance (JP13190), Healthcare , Cambridge, Connecticut
