Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Upstream/Downstream Drug Substance Process
Development & Tech Transfer – REMOTE (JP15076) Location: Thousand
Oaks, CA. 91320 (100% Remote) Employment Type: Contract Business
Unit: Drug Substance Technology Engineering Duration: 1 year (with
likely extensions and/or conversion to permanent) Posting Date:
03/5/26 Pay Rate: $36 - $41/hour W2 Notes: Only qualified
candidates need apply. Remote - EST preferred - Open to all US
remote candidates 3 Key Consulting is hiring an Engineer,
Upstream/Downstream Drug Substance Process Development for a
consulting engagement with our direct client, a leading global
biopharmaceutical company. Job Description: Our ideal candidate
will have 3 years of experience in tech transfer of Biologics Drug
Substance upstream and/or downstream required (Cell Culture,
Harvest, Chromatography, filtration, UFDF unit ops), Knowledge of
upstream and downstream processes/equipment; scale-up factors,
process deviations, quality attributes. GMP or lab experience is a
nice to have. Strong problem solving and troubleshooting experience
would be a plus. Seeking a Process Development Engineer to join the
Drug Substance Technology Engineering team at our client’s
Cambridge, MA. 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 process engineering knowledge in support of
upstream and/or downstream 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. Why is the Position Open? Supplement to the
teams ongoing needs. Top Must Have Skills: At least 2 years of
Biologics / Drug Substance tech transfer experience required (Cell
culture/ harvest/ Chromatography/ filtration/ UFDF unit ops). At
least 2 years of experience in the lab scale development work or in
the manufacturing environment (pilot plant or GMP) Strong
analytical capability, troubleshooting, and problem solving skills
Day to Day Responsibilities: Under guidance of senior staff, the
Engineer will perform the following: Transfer 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 Basic
Qualifications: Master’s degree OR Bachelor’s degree and 2 years of
Engineering or Operations experience Associate’s degree and 7 years
of Engineering or Operations experience OR High school diploma /
GED and 8 years of Engineering or Operations experience Preferred
Qualifications: Master’s Degree in Chemical or Biochemical
Engineering 1 years of Process Engineering experience preferably
related to upstream and/or downstream purification of commercial
cGMP manufacturing facilities Background in biologics technology
transfer into commercial facilities, new product introductions
(NPIs) Biologics process knowledge: Knowledge of processes (cell
culture, harvest, chromatography, viral filtration/inactivation,
ultrafiltration/diafiltration, and final fill) and equipment;
scale-up factors, process deviations, quality attributes Strong
analytical capability, troubleshooting, and problem solving
Independently motivated with ability to multi-task and work in
teams, especially if remote or hybrid. Excellent written and verbal
communication skills with technical writing and presentation
experience Red Flags: Too much experience (15 years) Many job
changes within a year or less Interview process: 1. Teams screening
first 2. Panel interviews second We invite qualified candidates to
send your resume to resumes@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, Pico Rivera , Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076), Engineering , Thousand Oaks, California
