Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer - REMOTE

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 Job Description 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.

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 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory. Basic Qualifications Master's degree.

Bachelor's degree and 2 years of Engineering or Operations experience. Associate's degree and 7 years of Engineering or Operations experience. 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 Teams screening first. 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. #J-18808-Ljbffr