Process Engineer – Biotech Downstream/Tech-Transfer
Job Title: Process Engineer – Biotech Downstream/Tech-Transfer (JP14390)
Location: Cambridge, MA. 02138 / Hybrid or Remote
Employment Type: Contract
Business Unit: Internal and External PE
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Rate: $36 - $41/ hour W2 with benefits
Notes: This position can be Hybrid or Remote. Standard Business hours. Local to Cambridge MA or Thousand Oaks CA would be nice but not necessary.
Ideal Candidate
3+ years of industry experience, comfortable presenting. 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.
Job Responsibilities
- 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 Skills
Downstream Process, Tech Transfer, Scale-up
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
Red Flags
Predominant Upstream, Analytical or Drug Product experience
Interview Process
1on1 teams and Panel interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.