Process Development Engineer, Biopharma Drug Substance; JP

Position: Process Development Engineer, Biopharma Drug Substance (JP13190)
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 sendyour resume to Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role. #J-18808-Ljbffr