Process Development Engineer, Biopharma Drug Substance

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 . 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 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