Process Development Engineer

SSi PeopleCambridge / Massachusetts

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Job Title : Process Development Engineer

Location : Remote

Job Summary :

We are seeking a Process Development Engineer to support the transfer and optimization of purification processes for biologics drug substance manufacturing. In this remote role, you will collaborate with cross-functional teams to ensure efficient, compliant, and scalable operations for both clinical and commercial production. Your expertise in downstream processing, technical troubleshooting, and data analysis will be essential to driving successful process development and tech transfer initiatives.

Job Responsibilities :

Transfer purification processes for drug substance manufacturing and implement lab improvements in manufacturing facilities.

Provide technical support for scale-up and technology transfer for clinical and commercial manufacturing operations.

Assist in troubleshooting clinical and commercial production runs.

Conduct data trending and statistical process analysis.

Support process-related deviations, CAPAs, and change controls.

Collaborate with Manufacturing, Quality, and Regulatory teams to identify operational excellence opportunities.

Skills Required :

3+ years of industry experience, with expertise in biologics / drug substance purification (Chromatography, filtration, UFDF unit ops).

Strong knowledge of purification processes, equipment, and scale-up factors.

Experience with process deviations and quality attributes.

Familiarity with GMP is a plus.

Comfortable presenting and working in a team environment.

Ability to support technology transfer and manufacturing processes.

About SSi People :

With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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Development Engineer • Cambridge/ Massachusetts