Process Development Engineer/Synthetic

ACL Digital; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

ACL Digital in Cambridge, MA is seeking a Process Development Engineer for a 2-year contract to advance synthetic unit operations from kilo lab to pilot scale. The role emphasizes experimental design, modeling, data analysis and close collaboration with cross-functional teams to support technology transfer and commercial readiness.

The candidate will perform process characterization, risk analysis and equipment commissioning support, applying DOE and statistical tools to optimize purification,

Qualifications

• Master's degree or Bachelor's with 2 years experience, or Associate degree with 6 years, or high school diploma with 8 years.
• Experience in a process development/engineering environment for synthetics/small molecules.
• Experience building and using first-principles models (kinetics, mass transfer, separations, distillation, drying, hydrodynamics) across several modeling platforms.

Responsibilities

• Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization and scale-up of synthetic API in state-of-the-art facilities.
• Initiate and complete technical tasks in lab, kilo/pilot plant.
• Author documents for process understanding, transfer, risk assessment, facility fit and development/characterization.
• Serve as a technical expert for equipment or systems troubleshooting.
• Apply engineering principles and statistics, including DOE, to solve processing issues and evaluate improvement opportunities.
• Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
• Contribute to regulatory and quality activities such as non-conformance, process performance qualification and continued process verification.

Skills

Chemical Engineering

Process Development

First principles modeling

Education

Master's degree or Bachelor's with 2 years experience

Job description

Job Title: Process Development Engineer/Synthetics / Small molecule.

Location: Cambridge MA

Duration: 2 years contract

Description:

100% Onsite - Cambridge MA

Top 3 Must Have Skill Sets:

• Academic background in Chemical Engineering.
• Experience in a Process Development/Process Engineering environment for synthetics / small molecule.
• Experience building and utilizing first principal models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.

The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Amgen to develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and support of kilo lab operations during process execution and equipment commissioning.

Day to Day Responsibilities:

• Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the‑art facilities.
• Initiate and complete technical tasks in lab, kilo/pilot plant
• Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
• Function as a technical expert to equipment or systems regarding troubleshooting operations.
• Suggest problem resolution, provide troubleshooting guidance and recommend process improvements.
• Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements.
• Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
• Contribute to key regulatory and quality activities such as non‑conformance, process performance qualification and continued process verification.

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