Process Development Associate – Process Engineering & Sterile Manufacturing

About the role

We are seeking an early-career Associate Scientist/Lab Technician II to support process engineering, continuous improvement, and laboratory activities within a sterile drug product manufacturing environment.

Responsibilities

• Support laboratory studies involving sterile drug product processes, including formulation and filtration activities.
• Affiliate with process engineering and continuous improvement initiatives designed to improve quality, yield, throughput, cycle time, capacity, and cost.
• Investigate manufacturing and process-related challenges using structured problem-solving and scientific principles.
• Collect, analyze, and interpret process data to identify trends and improvement opportunities.
• Use statistical tools such as Minitab to support process monitoring and data analysis.
• Participate in change-request assessments and evaluate the potential impact of process, material, or technology changes.
• Write technical reports, scientific summaries, justification memos, protocols, and other documentation describing laboratory studies and experimental outcomes.
• Support process validation activities, including operational changes, new raw materials, and the introduction of new processes or technologies.
• Assist with experimental, demonstration, and validation lots.
• Maintain accurate and compliant laboratory and manufacturing documentation.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, Operational Excellence, and EHS teams.
• Provide responsive laboratory and technical support for changing manufacturing priorities and time-sensitive activities.
• Follow applicable GMP, safety, environmental, and regulatory requirements.

Requirements

• Associate, bachelor’s, or master’s degree in a scientific or engineering discipline.
• Degrees in Chemistry, Biology, Chemical Engineering, Biochemical Engineering, Bioengineering, Biomedical Engineering, or a related field are especially relevant.
• Previous hands-on laboratory experience through employment, internships, co-ops, or academic research.
• Interest in process engineering, pharmaceutical manufacturing, validation, technical operations, or continuous improvement.
• Ability to document experiments and communicate scientific findings through clear technical reports and memos.
• Strong organizational skills and the ability to adjust priorities in a dynamic, responsive environment.
• Effective written and verbal communication skills.
• Ability to work both independently and collaboratively after completing training.

Qualifications

• Recent graduates with relevant laboratory experience are encouraged to apply.
• Previous pharmaceutical or manufacturing experience is preferred, but applicable internships, academic research, validation exposure, or technical operations experience will also be considered.

Skills

• Hands-on laboratory experience.
• Structured problem-solving and scientific principles.
• Statistical tools such as Minitab.
• Clear technical reports and memos.
• Collaborative team work.
• Compliance with GMP, safety, environmental, and regulatory requirements.

Benefits

• Medical benefits available at a cost.

Pay

$20 - $23 per hour

Schedule

Monday–Friday, standard business hours