Process Development Engineer I

Our client, an innovative biotechnology company focused on developing therapies for neurodegenerative diseases, is seeking a Contract Manufacturing Science and Technology (MSAT) Engineer to support cell culture operations within their early-stage Technical Operations organization. This individual will contribute to lab-scale process execution, technology transfer activities, data analysis, and technical documentation in support of advancing biopharmaceutical manufacturing processes.

This is an excellent opportunity for an early-career engineer to gain hands-on experience in MSAT, process scale-up, and technology transfer within a collaborative and fast-paced biotechnology environment.

Key Responsibilities

• Responsible for cell culture operations in the MSAT lab. This includes, but is not limited to, actual lab operations and any associated lab testing.
• Perform routine monitoring, data collection, analysis, and documentation of process runs, maintaining accurate and compliant lab notebooks and/or electronic records.
• Assist with lab management including but not limited to sample and inventory management, processing incoming RMs and consumables as well as outgoing samples and/or GLP material.
• Support and perform drafting and revising of technical documentation (batch records, SOPs, protocols, recipes, reports, etc.).
• Prepare technical summaries, reports, and presentations to effectively communicate findings to cross-functional teams as needed.
• Ensure compliance with lab safety protocols, GxP requirements, and applicable environmental guidelines.
• Conduct all activities in alignment with company policies, Standard Operating Procedures, and global regulatory guidelines, ensuring adherence to quality assurance standards.
• Remain up to date on all assigned training and ensure completion of any training required for GxP activities prior to executing those activities.

Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biotechnology, or a related scientific discipline.
• 0 to 2 years of relevant engineering or biopharmaceutical industry experience.
• Strong organizational skills with attention to detail and documentation accuracy.
• Excellent written and verbal communication skills.
• Ability to work effectively in a collaborative, fast-paced environment.
• Demonstrated ability to adapt to changing priorities and business needs.
• Must be able to work weekends occasionally.
• Must be able to travel up to 10%.

Preferred Qualifications

• Experience within the biopharmaceutical industry, particularly supporting protein therapeutics.
• Hands-on experience with lab or pilot-scale bioprocessing technologies, including mammalian cell culture and aseptic techniques.
• Experience operating laboratory analytical equipment such as HPLC and other process analytical tools.
• Familiarity with FDA cGMP/GxP regulations applicable to clinical biopharmaceutical manufacturing.
• Experience supporting GxP documentation systems, procedures, and compliance activities.