Senior Process Development Engineer

Senior Process Development Engineer

Job Overview

We are seeking a detail-oriented and proactive Senior Process Development Engineer to join our team. This role focuses on the translation of new laboratory-scale chemical processes into safe, executable manufacturing instructions for scale-up within a small molecule API production facility. The ideal candidate will be flexible to adapt across kilo lab, plant, and HPAPI production areas and provide guidance to other team members.

Key Responsibilities

New Process Scale-Up & Execution

• Process Translation & Instructions: Interact closely with chemists to understand new chemical processes, translate them into executable instructions (batch records), and guide operators through initial production.
• Kilo lab or Plant Scaling: Learn and scale up production processes from the laboratory to the kilo lab or plant infrastructure, troubleshooting and adapting techniques when small molecule processes do not scale as expected. Assist other engineers with addressing challenging scale up situations.
• HPAPI Production: Be able to support HPAPI production processes and be the site’s subject matter expert.
• Operational Supervision: Oversee the execution of processing, participate on the production floor as appropriate, and review executed batch records to ensure technical compliance.

Documentation & Safety Compliance

• Supporting Documentation: Author, review, and organize necessary processing documentation, including batch records, deviations, material specifications, hazard sheets, air emissions data, and processing reports.
• Safety & Risk Mitigation: Conduct process safety meetings, develop safety review packages, and ensure all scaling activities strictly adhere to plant safety protocols.
• Cross-Functional Collaboration: Interact closely with Chemistry, Quality, and Operations departments throughout the production lifecycle, while managing external interactions with vendors and contractors.

Technical Troubleshooting & Client Interaction

• Process Troubleshooting: Apply development troubleshooting and problem-solving skills to identify, investigate, and resolve process deviations or scaling anomalies directly on the shop floor.
• Client Status Updates: Act as a key technical point of contact for clients, hosting regular project status updates, delivering tech transfer summaries, and communicating technical milestone progressions clearly.
• Infrastructure Support: Provide day-to-day chemical engineering support for the maintenance, optimization, and upkeep of pilot plant equipment and infrastructure.

Required Skills & Qualifications

• Education: B.S. or M.S in Chemical Engineering or Chemistry
• Experience: Ten or more years of experience in scale-up/preparation of pharmaceutical and specialty chemicals
• Technical Competencies: Strong foundational knowledge of chemical process scale-up, mass/energy balances, process safety management, and technical document authoring.
• Collaborative Nature: Exhibits effective time management and a strong multi-tasking mindset to self-manage assigned tasks, drive projects to completion, and work effectively in a multi-disciplinary team environment.