Process Engineer

Primary Duties and Responsibilities

• Work closely with internal and external subject matter experts, process chemists, process engineers, and project managers under minimal supervision.
• Provide the technical lead for development and validation of complex advanced manufacturing processes utilizing state-of-the-art technology.
• Work with external subject matter experts and stay abreast of latest technologies and applicable federal regulations.
• Execute development studies to support lab scale and commercial API manufacturing processes.
• Provide technical leadership for transfer of a completely defined process to contract manufacturing organizations for manufacturing under cGMPs.
• Prepare and review relevant documentation including, but not limited to, reports, specifications, and batch records, as well as update relevant lab records.
• Aids in the creation and submission of Drug Master Files (DMFs).

Qualifications

• Bachelor’s degree or higher in Chemical Engineering, Chemistry, or a related field, or equivalent experience.
• A minimum of 5 years overall experience with >3 years of small-molecule API manufacturing/scale-up experience.
• Strong understanding of reaction mechanisms, impurity control, and downstream purification unit operations.
• Solid grasp of cGMP, data integrity, and regulatory expectations; strong technical writing skills.
• Experience with FDA Q7A Good Manufacturing Practice Guidance for APIs.
• Good mechanical aptitude.
• Solid understanding of analytical instrumentation and techniques as well as Process Analytical Technology (PAT).