Senior Specialist, Engineering

Serve as a leader in the Formulation, Laboratory, and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility. Contribute to equipment and facility design, system commissioning/ qualification, regulatory certification, as well as other workstreams’ critical activities to enable facility startup and operational readiness. Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of the company’s pipeline. Support the formulation, process development, and scale-up activities, quality investigations and change management, and author GMP standard operating procedures and protocols in support of facility operations. Education Minimum Requirement: Master’s degree in Chemical Engineering, Chemistry, Industrial Engineering, Pharmaceutical Sciences or closely related scientific field with 2 years relevant experience OR a Bachelor’s degree in Chemical Engineering, Chemistry, Industrial Engineering, Pharmaceutical Sciences or closely related scientific field with a minimum of 5 years relevant experience. Required Experience and Skills: Experience in leading and supporting quality investigations and change management and experience with quality systems also required. Must have knowledge and experience of drug product aseptic processing, equipment, and sterile technique; and familiarity with United States and European Union Good Manufacturing Practice (GMP) and Safety compliance regulations. Must possess ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture. Must possess the ability to prepare Standard Operating Procedures (SOP) and other documents in accordance with current good practice guidelines and regulations (GxP). Must have effective interpersonal and communication skills, both verbal and written; and excellent organizational skills. Must demonstrate a desire and willingness to learn, contribute and lead; and a track-record of independent problem-solving.