This role is based in our Manufacturing Science and Technology (MSAT) department within the Oceanside Process Sciences team, where we provide critical technical and scientific support to large-scale, automated biopharmaceutical manufacturing. As an Engineer/Scientist, you will drive continuous innovation and support process validation through pilot and small-scale studies. Join our collaborative, high-functioning team to help deliver life-changing therapies to patients globally.

The Opportunity:

• Contributeto daily operations in our small-scale, pilot plant, and analytical laboratory, including coordinating tasks such as setting up, inoculating, maintaining, harvesting, and cleaning bioreactor equipment.

• Leadtechnical transfers of Phase III molecules from late-stage process development to commercial launch scale, managing scale-down model verifications and facility fit studies.

• Executeand oversee pilot and small-scale studies to support process validation, optimization, and characterization efforts.

• Performdetailed analysis of in-process intermediates and raw materials to support site investigations, process development, and routine testing.

• Leadtechnical teams in support of site investigations, commercial product release activities, and the remediation of discrepant manufacturing incidents.

• Collaborateclosely between late-stage process development groups and commercial manufacturing sites to ensure transparent communication and knowledge sharing.

• Supportthe setup, commissioning, factory acceptance testing, and site acceptance testing of new pilot plant and laboratory equipment.

Who you are:

• You hold a Bachelor's, Master's, or Ph.D. degree in Chemical/Biochemical Engineering, Life Sciences, or a relevant scientific discipline.

• You bring 4–6 years of hands-on experience within a biopharmaceutical manufacturing, engineering, or relevant scientific field.

• You possess a demonstrated working knowledge of core regulatory requirements, process controls, and manufacturing execution systems.

• You demonstrate strong technical leadership, strategic thinking, and the ability to work independently under limited supervision to take projects from idea inception to implementation.

• You are an excellent communicator and collaborator, with proven interpersonal and organizational skills to interface effectively across multi-disciplinary teams and external vendors.

Preferred:

• You have a high level of demonstrated initiative, a flexible work approach, and the ability to multitask effectively to meet changing run schedules.

• You possess strong operational troubleshooting and creative problem-solving skills to resolve complex equipment and process issues.

• You are comfortable working in a dynamic environment, which includes standing for 4 to 5 hours a day, lifting up to 40 lbs, and operating within a cleanroom environment requiring standard gowning protocols.

Relocation benefits are not available for this job posting.