Manufacturing Technical Specialist

Job Description

Job Summary

The Manufacturing Technical Specialist position is the equivalent to and is a part of the engineering job family. This role would be equivalent to an Senior Engineer in our Manufacturing Sciences and Technology organization.

The Manufacturing Technical Specialist is an integral member of the OSUT (Oceanside Single Use Technology) team in Oceanside. The OSUT is designed to be a state-of-the-art large molecule drug substance facility which supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, utilize single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. The team members will work closely with the existing staff in the stainless steel operations as well as with South San Francisco Clinical Supply Center (CSC).

In this role the qualified individual will be part of the Operations, Process Support and Process Engineering team that starts up the facility. There will be one team that will support the entire process from initial cell bank thaw through bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with the project team on equipment or consumable design. The candidate will engage with customer groups, network teams and project teams to seek opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions.

Duration and Potential Extension :

The role requires 100% time commitment at site Oceanside through the end of 2024, with potential extension based on the development and achievement of deliverables.

The high-level work outcomes are :

• Process equipment installed per design.
• Start-up, Commissioning, and Qualification activities completed on schedule.
• OSUT Manufacturing Core is fully qualified up to OQ and can be released for GMP use.

Deliverables and Milestones

Primary Responsibilities :

Qualifications :

Target Experience & Knowledge :

Prefer experience, knowledge working with Single Use Technologies or modular operations

Skills & Competencies :

Work Environment / Physical Demands / Safety Considerations

EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

Meet Your Recruiter

Kevin Nair

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