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
- Successful Automation SAT completion
- Completion of Operation Verification
- Successful Water Run for Process Equipment completion
- Successful Technical Run for Process Equipment completion
Primary Responsibilities:
- Reviews & approves validation documents and protocols
- Participates in safety assessments/reviews
- Ensures necessary operating procedures are in place prior to C&Q execution on the assigned unit operation(s)
- Ensures training materials and curriculum are developed and revised as needed
- Performs/updates risk assessments in partnership with network and Quality counterparts
- Coordinates and conducts start-up and troubleshooting activities.
- Execute equipment C&Q, write-up, and review using existing documentation and protocols.
- Collaborate with the Automation engineering team to coordinate control systems design, installation, and commissioning needed for the core processing systems.
Qualifications:
Target Experience & Knowledge:
- 15 or more years work experience in the pharmaceutical or related industry
- 10 or more years direct or indirect people and team management experience
- 5 or more years work experience in a cGMP regulated environment, preferably in biologics manufacturing
Prefer experience, knowledge working with Single Use Technologies or modular operations
Skills & Competencies:
- Excellent verbal and written communication skills
- Excellent business acumen
- Ability to influence at all levels of an organization
- Builds trustful and effective relationships
- Thinks strategically and translates strategies into actionable plans
- Takes responsibility, drives results, and achieves expected outcomes
- Comfortable working in an agile and ambiguous environment
- Has demonstrated a commitment to quality
* Bachelor's Degree required (science or engineering is preferred)
* Professional, Graduate, or higher-level degree is preferred
Work Environment/Physical Demands/Safety Considerations
- Work in office, manufacturing, and, to a lesser extent, laboratory environment.
- May be on feet for 4 to 5 hours a day.
- Able to work a flexible schedule to meet start-up activity requirements.
- Lifting up to 25lbs may be required.
- May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
- May work with hazardous materials and chemicals.
- Most of the time will work a standard Monday - Friday 8am - 5pm type of schedule
- There will be times where we need to work a shifted 12/12/12/4 Schedule during the technical run. Expected to last about 6 weeks. Sometime in August/September timeframe
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.
