Specialist, Manufacturing

Role Summary

The Specialist, Manufacturing is responsible for leading and forwarding biological manufacturing. All functions and roles of the manufacturing process are required to be performed with adherence to cGMP and GDP to ensure successful, quality operations. The role participates in training and leading others as well as in fully supporting the scale up and transfer of new products.

Responsibilities

• Performs manufacturing activities according to cGMP, including batch record execution, product and equipment changeover, troubleshooting manufacturing equipment, issue resolution under limited supervision
• Lead process operations in accordance to dynamic production timeline
• Lead safety protocols and cGMP compliance in manufacturing areas.
• Investigate and resolve problems, identifying root causes, and proposing process improvements through clear communication
• Perform aseptic processing operations.
• Operate manufacturing equipment and their operating systems.
• Operate and may maintain in-process production schedules.
• Develop, author and revise operational and equipment MBRs and SOPs
• Maintain gowning qualification status and as needed participates in annual media simulation fills as required.
• Review manufacturing documentation following good documentation practices
• Perform process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements.
• Collaborate within department, cross-functionally and with supporting areas to meet objectives, cross-train and support other areas.
• Contribute to and help develop process improvement initiatives.
• Ensure that equipment and materials are ready and available for production runs.
• Maintain and sustain personal training profile requirements.
• Facilitates keeping training profiles up to date.
• Support investigations, CAPA and change control procedures.
• Responsible for performing On-The-Job training of manufacturing operators in areas of expertise and supporting training for trainees.
• Prepare daily manufacturing schedules.
• Leads manufacturing operational teams to meet on-time schedule requirements.
• Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor’s degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field required.
• 4+ years of relevant industry or research experience required.
• 2+ years’ Bio-Manufacturing experience required.
• GMP experience required.

Skills

• Strong skills in preparing reports with Microsoft Word, preparing, and updating Excel spreadsheets and presentations.
• Able to effectively author and revise Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs).
• Ability to problem solve using continuous improvement tools to identify problems, determine root causes, subsequent solutions and bring about the solution and improvement.
• Ability to present cross functionally to convey information and findings clearly, professionally, efficiently, and effectively.
• Attention to detail, cleanliness, physical and mental flexibility.
• Good perception to implement what has been learned, following guidelines precisely.
• Understanding and application of safety and quality requirements.
• Knowledge of cGMP and good documentation processes.
• Ability to successfully work in a team environment with good communication skills.
• Hands on approach to learned skills.
• Team player with good communication skills.
• Ability to read, understand and apply Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs).

Education

• Bachelor’s degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field required.

Additional Requirements

• This position works onsite across ImmunityBio sites in Southern California.
• This position works in a lab environment.
• Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).
• Ability to work weekends occasionally to support the dynamic production schedule and relevant timelines.
• Ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate cleanroom gowning material and appropriate personal protective equipment is required.
• Travel between multiple manufacturing locations as needed.