MSS Manufacturing Supervisor

Position Description

At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences).

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Responsibilities

• High attention to detail to maintain high accuracy in all functions.
• Leads day-to-day EMS Plant operation.
• Ensures all safety processes and requirements are followed and creates a safe work environment.
• Ensures all quality and production processes and requirements are followed.
• Provides training and supervision, of EMS Plant manufacturing staff.
• Collaborates with MSS Planner to implement EMS Plan manufacturing schedule.
• Makes daily work assignments for EMS Plant staff
• Manages and troubleshoots production using Production software (SAP).
• Manages all aspects of EMS Plant inventory including inventory ordering, planning, reconciliation, cycle counts, and down packing.
• Performs and directs non-GMP powder manufacture.
  • Staging
  • Powder Formulation
  • Powder Manufacturing using Impact Mills and IBC Blenders
  • Trace Powder Manufacture using Ball Mills
  • Powder Packaging and Labeling – Finished Goods and Semi-Finished Goods
  • In-process testing of hydrated samples (pH, osmolality, powder density as needed)
• Performs and directs non-GMP liquid manufacture
  • Staging
  • Liquid Formulation – Powder Hydration, Mixing, Step-based ingredient additions
  • Liquid Processing – Aseptic Filling, Packaging, and Labeling
  • In-process testing (pH, osmolality, liquid density as needed)
• Coordinates and Communicates EMS Plant activities with other departments including Commercial Operations and Quality.
• Coordinates shipping of Finished Goods.
• Supports and participates in development and investigative work in the EMS Plant for other departments including R&D, MSE, and Quality.
• Supports and participate in production and analysis of test batches, scale-up batches, and pilot batches in the EMS Plant
• Manages maintenance, validation, and verification of the EMS Plant facility and equipment.
• Makes recommendations for the improvement of any procedures or processes to improve efficiency, cost, safety, and product quality.
• Proposes, writes, and reviews departmental policies and procedures (SOPs/DTIs).

• B.S. in Biology, Chemistry or Chemical Engineering or related field
• 4+ years in an R&D or Manufacturing role
• 3+ years of direct leadership
• Familiar with powder and liquid product manufacture required.
• Experience with aseptic filling processes preferred.
• Familiar with pharmaceutical bioproduction processes preferred.
• Excellent time management, understanding of quality requirements, strong attention to detail, and good communication skills
• Familiar with interactions between various business functions within an organization
• Active, quick learner, and able to prioritize and manage changing business needs
• Experienced using Microsoft Office and ERP software such as SAP
• Familiar with buffers and cell culture media preferred
• Familiar with bench scale laboratory equipment and practices
• Good Math skills, computer skills and a good understanding of general Biology, Chemistry and Biochemistry
• Ability to speak, read, and write in English.
• Good oral and written communication skills.

• For California, the base salary range for this position is $88,452 - $115,293. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

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