MSS Manufacturing Supervisor - FISI - FUJIFILM Irvine Scientific

We are hiring a MSS Manufacturing Supervisor. MSS Manufacturing Supervisor is responsible for all departmental production activities for manufacture of non-GMP products in the EMS Plant.  Acts as working supervisor performing manufacturing tasks as well as providing leadership to the manufacturing team.

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.

External US

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 review departmental policies and procedures (SOPs/DTIs).

Required Skills/Education

• 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.
• 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.

Salary and Benefits:

• For California, the base salary range for this position is $65,740.00 - 85,284.00. 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

EEO/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

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