The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance.  This role contributes to the successful delivery of released product in support of clinical trials and commercial production.

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Manufacturing Senior Associate

Department:  Internal Manufacturing

Location:  Thousand Oaks, CA

Reports To:  Manufacturing Supervisor

SUMMARY OF POSITION:

The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance.  This role contributes to the successful delivery of released product in support of clinical trials and commercial production.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operation
• Support production in a controlled environment and train staff as needed
• Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols
• Under minimum supervision, assist in all areas of cell processing and all related duties as required including (stocking, inventory management, material movement and reconciliation, controlled forms management, planner entry form issuance and other tasks)
• Independently support manufacturing batch record review
• Assists in the development of manufacturing electronic batch records
• Author drafts and revision of standard operating procedures, /work instructions/batch records  of existing and new processes and or equipment as needed
• Support routine maintenance and cleaning of rooms and equipment
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
• Initiate Work orders as needed
• Independently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA records
• Support as SME training of staff as applicable
• Identifies and implements continuous improvements
• Support NPI and Process Transfer activities as needed
• Execute visual inspection of final drug product.
• Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed).
• Assist the team with maintaining an up-to-date working inventory for the equipment/supplies 
• Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentation
• Participate in a detailed training program and develop training plan 
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements 

BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):

QUALIFICATIONS:

• Bachelor of Science (B.Sc.) with 2 + years of applicable biopharma experience; or
• Associate degree with 4+ years of applicable biopharma experience; or
• High school diploma with 7+ years of applicable biopharma experience

PREFERRED QUALIFICATIONS:

• Ability to follow verbal and written instructions
• Problem solving skills
• Detail oriented
• Team player
• Ability to work with minimal supervision
• Strong communication skills
• Understanding of Aseptic Behaviors / Techniques
• Experience in biomanufacturing environments

WORK ENVIRONMENT:

• Work is generally performed in a Good Manufacturing Practice (GMP) facility.  A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:
  • Makeup, painted nails
  • Hair products (spray, gel, wax)
  • Perfume and cologne
  • Jewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear
  • piercings, etc.)
• Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment
• Personal Protective Equipment is required to perform certain tasks (i.e., latex/nitrile gloves, respirators and or masks, goggles, plant dedicated scrubs/shoes, full body gown that covers all exposed skin)
• Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPE
• Required to handle biohazardous and hazardous material via direction of Standard Operating Procedures

PHYSICAL REQUIREMENTS:

• Medium work that includes moving, lifting, pushing and or pulling objects up to 50 pounds.
• Medium work that includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels.
• Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
• Position requires a combination of standing in the manufacturing environment and walking around the facility.
• Open to work various shifts as needed
• Required to work weekends and holidays

SALARY AND BENEFITS:

• $38.25 to $42.75 per hour, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

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.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).