The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow's medicines - our Genki - will always be our driving force.  While working as a Manufacturing Associate with our Thousand Oaks team, you'll be joining other motivated individuals who fuel one another's passions and embrace every day as an opportunity.  We am to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values.  We pursue our fullest potential as individual contributors and team members.  We strive to be the employer of choice and offer a competitive compensation and benefit package.

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. 

Position Summary: The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

Reports to: Manufacturing Supervisor

Function: Technical Operations (Manufacturing)

Location: Thousand Oaks, CA

SUMMARY OF POSITION:

The Manufacturing 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 environment
• Support production in an aseptic environment.
• Executes on production batch records and work orders according to SOPs and protocols.
• Generates work orders.
• Assist in all areas of cell therapy and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects).
• Assists in manufacturing batch record review.
• With supervision, initiates deviations and participates in root cause investigations and CAPA.
• Drafts and revises SOPs/ WINs/ BRs.
• Execute SAP transactions.
• Execute media batching.
• Routine maintenance and cleaning of rooms and equipment.
• Identifies and implements continuous improvements.
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP     requirements.
• Adhere to all safety protocols and procedures.
• 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 
• Maintain inventory of equipment and supplies 
• Identifies and implements continuous improvements 
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements 
• Adhere to all safety protocols and procedures 

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

Qualifications

• Bachelor of Science (B.Sc.) with 0-3 years of applicable biopharma experience; or
• Associate degree with 2+ years of applicable biopharma experience; or
• High school diploma with 3+ 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:

• $29.50 to $33.50 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).