The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc.  has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDBU and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDBU calls Genki. 

The Manufacturing Specialist is recognized as subject matter expert with regard to cell culture and/or microbial upstream and/or recovery and/or downstream manufacturing operations. Ensures delivery of production execution schedule and adherence to a daily and weekly schedule. Represents Manufacturing at meetings and tours of the manufacturing facility. Initiates and oversees the implementation of operational processes, new technology, and modifications to existing technology or operational processes aimed at cost reduction, efficiency improvements, minimization of downtime, and quality/safety enhancement. Must be able to identify and communicate improvement opportunities and results. Provides feedback regarding operational and manufacturing process performance.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Assists in readiness by compiling processing checklists and standard work into binders at the 2-week readiness window for each batch on the Manufacturing schedule.
• Reviews and updates standard work, as needed.
• Creates, reviews, and updates processing checklists, as needed.
• Coordinates equipment calibrations and maintenance
• Supports equipment/instrument qualifications and documentation with MTS and Validation groups.
• Assists in equipment and supplies ordering, as needed.
• Primary POC for all Cleaning Validation activities. Works directly with MTS CV personnel to confirm sampling requirements. Informs manufacturing staff of CV requirements and expectations, plans and coordinates all CV sampling efforts with MTS, ensures CV samples are taken and CV documentation is completed RFT.
• Performs and owns deviations, CAPA, and CCs, as needed, in support of Cell Culture/ Microbial Manufacturing activities and improvements.
• Communicates with manufacturing. staff directly, with the use of Tier 1 board and Shift Plan
• Participates in department and site-level OpEx projects.
• Interaction with groups such as Materials Management, EHS, Maintenance, Metrology, MTS, Quality Control and Quality Assurance (QA)
• Assists in performing Equipment and Room Coordinator tasks, as needed.
• Hosts manufacturing Tours for clients, audits, and corporate visitors
• Represents Manufacturing at technical, planning & scheduling meetings.
• Troubleshooting quality defects and making any process changes necessary to eliminate the defects, recording corrective and preventative actions.
• Manages Tier 1 and Tier 2 boards.
• Delegate for meetings to represent manufacturing when management is unavailable, including PAs and or PPAs
• Ensure and/or Coordinate pick lists and intermediate thaw requests with supply chain and warehouse.
• Supports interviews of candidates for technician positions, as needed.
• Author, review, and/or revise SOPs, WIs, STD lists, etc. as needed.
• Manages Manufacturing chromatography resin inventory. Coordinates with SSC for upcoming batches/campaigns to forecast and plan resin needs. Plans to utilize Mfg. resin inventory first, before requesting resins from SSC; as applicable
• Reconciles quantity of chromatography resin requested vs. used by Mfg. for newly packed columns. Ensures unused, unopened resins get returned to SDSC / Warehouse and are not retained in Mfg. inventory. Ensures that opened, but unused resins get added to Mfg. resin inventory; as applicable.
• Completes column packing forms for use in packing columns for upcoming batches/campaigns; as applicable.
• Manages upstream manufacturing Direct Issue requests and Media inventories as they pertain to manufacturing operations; as applicable.
• Additional levels of gowning are required in this role on a daily basis.
• All other assigned duties as deemed necessary.

BACKGROUND REQUIREMENTS:

• BS/BA (science preferred) and 3+ years of experience in a cGMP (pharmaceutical/manufacturing environment or AA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing) environment
• Strong computer skills with proficiency in using Microsoft Office Suite (MS Word, Excel, PowerPoint, etc.) for data gathering, data entry, and reporting.

 Desired Skills:

• Experience writing deviations and performing investigations.
• Experience in project management.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

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.