Overview 

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are 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 FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Summary: 

The Staging Coordinator will support the FDBT Manufacturing Team by performing tasks associated with receiving picks, inventory management and/or distribution of BOM, non-BOM, gowning and cleaning materials delivered to the manufacturing staging area. The role is responsible for adherence to current Good Manufacturing Practices (cGMP's), operating Powered Industrial Vehicles (PIV’s), safe handling of chemicals and weighted material, use of validated computer systems, ability to accurately complete documentation, make calculations, and perform physical tasks associated with large scale pharmaceutical manufacturing. The role may be cross trained to support other areas including weighing of raw materials, picking material at the Warehouse and/or issuing material.

Essential Functions:

• Perform all work in a safe and compliant manner. Consistently follow Standard Operating Procedures (SOP's) and departmental policies.

• Staging dispensed raw material for transport and delivery.
• Coordinate with Warehouse the BOM material and supplies delivery to the staging area for USP, DSP and SP.
• Receive material delivered to the staging area and verify BOM or pick lists associated with the Records to assure the correct material and quantity was delivered while ensuring the material is assigned to the correct project. 
• Allocate the material delivered in the designated physical location and SAP bin.
• Conduct inventory counts of materials in the staging area and assure that SAP location reflects physical location.  
• Return material to the Warehouse.
• Discard any expired components allocated in the staging area.
• Identify and report operational issues and process improvement opportunities.
• Communication liaison between Manufacturing and Warehouse personnel for staged materials needs.
• Stage prepared medias and buffers allocated in the exterior storage area for USP and DSP processing.

• Maintain a positive, professional, and customer-oriented attitude.
• Maintain satging area in a constant state of compliance.
• Maintain an effective working relationship with others.
• Maintain the confidentiality of proprietary company information.
• Perform all other duties as assigned.

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Proficient with Microsoft Office applications.
• Strong knowledge in SAP. 
• Experience in a GMP environment.
• Strong knowledge in Good Documentation Practices (GDP).
• Good self-discipline and attention to detail.
• Excellent on multi-task and prioritize work assignments with minimum supervision. 
• Strong organizational skills with the ability to coordinate multiple activities.

• Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.  Must be able to work alternative shift hours and weekends as required.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, bending, stooping, pushing, pulling, reaching above shoulders, and stretching.
• Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Hand-eye coordination and manual dexterity sufficient to operate Powered Industrial Vehicles
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.  
• Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally and push/pull heavy loads using material handling equipment.
• On-site attendance is mandatory.

Minimum Qualifications:

• Associate degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 1 year of relevant experience; OR
• High School/GED with 2 years relevant experience
• Experience in GMP environment

Preferred Qualifications:

• Biotechnology Certificate
• Experience operating Powered Industrial Vehicles

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.