Shire Jobs

Overview

The work we do at FDB has never been more importantand 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 peoples 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.

External US

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.

The QC Analyst, Cell Biology II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

Reports to QC Supervisor/Manager, Cell Biology

Work Location College Station, TX

Primary Responsibilities:

• Participate in training the QC Bioassay Staff at FDBT in the established release methods.
• Perform QC analytical testing for GMP release and stability testing as needed.
• Perform ELISA based methods, cell-based assays and qualification of critical reagents methodologies.
• Execute tech transfer, qualification, and validation protocols as needed.
• Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
• Support the establishment of a system for managing test samples, reagents and reference standards.
• Report excursion/out-of-specification results to QC Departmental management.
• Assist in the preparation of technical proposals, amendments, reports and memoranda.
• Provides OOS investigational support as needed.
• Perform other duties as assigned.

Qualifications:

• Bachelors degree preferably in Biology or Biochemistry with 2+ years of relevant laboratory experience; OR
• Associates degree preferably in Biology or Biochemistry with 3+ years of relevant laboratory experience.
• AND 1+ year of experience in a GLP/GxP or a comparable federally regulated environment required.
• Familiar with monoclonal antibody testing methodology.
• Experience in assay troubleshooting and problem solving.
• Familiar with Quality Systems.
• Proficient in ELISA based methods, cell-based assays and qualification of critical reagents methodologies.
• Ability to analyze raw data, assess assay and system suitability criteria.
• Perform as a SME in the designated methods transferred into FDBT from FDBU.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Excellent attention to detail.
• Computer proficiency required.
• Excellent written and oral communication skills.
• Excellent organization and analytical skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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, some bending, stooping, and stretching.
• se hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• 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, and gloves.
• Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
• Attendance is mandatory.

Join us! FDB is advancing tomorrows 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.

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 email FDBTHR@fujifilm.com or call 979-431-3500.