Position Overview

Summary: The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

 

The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. 

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Summary: The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

 

The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.

 

Reports to                Associate Director, QC Analytical

Work Location         College Station, TX 

 

Essential Functions:

• Desirable candidate will have a strong QC mindset and bringing Quality-by-Design concept (QbD) into analytical activities to ensure robust methods entering the QC space.
• Project management expertise for analytical activities (planning, timeline creation, team management, effective escalation, drive for success and on-time completion of activities).
• Technical expertise in several of the following fields, specifically in the analysis of proteins: plate-based assays (SoftMax Pro), Molecular Biology assays (qPCR, ddPCR), Cell based assays (e.g. Potency, Cytotoxicity, TCID50, BacPAK), H/UPLC (Empower), electrophoresis, spectroscopy, microbiology (bioburden, endotoxin), and Compendials including appearance, pH, osmolality. As a senior scientist, you must have demonstrated problem solving capabilities for standard biopharmaceutical laboratory techniques.
• Designing, managing, and executing protocols for the Qualification, Validation, Verification or assay Tech Transfer of recombinant biopharmaceutical protein analytical methods. Late-stage method validation experience is also highly desired.
• Managing a team of scientists in a direct or matrix environment with an eye towards team development with high performing scientists.
• Regulated GMP experience, with knowledge of ICH guidelines for methods, positive working relationships with Quality groups and experience with opening, executing and closing protocol events, investigations and change controls within Trackwise. Regulatory audit experience is a plus.

Required Skills and Abilities:

• Must have the cell culture experience and bioassay design experience.
• Strong mentorship skills.
• Excellent work ethic with a strong emphasis on data integrity.
• Strong oral and written communication skills.
• Demonstrated ability to engage with clients.
• The optimal candidate will have a keen eye for detail, excellent writing skills, and desire to engage in a positive manner with clients.
• Continuous improvement initiatives (initiating and completing).
• Excellent interpersonal skills, the ability to work individually or as part of a team; a person who highly values collaboration.
• Comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines.
• Role model for company core values of trust, delighting our customers, and Gemba.

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, some bending, stooping, and stretching.
• Use 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, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position.
• Lift up to 30 pounds on occasion.
• Attendance is mandatory.

Qualifications:

• PhD in the Biotechnology/Biopharmaceutical industry, or related field, and 1+ year of experience working in the Biotechnology/Biopharmaceutical industry; OR,
• Master of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 6+ years of experience working in the Biotechnology/Biopharmaceutical industry; OR,
• Bachelor of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 8+ years of experience working in the Biotechnology/Biopharmaceutical industry; OR,
• Associate of Science in the Biotechnology/Biopharmaceutical industry, or related field, and 10+ years of experience working in the Biotechnology/Biopharmaceutical industry.

Preferred Qualifications:

• Experience working in or interfacing with a regulated GMP environment is desirable.
• Experience working in a contract manufacturing or testing organization is preferred (demonstrated ability to work with clients).

EEO Information

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.

ADA Information

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 (FDBTHR@fujifilm.com or (979) 431-3500).