Job Details

Senior Scientist

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:

• 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 (...@fujifilm.com or (979) ###-####).