Sr Scientist Chemistry focus -QCAT

The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the teambased 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 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.

The work we do at FUJIFILM Diosynth Biotechnologies 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 missiondriven 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 FUJIFILM Diosynth Biotechnologies 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.

Essential Functions:

• Desirable candidate will have a strong QC mindset and bringing QualitybyDesign 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 ontime completion of activities)
• Technical expertise in several of the following fields with focus on Chemistry specifically in the analysis of proteins: H/UPLC (Empower) electrophoresis reduced/nonreduced CE spectroscopy SoloVPE platebased assays (SoftMax Pro) Molecular assays (qPCR ddPCR) SoloVPE. Additionally desirable to have expertise in 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. Latestage 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 multitasking in a fastpaced environment with defined deliverables and deadlines.

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 handeye 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 Chemistry Biochemistry Chemical Engineering Biotechnology/Biopharmaceutical or related field and at least 1 year of experience working in the Biotechnology/Biopharmaceutical industry.

OR

• Master of Science in the Chemistry Biochemistry Chemical Engineering Biotechnology/ Biopharmaceutical industry or related field and at least 6 years of experience working in the Biotechnology/Biopharmaceutical industry.

OR

• Bachelor of Science in the Chemistry Biochemistry Biotechnology/Biopharmaceutical industry or related field and at least 8 years of experience working in the Biotechnology/Biopharmaceutical industry.

OR

• Associate of Science in the Biotechnology/Biopharmaceutical industry or related field and at least 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)

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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.