Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

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 manufacture 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 we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About the Role

The QC Analytical Development (AD) Chemistry Scientist 2 is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

What You'll Do

• In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria.
• Relevant experience in analytical method development and validation.
• Demonstrated application and knowledge of ICH guidelines on analytical method validation.
• Experience with customers and analytical method transfers.
• Experience with project management and demonstrated ability to monitor project progress and provide status updates.
• Demonstrated communication skills, technical proficiency, scientific creativity, collaboration with others and independent thought.
• Planning of projects in terms of timing, execution of deliverables and resource allocation.
• Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities.
• Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and SmartSheet.
• Familiarity with LIMS Software.
• Proficient in physical and chemical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry sub-visible particle analysis, and glycan analysis, and peptide mapping.
• Displays an advanced knowledge of GMP requirements for laboratory operations.
• Possesses a broad knowledge of quality control operations, systems, and directives.

Minimum Requirements:

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
• 4-6 years experience in a GMP environment

Preferred Requirements:

• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience, OR
• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience
• Experience with Customer Relationship Management
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Abiltiy to stand for prolonged periods of time up to 120 minutes

Abiltiy to sitfor prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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 via-email, 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.