The Scientist 1, QC Analytical Development Chemistry supportsthe transfer of analytical Chemistry 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 Scientist 1, QCAD ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, authors transfer documents and executestesting as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods.
Company OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.
Job Description
What You'll Do
• Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation.
• Interfaces with customers and program management to identify analytical needs and method gaps during project scoping
• Participates in meetings for TT programs with cross-functional teams and key stakeholders
• Authors technical documents including transfer and validation protocols / reports
• Communicates with QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines
• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements
• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.)
• Supports regulatory requests and inspections
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques
• Supports best practices for TT and PPQ strategies globally, as required
• Performs other duties, as assigned
Minimum Requirements:
• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO) OR
• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 4+ years of experience, OR
• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 2+ years of experience
• Experience with analytical method transfers
• Experience with project management and demonstrated ability for providing regular updates and escalations
• Proficient in physical and chemical testing methods for biological products, including HPLC/UPLC chromatography (Protein A/G titer,
SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric
focusing (icIEF)); general pharmaceutical properties methods.
• 1-3 years of experience in a GMP environment
• Relevant experience in analytical method development, transfer, and validation
Preferred Requirements:
• Experience with Customer Relationship Management
• Prior drug substance experience, including analytical method validation, transfer, commercialization, and manufacturing support
and troubleshooting
Physical and Work Environment Requirements:
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 60 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.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.
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.
EEO InformationFujifilm 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 InformationIf 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 (FDBN_PNC@fujifilm.com).
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