FUJIFILM Holdings America Corporation · 3 months ago
Sr. Analyst 1, QC Analytical Development Bioassay
US-NC-Holly Springs
Full-time
Onsite
Mid, Senior Level
2+ years expFUJIFILM Holdings America Corporation is a leader in the biotechnology sector, and they are seeking a Sr. Analyst 1 for their QC Analytical Development Bioassay team. This role involves supporting the implementation of analytical methods, ensuring GMP compliance, and collaborating with cross-functional teams to facilitate method transfers and validations.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Executes analytical method transfers and validations for plate and cell-based Bioassays for the QC Analytical Development team
Ensures compliance of analytical testing with appropriate GMP regulations
Participates in regular meetings for TT programs with cross-functional teams and key stakeholders
Authors and reviews SOPs, protocols, and technical reports
Works cross-functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure transfer of methods 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, as needed
Supports best practices for TT and PPQ strategies globally, as required
Coordinates and supports QCAD Bioassay lab activities and provide training for QC Bioassay lab technicians
Performs other duties, as assigned
Qualification
Required
B.S. in Microbiology, Virology, Biology, Biological Sciences, Engineering, or related science field with 2+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
M.S. in Virology, Microbiology, Biology, or related science field with Microbiology, Virology, Biology, Biological Sciences, Engineering, or related science field with 0+ years of previous experience
1+ years' experience in a GMP environment
Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA, Dot Blot, etc.)
Experience with analytical method development, tech transfers and validation residual testing for DNA, Host Cell Protein (HCP), Protein A
Preferred
Master's in Virology, Microbiology, Biology or related science field with 1+ years of related experience
Experience with LIMS software
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase