FUJIFILM Cellular Dynamics, Inc · 1 month ago
Engineer/Scientist 2 Material Science
US-NC-Holly Springs
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Cellular Dynamics, Inc is a company focused on biotechnologies, and they are seeking an Engineer or Scientist 2 in Material Science. This role involves supporting the design of new single-use consumables, assisting in testing programs, and collaborating with manufacturing teams to address material-related issues.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Supports the team with the introduction of new raw materials, and associated document requirements
Assesses vendor change notifications, and provides input on raw materials related matters
Supports change requests for introduction, modification, and discontinuation of raw materials
Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
Supports process sub-teams throughout the phases of technology transfer (TT)
Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
Supports generation of sampling plans for process validation reports (PVRs) and investigations
Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost
Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives
Other duties, as assigned
Qualification
Required
Bachelor's degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; OR
Master's degree in Engineering, Life Science or Chemical Engineering with no relevant experience
Experience working in a Good Manufacturing Practices (GMP) environment
Preferred
Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting
Experience supporting the following: Writing portions of regulatory filings and regulatory audits
New product launches and validation of process
Global or multi-site validation programs
Company
FUJIFILM Cellular Dynamics, Inc
Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.
51-200 employees
H1B Sponsorship
FUJIFILM Cellular Dynamics, Inc 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
2023 (4)
2021 (1)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Blake Anson
Senior Director - Discovery Research Partnering
Ilyas Singec
Chief Scientific Officer
Recent News
Company data provided by crunchbase