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FUJIFILM Cellular Dynamics, Inc · 3 days ago

Scientist 2, QC Analytical Development - Tech Transfer Lead

US-NC-Holly Springs

Full-time

Onsite

Senior Level

6+ years exp

FUJIFILM Cellular Dynamics, Inc is building the future of bioproduction in Holly Springs, North Carolina. The Scientist 2, Analytical Development Tech Transfer Lead manages the transfer of QC analytical methods for drug substances and products from customers into large-scale manufacturing, ensuring compliance and optimizing processes.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Supports analytical method TT and execution including method verification, transfer and validation

Works with customers and the TT program to lead and manage the QC AD TT process

Interfaces with customers and program management to identify analytical needs and performs risk and gap assessments during project scoping

Develops project plans that align with program scope and customer expectations

Ensures the analytical team understands business goals and customer expectations and delivers results according to project deadlines

Participates in regular meetings for TT programs with cross-functional teams and key stakeholders

Serves as the subject matter expert (SME) to review, author and deliver SOPs, transfer plans, protocols, reports, and transfer summary reports

Liaises with Contract Laboratory Organizations (CLOs), 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 QC AD team to investigate any project challenges with necessary risk assessment tools and techniques

Support best practices for TT and PPQ strategies globally, as required

Performs other duties, as assigned

Qualification

Analytical method transferGMP environment experienceProject managementQuality systems experienceRoot cause analysisCustomer relationship managementRisk management toolsCommunication skills

Required

Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 8+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO); OR

Master's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of experience; OR

Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 4+ years of experience

4+ years of experience working in a regulated GMP environment

Experience managing projects, programs, or portfolios related to analytical laboratories, research & development, Biotech, CRO, CLO, or Pharma industry

Preferred

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)

Experience with root cause analysis (RCA) and risk management tools

Company

FUJIFILM Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

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

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Trends of Total Sponsorships

2023 (4)

2021 (1)

2020 (3)