Scientist 2, QC Analytical Development - Tech Transfer Lead

Fujifilm•Holly Springs, NC

3d•Onsite

About The Position

Position Overview The Scientist 2, Analytical Development (AD) Tech Transfer (TT) manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, transfer summary reports and specification justification reports, as needed. This role effectively communicates and operates between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do Supports analytical method TT and execution including method verification, transfer and validation.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.