Scientist 2, QC Analytical Development Tech Transfer Lead

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

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.

Minimum Qualifications

Bachelors 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
Masters 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 Qualifications

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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job the employee is required on a regular basis to:

Work in an environment which may necessitate respiratory protection.
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
Will work in warm/cold environments.

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 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.

*LI-Onsite

EEO Information

Fujifilm is committedto 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 Information

If 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 ().

Required Experience:

Position OverviewThe 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 pro...