Scientist 2, QC Analytical Development Chemistry

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Scientist 2 QC Analytical Development Chemistry is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The Scientist 2 QC Analytical Development Chemistry ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients including the following analytical methods: chromatography (GC HPLC UPLC SEC) spectroscopy (MS GC/MS LC-MS/MS UV UV-Vis FTIR) electrophoresis (GE non-reducing and reducing CE-SDS imaged capillary isoelectric focusing (icIEF)) wet chemistry glycan analysis sub-visible particle analysis peptide mapping and physical appearance etc.

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

Leads analytical chemistry method tech transfer and execution including method verification transfer and validation
Interfaces with customers and program management to identify analytical needs and performs risk and gap assessments during project scoping
Participates in regular meetings for TT programs with cross-functional teams and key stakeholders
Serves as the subject matter expert (SME) to author and review SOPs transfer plans protocols and 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
Supports best practices for TT and PPQ strategies globally as required
Performs other duties as assigned

Minimum Requirements:

B.S. 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
M.S. 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

Preferred Requirements:

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

Physical and Work Environment Requirements:

Will work in 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 (5 C)

Will work in small and/or enclosed spaces.

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.

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 QC Analytical Development Chemistry is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The Scien...