Scientist 1, Global QC Raw Materials (Microbiology)

Fujifilm • Holly Springs, NC

244d

About The Position

The Scientist 1, Global QC Raw Materials (Microbiology) liaises with various external collaborators, contract laboratory organizations, QC testing teams and QA groups to ensure training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with the pharmacopoeias and ICH guidelines. This role generates protocols and reports to support tech transfer activities and performs change control assessment activities for tech transfers to include, implementation of new raw materials, new test laboratories, specifications updates e.g. new methods and new vendors.

Requirements

• Bachelor's Master's in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years' experience OR
• Master's in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years' experience OR
• PhD with 1+ years of applicable industry experience
• 4+ years of experience in a federally regulated GMP environment
• Experience with method transfers
• In-depth knowledge of Raw Material methodology as it pertains to cGMP

Nice To Haves

• In-depth knowledge of Raw Material methodology as it pertains to cGMP

Responsibilities

• Supports RM tech transfer activities by implementing methods for Bioburden, Endotoxin and Identification of bacteria species either internally at FDB or at external CLO's
• Performs troubleshooting in close collaboration with FDB or external CLO's to ensure suitable methods can be implemented
• Authors protocols and reports for proving method suitability for internal FDB methods according to compendial requirements
• Reviews and approves external protocols and reports for proving method suitability for CLO methods according to compendial requirements
• Participates in internal and external investigations as SME to ensure compliance with FDB processes for deviations or out of specification's (OOS)
• Author strategy documents and updates relevant SOPs
• Oversees compendial methods and scientific guidelines e.g. ICH, EMA, FDA etc
• Performs other duties, as assigned

What This Job Offers

• Career Level: Entry Level
• Industry: Machinery Manufacturing
• Education Level: Bachelor's degree