Sr. Specialist 2, Global QC Raw Materials (Documentation)

Position Overview

The Sr. Specialist 2, Global QC Raw Materials (Documentation) is responsible for, but not limited to, implementing new raw materials, including specification authoring, requesting LIMS builds, and assessing changes. This role participates in planning and tracking QC readiness for clinical and commercial manufacturing, and ensures all documentation is in accordance with Good Manufacturing Practices (GMP) and that all reported results are accurate. The Sr. Specialist 2, Global QC Raw Materials onboards new materials in line with Fujifilm Diosynth Biotechnologies (FDB) and customer expectations. This role authors events, deviations, and CAPAs related to new materials, specifications, and other tech transfer activities.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

Job Description

What You'll Do

 

• Creates specifications for new raw materials and updates existing specifications in line with the specification justifications or agreements with customers• Provides assessments and QC RM requirements, and executes action items for change controls for the onboarding of materials based on vendor documentation• Coordinates and drives investigations for deviations and CAPA's, as needed

• Assess and executes action items of raw material related CC's/VCN's• Authors, initiates, and assesses change controls to handle internal and external changes to specifications• Plans and tracks QC RM activities to support campaign readiness using smartsheets• Supports existing customers on RM related topics (e.g. documentation requests for regulatory filings)• Participates in raw material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.)• Reviews work related to specifications and testing strategy documents• Partners with LIMS team for the creation of LIMS builds for new materials and updates of existing builds for existing materials• Participates in cross functional, collaborative, and project team assignments• Performs other duties, as assigned

 

Minimum Requirements:

 

• Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years’ experience OR• Master’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years’ experience OR• PhD with 1+ years of applicable industry experience• 4+ years’ experience in a GMP environment

 

Preferred Requirements:

 

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

 

 

Physical and Work Environment Requirements:

 

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 240 minutes.

Ability to sit for prolonged periods of time up to 240 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.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in warm/cold environments (5 C)

Will work in small and/or enclosed spaces.

 

To all agencies: Please, no pho