Scientist I, QC Raw Materials Tech Transfer

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Job description

Overview:
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.

External US:
About This Role

The QC Raw Materials (RM) Scientist 1 will be responsible for participating in the Technology Transfer of raw material methods into FDBN Quality Control Laboratory, with limited supervision. This includes onboarding of new and generic raw materials as part of new customers/programs. Providing assessments, QC raw materials requirements and executing action items for change controls for the onboarding of these materials based on vendor documentation. Identifying materials together with customers in a cross functional team. Planning and tracking QC readiness for clinical and commercial manufacturing. Provide technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Performs QC RM review of Specification Justification Reports (SJR). Provide technical support for troubleshooting of investigations related to testing of new materials. Authoring specifications according to the SJR's and requesting creation of LIMS builds for the new material. All documentation is in accordance with GMP and ensure all reported results are accurate. Following Tech-Transfer Activities, the position will be responsible for performing release testing using the established analytical methods.

Coordinates and is responsible for raw material release for Raw Materials team.

Prepares monthly metrics for raw material release, as needed.

Performs sampling/release and chemical analysis of materials, as needed.

Represents QC Raw Materials on internal and external tech transfer meetings related to new products.

Performs raw material assessments, identifies requirements and executes actions as part of change control process.

Implements new raw materials, including specification authoring, requesting LIMS builds, assessing changes etc.

Initiating, executing and approval of Trackwise deviations, CAPA's, lab exceptions and invalid assays

Assesses and action item execution of raw material related change controls and vendor change notifications

Ensures QC Raw Material team is on track for internal verification/testing and timelines align with tech transfer project timelines

Coordinates QC Raw Materials and Drug Product activities i.e., transfer plans, validation/verification/transfer protocols and reports, justification specification reports and transfer summary reports, and change control assessments

Creates meeting agenda and minutes, host and facilitates meetings and manages the raw material and drug product method portfolio and provide progress updates to stakeholders.

Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results

Enforces established policies and procedures and identify areas where enhancements will improve daily work

Leads and coordinates implementation of new technologies

Uses in-depth technical knowledge of Chemistry to author and review procedures, protocols and reports where necessary

Supports raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.)

Ensures compliance with cGMP and participate in audits and inspections

Maintains adequate inventory of supplies needed for all raw material sampling including but not limited to pipettes, containers, and consumables.

Ensures good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner.

Reports excursion/out of specifications (OOS) results to the Manager, QC Raw Materials

Provides OOS investigational support as needed.

Performs other duties, as assigned

Minimum Requirements

B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline

BA/BS: 6+ years' experience

3 years relevant experience, experience in a GMP environment

Preferred Requirements

Masters degree in Chemistry, Biochemistry, Biology, Microbiology, or other relevant scientific discipline with 3+ years experience

degree in Chemistry, Biochemistry, Biology, Microbiology, or other relevant scientific discipline with 1+ years experience

One (1) year of experience in a GMP/GxP or a comparable federally regulated environment

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

Experience in assay troubleshooting and problem solving.

PHYSICAL DEMANDS

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 writs, 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.

ENVIRONMENTAL CONDITIONS

Will work in warm/cold environments 5C Range

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email .

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 place. 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.

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