QC Manager, Raw Materials

Overview

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

The work we do at FDB 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 FDB 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.

External US

About This Role

The Manager, QC Raw Materials Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager, QC Raw Materials is responsible for managing raw material specifications, handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition, the QC Raw Materials team is responsible for testing, disposition, and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager, QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

What You'll Do

• • Ensures GMP compliant laboratory operations according to guidelines• Manages the daily activities of the QC Raw material team and assuring dedicated focus on testing, release, change management and Tech Transfer activities in support of new and existing customer programs• Ensures overall performance of QC Raw Material team according to KPIs. Assures turn-around-times of all testing, raw material approvals and supporting drug substance and drug product manufacturing production.• Oversees and manages laboratory exceptions and investigations and assures timely closure of cGMP KPI deliverables within the group• Motivates the group to perform as efficiently as possible to reduce turn-around-times for testing, approval and ensures manufacturing is running and tech transfer activities timelines are met• Authors procedures, documents and reports, as needed, to support the QC Raw Materials team and tech transfer activities• Leads projects for tech transfers by having dialogues with customers around customer owned and FDB owned materials, etc.• Prioritizes and focuses on optimized laboratory systems, including the use of IT systems (e.g. Labware), identifies and implements needed procedural and/or policy changes in areas where needed. Enforces established policies, processes and procedures and identifies areas where enhancements will improve daily work• Leads cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives• Authors, reviews, and approve data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as needed• Ensures the team and laboratory maintains inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processes• Ensures the timely delivery of results within deadlines by effectively managing the performance of the QC Raw Material Team• Represents QC in relevant internal and external cross-functional meetings and projects to ensure delivery of QC Raw Material objectives• Executes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team members• Supports management activities related to compliance with policies, appropriate personnel training, providing feedback for personnel development, and effective and timely decision making/corrective actions on the floor• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree with 8+ years of experience in a GMP environment OR• Master's Degree with 6+ years of experience in GMP environment OR• Ph.D. with 4+ years of experience in GMP environment• 5+ years of experience with analytical testing, preferably raw material testing and release• Previous QC Raw Materials Management experience

Preferred Requirements:

• Master's degree or Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree with 6+ years of GMP experience OR• Ph.D. in Chemistry, Microbiology, Biological Sciences with 4+ years of GMP experience• Previous experience with analytical testing, preferably raw material testing and release in the biopharmaceutical industry• Experience with Microsoft Office, Smartsheet and laboratory LIMS and ERP systems (e.g., SAP)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to stand for prolonged periods of time up to 120 minutes.

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

• Ability to conduct work that includes moving objects up to 33 pounds.

• Ability to conduct repetitive motions that include writs, hands and/or fingers

• Ability to operate machinery and/or power tools

• Ability to work in cold environments (5C)

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

• Will work in heights greater than 4 feet

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 FDBN_PNC@fujifilm.com.

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.