QC Manager, Bioassay/Virology

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, Bioassay/Virology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at Fujifilm Diosynth Biotechnologies. The Manager, Bioassay/Virology is accountable for GMP compliant laboratory operations according to regulatory guidelines. This role is responsible for direct management and supervision of the Bioassay & Virology team performing ELISAs, Potency assays, residual DNA/Host Cell Protein/Protein A assays, qPCR assays and Adventitious Virus testing. The Manager, Bioassay/Virology is the technical subject matter expert (SME) with in‐depth knowledge of QC analytical methods including: ELISAs, potency assays, qPCR assays, residual DNA/Host Cell Protein/Protein A assay, Adventitious Virus testing. This role provides 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 that all reported results are accurate. The Manager participates actively in leading the QC Bioassay/Virology team and managing day‐to‐day activities of team. The Manager represents QC Bioassay/Virology during customer and regulatory audits. The Manager is accountable for modeling leadership competencies and aid in the development of QC team members.

What You'll Do

• Ensures GMP compliant laboratory operations according to GMP guidelines

• Manages the daily activities of the QC Bioassay & Virology together with the planners in the team, and assuring dedicated focus on release, stability and clinical testing, including prioritizing work

• Ensures overall performance of QC Bioassay & Virology according to KPIs ‐ assuring turn‐around‐times of all release, stability and clinical testing performed in the QC Bioassay & Virology department

• Assures timely analysis, review and approval of results in support of on time CoA issuance or stability time point

• Oversees and manage laboratory exceptions and investigations and assure timely closure within the group according to Quality metrics

• Motivates the group to perform as efficient as possible to reduce turn‐around‐times for release of commercial, stability and clinical products.

• Manages and prioritizes the preparation of procedures, protocols and associated reports for various deliveries.

• Leads projects, like method transfers and method qualifications in support of new product introduction for new and existing customers.

• Prioritize and focus on optimized laboratory systems, including the use of IT systems, e.g. Labware, identify and implement needed procedural and/or policy changes in areas where needed.

• Enforce established policies, processes and procedures and identifies areas where enhancements will improve daily work

• Leads a team responsible for executing analytical methods that require aseptic techniques including: viral infectivity assays, qPCR assays, cell‐based assays, and clean cell culture

• Manages, directs and monitors lab activities and team as needed

• Leads method verification, qualification, and validation activities and maintain lab equipment

• Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations and investigations for the QC Bioassay/Virology team as needed

• Ensures department is ready for customer visits, audits and regulatory inspections

• Performs investigations, manages complex issues, barriers, and problems to support team success

• Approves data reports within the team and area of discipline/focus, including approval of results

• Supports management for activities related to compliance with policies

• Provides leadership and mentoring as needed to aide in the development of the team

• Provides technical leadership through effective project management, status tracking including analytical improvement projects and technical problem solving with independence

• Proactively identifies technical gaps and areas for improvement related to quality

• Represents QC Bioassay/Virology on cross‐functional Tech Transfer teams in support of implementing, transferring, and/or validating client methods ahead of new program campaigns

• Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management

• 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

• Previous QC Bioassay and Virology leadership experience

• Advanced knowledge in Bioassay and Virology testing methods

Preferred Requirements:

• Previous QC Bioassay and Virology leadership experience in a GMP environment

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 activities using repetitive motions that include writs, hands and/or fingers.

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

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

• Ability to work in environments between

• 20 and

• 70 C for a few minutes with appropriate PPE

• 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.