Location: Holly Springs,NC, USA
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 Process Science (PS) Lab Manager is responsible for staffing and execution of the PS Lab. This lab is critical to performing various studies such as client establishment runs (scale-down model), satellite runs, hold time studies and investigation support. The Manager secures a well-functioning lab environment, including responsibility for daily management of the team, service and maintenance of the PS lab equipment and inventory management. The Manager provides technical support and troubleshooting of laboratory experiments for both upstream and downstream unit operations. The role involves collaboration with other teams in PS and other departments within the facility. Additionally, this role supports the improvement of workflows in the lab, implementation of new technologies, and planning and prioritization of projects within the lab.
What You'll Do
* Manages the lab team, schedule, processes, etc.
* Develops the team strategy and short and long-term goals to meet organizational needs
* Provides support and direction for the lab by utilizing technical knowledge and expertise
* Oversees efficient and effective lab operations (e.g., clean, and organized environment)
* Manages inventory to ensure adequate supplies and equipment are readily available
* Oversees the quality of experiments and navigates the team through troubleshooting any issues
* Enforces good lab practices and data integrity of the data generated, compliance with good laboratory practice (GLP) and other safety standards
* Ensures experimental data is summarized succinctly and communicated to key stakeholders
* Serves as a coach and technical mentor to direct reports to foster professional development and growth
* Participates in the recruitment process and retention strategies to attract and retain talent
* Addresses performance gaps, employee concerns, and partners with HR, as needed for resolution
* Other duties, as assigned
Knowledge and Skills
* Ability to collaborate with all departments at a site and global level
* Effective communication, both written and oral
* Ability to provide feedback to others, including leadership
* Demonstrates strong organizational skills and project management capabilities
* Actively champions continuous improvement practices and ideas
* Ability to summarize experiments data and conclusions and communicate to required stakeholders
* Actively champions a safe workplace for all employees and contractors in the lab
* Knowledge of GMP systems and operations
Basic Requirements
* Bachelor's degree in Biology, Chemistry, Engineering or related field with 12 years of relevant experience (e.g., manufacturing, laboratory)
* 2-3 years of managing, leading, and developing a team of scientists, engineers, or technicians
* Experience with lab operations (e.g., biotech labs)
* Experience troubleshooting lab experience and equipment
* Experience summarizing data and conclusions from experiments
Preferred Requirements
* Experience with CHO cell culture processes (Upstream and Downstream), including scaling up
* Experience with Manufacturing Science and Technology (MSAT) labs
* Experience working in a GMP environment
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions. No X Yes
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 ...@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.