Associate Director, Analytical Development

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 solutionsto 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 The Role

The Associate Director, Analytical Development, is responsible for directing and overseeing the development and method transfer of analytical methods from external clients to FDBN Quality Control (QC) teams to support drug substance and drug product manufacturing. The AD, Analytical Development leads the Analytical Development team to achieve key functional, strategic, tactical and operational objectives in support of raw material, in-process, drug substance, and drug product testing. This position interfaces with customers, program teams, and scientific teams to scope analytical testing plans, plan resource allocations, and achieve project milestones. This role also authors/reviews transfer plans, method transfer documents, transfer summary reports

and specification justification reports, as needed.

What You'll Do

• Interfaces with customers and program management teams to identify analytical needs and perform gap assessments during project scoping• Works with customers and the Tech Transfer team to review and implement QC analytical testing methods • Serves as the subject matter expert (SME) to review and deliver SOPs, transfer plans, protocols, reports, transfer summary reports and specification justification reports • Leads the AD team to qualify, validate and transfer analytical testing methods, in support of in-process, release and stability testing• Liaises with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines• Coordinates various AD activities including change control assessment activities for the implementation of new raw materials, transfer of methods, and specifications updates• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.)• Drives the evaluation and incorporation of automation into QC analytical testing methods, as appropriate• Identifies, evaluates, develops and implements new analytical technologies and strategies that lead to process improvements and efficiency of operation• Supports regulatory requests and inspections• Ensures the analytical team understands business goals and delivers results according to project deadlines• Manages the QC AD team which includes planning, goal setting, ensuring employees understand their duties and responsibilities, providing direction, giving feedback, conducting performance evaluations, assisting in growth and professional development• Ensures all employees are properly trained and comply with safety standards• Responsible for growing the QC AD team by identifying resourcing gaps, drafting job descriptions, evaluating potential candidates, performing interviews and selecting new employees• Performs other duties, as assigned

Minimum Requirements:

• Bachelor's degree with 12 years' experience OR• MS degree with 8 years' experience OR• PhD with 6 years' experience • 3+ years of previous experience in a leadership role

• Demonstrated expertise in the development of analytical methods

for release and characterization of recombinant biopharmaceutical

proteins• Demonstrated ability to design, manage and execute analytical

studies to support the development and cGMP manufacturing of

recombinant biopharmaceutical proteins• Experience working in a regulated GMP environment• Experience managing and developing direct reports and teams• Extensive experience with analytical methods, especially those

involving protein analysis

Preferred Requirements:

• Experience working in a contract manufacturing or testing

organization

Physical Requirements:

• Ability to ascend or descend ladders, scaffolding, ramps
• Ability to stand for prolonged periods of time up to 60 minutes
• Ability to sitfor prolonged periods of time up to 60 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 using twisting motions

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 [email protected].

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.