Engineer / Scientist 3, Downstream - MSAT

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled Engineer/Scientist to provide technical oversight for large-scale purification activities. In this dynamic role, you will conduct lab experiments, lead troubleshooting efforts, and support technology transfer across multiple unit operations. You will collaborate closely with manufacturing teams to enhance processes and ensure high-quality outputs. This position offers a unique opportunity to contribute to groundbreaking biopharmaceutical manufacturing in a state-of-the-art facility. If you are passionate about making a real impact in the life sciences sector, this role is perfect for you.

Qualifications

• Experience in large scale manufacturing support with chromatography and viral filtration.
• Proficient in using quality systems and risk management tools.

Responsibilities

• Conduct lab and pilot plant experiments to solve manufacturing problems.
• Lead technology transfer and coordinate manufacturing process validation runs.

Skills

Design of Experiments (DOE)

Statistical Process Control

Effective communication

Project management

Advanced problem-solving

Education

Associate degree in Engineering, Life Science or Chemical Engineering

Bachelor’s degree in Engineering, Life Science or Chemical Engineering

Master’s degree

PhD

Tools

Quality systems

Risk management tools

Job description

Position Overview

The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

Company Overview

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

What You’ll Do

• Conduct lab and pilot plant experiments.
• Generate and coordinate execution sampling protocols.
• Serve as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and execute root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations.
• Execute and analyze lab and pilot plant work aimed at solving complex manufacturing problems.
• Lead and support technology transfer (TT) across multiple unit operations.
• Coordinate, plan, and execute manufacturing process validation runs.
• Support design and lead generation of sampling plans for process validation reports (PVRs) and investigations.
• Write and review master batch records (MBRs) and standard operating procedures (SOPs), as needed.
• Generate and execute process training and consult on topics related to manufacturing and process.
• Lead technical risk assessments for new manufacturing processes.
• Contribute to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification.
• Write documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments, etc.
• Lead training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab.
• Interpret and utilize new knowledge to promptly drive data-based decisions.
• Collaborate with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support.
• Lead continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield, and cost.
• Support supplier technical evaluations, risk assessments, and raw material evaluation and qualification.
• Other duties, as assigned.

Knowledge and Skills

• Proficient knowledge in Design of Experiments (DOE).
• Proficient knowledge in Statistical Process Control.
• Effective communication, both written and oral.
• Ability to effectively present information to others.
• Proficient project management skills.
• Advanced problem-solving skills.
• Ability to provide feedback to others, including leaders.
• Ability to develop effective working relationships internally and externally.
• Ability to adapt communication style to differing audiences and advise others on difficult matters.

Basic Requirements

• Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing).
• Master’s degree with 3 years of related work experience; or
• PhD with no prior experience.
• Large scale manufacturing support experience with chromatography for several types of chromatographic mediums operations, viral filtration, ultrafiltration, and bulk filling, troubleshooting, and deviation support.
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system).
• Experience using risk management and RCA tools.

Preferred Requirements

• Experience in contract manufacturing or interacting with contract manufacturers.
• Experience working in a Good Manufacturing Practices (GMP) environment.
• Prior drug substance and manufacturing experience, including process development, validation, and transfer.

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in an environment which may necessitate respiratory protection. May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. Will work in an environment operating a motor vehicle or Powered Industrial Truck. Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time. Ability to sit for prolonged periods of time. Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers. Ability to operate machinery and/or power tools. Ability to conduct work that includes moving objects up to 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).