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Aseptic Filling/ Formulation Process Owner SME

Employer
FUJIFILM Diosynth Biotechnologies
Location
Holly Springs, NC
Start date
Sep 30, 2022

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Discipline
Engineering, Manufacturing & Production, Science/R&D, Biotechnology
Required Education
Associate Degree
Position Type
Full time
Hotbed
Bio NC

Job Details

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.

 

Summary:

We are looking for an Aseptic Filling/ Formulation Production Process Subject Matter Expert (SME) who holds expertise in the areas of Drug Product Manufacturing, specifically formulation and aseptic filling. Some additional areas of your technical expertise may include manual and automated inspection, device assembly, and/ or label and pack operations. This finished goods experience is a plus. You will own the technical equipment processes and develop operational procedures and detailed design elements for the DP facility, ensuring our successful journey as we establish the largest end-to-end cell culture CDMO facility in North America.  A key area of focus will include supporting and leading the development of the process through coordination with the Manufacturing Sciences and Operational teams. Upon licensure of the Galaxy site, you will be key in leading the operational teams and the liaison between DP Manufacturing and Manufacturing Sciences, and will regularly engage with Senior Leadership, current and future customers, and various regulatory agencies. This is a key role for Fujifilm Diosynth Technologies with a high-level of visibility and expectation; it is also a unique opportunity to take your experience and career to the next level and beyond. The role will initially be reporting to the Head of Building Drug Product and Finished Goods, and ultimately report into the production organization as the project matures and the facility is operational.  As a project SME position, the incumbent's primary role is supporting the Process Lead, DP-FG.

 

External US

Job Responsibilities

 Project Phase:

  • Review Process Flow Diagrams (PFDs), PI&IDs, and other process and equipment design documents.
  • Review and/or author new User Requirement Specification (URS) documents and manage them through their lifecycle.
  • Provide process ownership and expertise to the Project Process Lead in support of the Drug Product aspects of the technical project.
  • Support FAT and SAT activities with travel local and abroad.
  • Engage with equipment providers and the selected project engineering services provider to assure proper design and installation details from an engineering and operational perspective.
  • Support equipment delivery milestones, construction field installation, consultation, and commissioning, validation and startup activity for respective areas of responsibility.

Operational Phase:

  • Provide support to all Tech Transfer work packages when transferring new products to the new facility in North Carolina. 
  • Provide SME support for issues and investigations post-Tech Transfer during commercial and clinical manufacturing
  • Work to drive standard work processes and adoption of best practices in validation, training, process changes, and handling of deviations and investigations. Collaborate with your FDB partners to ensure that quality, compliance improvement, and savings opportunities are applied globally.
  • Ensure robust product stewardship with a single point of contact for all products manufactured, with end-to-end technical oversight of product manufacturing processes.
  • Ensure the robustness of manufacturing and packaging processes, so that all products are validated and remain in a constant state of validation throughout their lifecycles, including monitoring each product's Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) thru a continued process verification program and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
  • Ensure appropriate input is provided for development of KPIs and methods of reporting to measure departmental and site performance.
  • Participate in development of the continuous improvement program of all production processes, including formulation, filling, visual inspection, assembly, labeling, and packaging.
  • Lead and support the optimization of pharmaceutical processes
  • Ensure appropriate technical standards for materials, production processes, and labeling & packaging, employing current concepts and technologies (e.g., Quality by Design (QbD), Design of Experiment (DOE), and Process Analytical Technologies (PAT)).
  • Designing and delivering technical training on processes to new employees
  • Lead and mentor all process development efforts towards most reliable process parameters (ranges) ensuring high uptime and minimizing possible product loss.
  • Acting as the interface with the relevant Health Authorities for technical issues.
  • Participate in customer meetings with new partners and products as well as relevant conferences, industry forums and trade fairs for competence development with possibility of representing FDBN in the wider industry through network building.

Preferred Requirements

  • Expertise in single use components in an aseptic formulation and filling operations.
  • Visual inspection experience is a plus.
  • 10+ years of experience within the pharmaceutical industry within aseptic manufacturing, project management a plus.
  • Aseptic formulation and filling expertise, with at least 5 years' experience specifically in these areas.

Basic Requirements

  • Expertise-level process knowledge within Drug Product manufacturing
  • Excellent communication skills and fluency in English
  • Experience in a cGMP facility or working with FDA regulations.
  • Associate's degree or Bachelor's degree in Engineering or Similar

The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

FDBN works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

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 lena.lee@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.

Company

Company info
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States

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