Process Science Tech Transfer Lead
4 weeks ago
Overview:
The Tech Transfer Lead includes the management and coordination of activities for products transferred into large scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This involves managing between different teams,
ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology
Major Accountabilities
Leads and supports technology transfer (TT) across multiple unit operation
Coordinates and leads regular meetings for TT programs with key stakeholders
Develops process performance qualification (PPQ) strategies specific for each program in collaboration with internal stakeholders and customers
Develops project plans that integrates with other scheduling functions within the organization and in alignment with program scope
Escalates risks and tracks milestone progress and ensure cross functional communication to key stakeholders
Supports Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, as required
Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques
Reviews and documents process performance and product health through process trending, monitoring, and supporting annual product reviews
Serves as point of contact to customer and internal regulatory team for technical aspects of the program
Identifies continuous improvements opportunities
Supports best practices for TT and PPQ strategies globally, as required
Coordinates, plans, and supports manufacturing process validation runs
Facilitates technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (e.g., databasing) and the statistical analysis aimed at both process monitoring and
continued process verification
Writes documentation for internal and external use, such as manufacturing campaigns summary reports, PPQMP (Process Performance
Qualification Master Protocol and reports, impact assessments etc.
Interprets and utilizes new knowledge to promptly drive data-based decisions
Collaborates with manufacturing department to support commercial and clinical manufacturing campaigns
Minimum Requirements
Bachelors degree in engineering, Life Science or Chemical
Engineering with 5 years of relevant experience (e.g.,
manufacturing); or
Masters degree with 3 years of experience; or
PhD with no prior experience
Preferred Requirements
Experience working in a Good Manufacturing Practices (GMP)
environment
Prior drug substance or manufacturing experience, including process
validation, transfer, commercialization, and manufacturing support
and troubleshooting
Experience using quality systems (e.g., deviation management
system, change control, corrective and preventive action (CAPA),
document management system)
Experience with root cause analysis (RCA) and risk management tools
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
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
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