What You’ll Do
Conducts lab and pilot plant experiments
Generates and coordinates execution sampling protocols
Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
Leads and supports technology transfer (TT) across multiple unit operation
Coordinates, plans, and executes manufacturing process validation runs
Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
Generates and executes process training and consults on topics related to manufacturing and process
Leads technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (i.e., 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, process performance qualification (PPQ) protocol and reports, impact assessments etc.
Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
Interprets and utilizes new knowledge to promptly drive data-based decisions
Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
Other duties, as assigned
Knowledge and Skills
Proficient knowledge in Design of Experience (DOE)
Proficient knowledge in Statistical Process Control
Effective communication, both written and oral
Ability to effective 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 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
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 working in a Good Manufacturing Practices (GMP) environment
Prior drug substance and manufacturing experience, including process development, validation, and transfer
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
- Ability to discern audible cues.
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.