Position OverviewJoin a team where your upstream expertise directly impacts large-scale biologics production. If you enjoy solving complex challenges, leading technology transfers, and partnering with manufacturing to bring therapies to patients, this role offers the scope, autonomy, and collaboration to make a real difference.
Job DescriptionResponsibilities- Conduct lab and pilot-plant experiments to support upstream development and scale-up
- Generate and coordinate execution of sampling protocols for development, validation, and investigations
- Serve as a subject matter expert to lead and conduct troubleshooting, process impact assessments, root cause analysis (RCA), and corrective and preventive actions (CAPA) in response to deviations
- Execute and analyze lab and pilot work to solve complex manufacturing problems
- Lead and support technology transfer across multiple upstream 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; consult on topics related to manufacturing and process performance
- Lead technical risk assessments for new manufacturing processes
- Contribute to manufacturing data management (including databasing) and perform statistical analyses for process monitoring and continued process verification
- Write documentation for internal and external use, such as campaign summary reports, process performance qualification (PPQ) protocols and reports, and impact assessments
- Lead training of manufacturing and process science staff on new processes, procedures, and equipment
- Interpret and apply new knowledge promptly to drive data-based decisions
- Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
- Lead continuous improvement initiatives to enhance manufacturability, reliability, yield, and cost
- Support supplier technical evaluations, risk assessments, and raw material evaluation and qualification
- Perform other duties, as assigned
Minimum Qualifications- Associate degree in Engineering, Life Science, or Chemical Engineering with 8 years of 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); or
- Master's degree with 3 years of related work experience; or
- PhD with no prior experience
Preferred Qualifications- Large-scale manufacturing experience with CHO cell processes and monoclonal antibody production
- Experience using quality systems (e.g., deviation management, change control, CAPA, document management)
- 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
Knowledge, Skills, and Abilities- Proficient knowledge of Design of Experiments (DOE) and Statistical Process Control (SPC)
- Advanced problem-solving and data analysis skills; experience with risk management and RCA tools
- Effective written and verbal communication; strong presentation skills
- Proficient project management and the ability to lead cross-functional efforts
- Ability to provide constructive feedback and influence stakeholders, including senior partners
- Strong collaboration skills; builds effective internal and external relationships
- Adapts communication style to differing audiences and advises others on complex matters
Working Environment and Physical Requirements- Typical lab/office environment; no routine requirement for respiratory protection, hearing protection programs, or powered industrial truck operation
- Ability to discern audible cues
- No routine requirements for lifting thresholds, prolonged standing or sitting, repetitive motions, climbing, operating machinery, or work at heights
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.
