What You’ll Do
- Supports the team with the introduction of new raw materials, and associated document requirements
- Assesses vendor change notifications, and provides input on raw materials related matters
- Supports change requests for introduction, modification, and discontinuation of raw materials
- Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
- Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
- Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
- Supports process sub-teams throughout the phases of technology transfer (TT)
- Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
- Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
- Supports generation of sampling plans for process validation reports (PVRs) and investigations
- Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
- Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost
- Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives
- Other duties, as assigned
Knowledge and Skills
- Builds connections with key contacts within the department and outside specialty
- Communicates effectively within the team
- Engages in important conversations with cross-functional team members
- Develops basic hypotheses for projects
- Possesses fundamental project management skills. Effectively communicates information to others
- Thinks critically and self-directed with minimal oversight
- Understands basic project management and quality systems (e.g., Change Control, document management system)
- Strong communication and teamwork skills
- Solid grasp of material investigation methods Stays informed about regulatory and quality requirements in manufacturing
- Knowledgeable of material investigation principles and techniques
Basic Requirements
- Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; OR
- Master’s degree in Engineering, Life Science or Chemical Engineering with no relevant experience
- Experience working in a Good Manufacturing Practices (GMP) environment
Preferred Requirements
- Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting
- Experience supporting the following:
o Writing portions of regulatory filings and regulatory audits
o New product launches and validation of process
o Global or multi-site validation programs
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.