The Director, Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) organization. The role responsibilities encompass leading and overseeing all process validation, including material science aspects, to ensure the robustness, efficacy, and compliance of manufacturing processes. his role requires strategic leadership, technical expertise, and cross-functional collaboration to drive continuous improvement and adherence to regulatory standards. The Director, Process Validation is crucial in enhancing the site’s process validation capability offerings and maintaining competitiveness by making significant contributions to the company’s growth and innovation.

What You'll Do

• Adheres to departmental budget and supports staff resourcing recommendations to meet organization goals
• Develops and executes departmental vision and strategy, overseeing the Process Validation and Material Science team
• Fosters long-term client relationships by ensuring successful project proposals and executions
• Works closely with different teams to ensure cohesive validation efforts
• Provides scientific and strategic leadership for process validation and verification with internal and external stakeholders and ensures successful execution of Process Performance Qualification (PPQ) plans and post-launch commercial activities for Biologics Drug Substance and Drug Product production
• Drives MSAT collaboration with cross-functional teams across the network, including Regulatory, Quality, Supply Chain, Validation, and Program Management
• As local business process owner, oversees end-end process validation process, as well as viral security and contamination control strategy within the organization
• Drives process validation methodology and strategy execution
• Drives technical leadership in the assessment of process validation requirements for new client programs, with focus on Drug Substance and Drug Product Biologics production
• Actively identifies gaps, suggests and drives implementation of improvements of Drug Substance Biologics production and Drug Product manufacturing capability
• Engages in technical reviewing and authoring of regulatory filings, and responds to questions received from regulatory agencies
• Communicates effectively process validation performance to key stakeholders (both internal-facing and client-facing)
• Manages and develops direct reports
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Knowledge and Skills

• Expert knowledge of process validation activities, particularly with PPQ and Continued Process Verification (CPV) stages
• Advanced knowledge of DSM and DPFG process equipment and unit operations (Large Scale Biologics production preferred)
• Advanced problem-solving and strong strategic skills
• Builds effective working relationships internally and externally to gain trust and viewed as a recognized expert
• Driven partner with global colleagues and leads sub teams
• Ability to navigate through crucial conversations
• Ability to lead large meetings, including cross-functional groups and external partners
• Advanced knowledge of Good Manufacturing Practices (GMP), EMEA and Food & Drug Administration (FDA) regulations
• Effective communication, both written and oral, including feedback to others, including leaders
• Ability to adapt communication style to differing audiences and advise on difficult matters
• Strong ability to mentor others
• Ability to coach, lead, and develop individual contributors
• Ability to effectively present information to others
• Must be flexible to support 24/7 manufacturing facility
  

Minimum Requirements

• Bachelor’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 13+ years of experience; OR
• Master’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 11+ years of experience
• 10+ years of people management, leadership & team management experience

Preferred Requirements 

• Bachelor's/Master’s degree in Biochemical or Chemical Engineering
• Direct experience in Large Scale (20KL Cell Culture Scale) Biologics Drug Substance manufacturing

Working & Physical Conditions

Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

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.