Director, Process Validation

Fujifilm•Holly Springs, NC

11d

About The Position

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.

Requirements

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
Bachelor’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 10+ years of experience; OR Master’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 8+ years of experience
6+ years of people management, leadership & team management experience

Nice To Haves

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

Responsibilities

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