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.
Job DescriptionWhat You'll Do
Adheres to departmental budget and supports staff resourcing recommendations to meet organization goalsDevelops and executes departmental vision and strategy, overseeing the Process Validation and Material Science teamFosters long-term client relationships by ensuring successful project proposals and executionsWorks closely with different teams to ensure cohesive validation effortsProvides 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 productionDrives MSAT collaboration with cross-functional teams across the network, including Regulatory, Quality, Supply Chain, Validation, and Program ManagementAs local business process owner, oversees end-end process validation process, as well as viral security and contamination control strategy within the organizationDrives process validation methodology and strategy executionDrives technical leadership in the assessment of process validation requirements for new client programs, with focus on Drug Substance and Drug Product Biologics productionActively identifies gaps, suggests and drives implementation of improvements of Drug Substance Biologics production and Drug Product manufacturing capabilityEngages in technical reviewing and authoring of regulatory filings, and responds to questions received from regulatory agenciesCommunicates effectively process validation performance to key stakeholders (both internal-facing and client-facing)Manages and develops direct reportsAdministers 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 developmentParticipates in the recruitment process and retention strategies to attract and retain talent, as neededAddresses performance gaps, employee questions and concerns, and partners with HR as needed for resolutionPerforms other duties, as assignedKnowledge and Skills
Expert knowledge of process validation activities, particularly with PPQ and Continued Process Verification (CPV) stagesAdvanced knowledge of DSM and DPFG process equipment and unit operations (Large Scale Biologics production preferred)Advanced problem-solving and strong strategic skillsBuilds effective working relationships internally and externally to gain trust and viewed as a recognized expertDriven partner with global colleagues and leads sub teamsAbility to navigate through crucial conversationsAbility to lead large meetings, including cross-functional groups and external partnersAdvanced knowledge of Good Manufacturing Practices (GMP), EMEA and Food & Drug Administration (FDA) regulationsEffective communication, both written and oral, including feedback to others, including leadersAbility to adapt communication style to differing audiences and advise on difficult mattersStrong ability to mentor othersAbility to coach, lead, and develop individual contributorsAbility to effectively present information to othersMust be flexible to support 24/7 manufacturing facilityMinimum Requirements
Bachelor’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 13+ years of experience; ORMaster’s degree in Pharmaceutical, Biotech Manufacturing, Engineering or related field with 11+ years of experience10+ years of people management, leadership & team management experiencePreferred Requirements
Bachelor's/Master’s degree in Biochemical or Chemical EngineeringDirect experience in Large Scale (20KL Cell Culture Scale) Biologics Drug Substance manufacturingWorking & 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.
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