Process Analysis Design: Assess current MST processes to identify inefficiencies, gaps, and risks. Develop and implement process improvement strategies aligned with regulatory and business requirements. Create detailed process maps, workflows, and documentation.
Stakeholder Collaboration: Work closely with MST teams, Quality, Regulatory, and IT to gather requirements. Facilitate workshops and meetings to drive process discussions and secure stakeholder buyin.
Change Management: Lead change initiatives, including training and communication plans. Ensure smooth adoption of new processes and technologies.
Compliance Governance: Ensure processes adhere to GMP, GxP, and other regulatory standards. Conduct audits and reviews to maintain compliance.
Performance Monitoring: Define KPIs and monitor effectiveness of implemented processes. Recommend adjustments based on performance data and feedback.
Education
Bachelor's or Master's in Engineering, Life Sciences, Business, or related field.
Experience
5+ years in business process consulting or MST operations.
Strong knowledge of manufacturing processes, technology transfer, and regulatory compliance.
Proficiency in process mapping tools e.g., Visio, ARIS and data analysis.
Familiarity with Lean, Six Sigma, or other process improvement methodologies.
Excellent communication, facilitation, and stakeholder management skills.
Ability to manage multiple projects and deliver within timelines.
Preferred Skills
Experience in pharmaceutical or biotech MST environments.
Knowledge of digital transformation tools and automation technologies.
Project management certifications PMP, PRINCE2 are a plus.
Required Skills
Business Analysis (BA), Process Mapping, Customer liaison, Reporting, Agile & Lean Methodologies, Life Sciences Domain Knowledge, Stakeholder Management and Data Analysis