Remote Manufacturing Planning Director

Found in: Jooble US O C2 - 3 weeks ago

Chicago IL, United States Page Mechanical Group, Inc. Full time

The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. The Director will provide technical and scientific subject matter expertise for Drug Substance, Drug Product, and Finished Product manufacturing. The candidate will interact and collaborate with QA, QC, Regulatory Affairs, Forecasting and Analytics, Clinical, Commercial Operations and Operations team members to fulfill Medexus’ commitment to patients and the FDA’s mandate for Continued Process Verification (CPV).
Manage and oversee direct contract manufacturing and MSAT functions, ensuring continuous commercial product supply
Ensure commercial and clinical DS, DP and finished goods are manufactured and released in compliance with company procedures and regulatory requirements
Manage validation efforts at CMO sites; Provide scientific and technical direction to the internal team and contract CMOs
Evaluate, develop and execute processes for selection and management of commercial and clinical suppliers in collaboration with extended team
Work with Project Management to lead process and technology transfer including assessment of scaled models and evaluation of fit
Perform risk assessments
Work with functional areas to create and manage integrated strategic plans for special projects
Act as a liaison for CMO relationships, key member of interdisciplinary project teams representing the manufacturing/MSAT function at Joint Steering Committee meetings
Partner with key stakeholders in the preparation and negotiation of Supply Agreements and Quality Agreements
Responsible Subject Matter Expert and author of CMC sections of regulatory filings utilizing strong knowledge of FDA, EU and ICH requirements
Prepare presentations for senior management to provide updates and facilitate decision-making
Perform process monitoring, batch record review, technical troubleshooting, investigations, change control, deviation assessment and corrective actions as needed
Act as in-plant oversight of batch manufacturing as needed
Drive program risk management using proactive identification of key risks and facilitation of mitigation and contingency planning
Develop cost estimates and staffing requirements for projects, and managing the manufacturing budget
Develop departmental budgets in collaboration with Vice President, Program Management & Operations
Hire, mentor and coach staff; Bachelor’s in Biochemistry, Biology, Chemical Engineering, Bioengineering, Pharmaceutical Technology or related discipline, MS or PhD preferred
A minimum of 10 years in Biotech/Pharma
Deep expertise in late-phase/commercial-phase mammalian biologics manufacturing (downstream drug substance and drug product), small molecule and cytotoxics
Minimum of 5 years of people management
Hands-on experience in a cGMP manufacturing environment desired
EU, and Rest of World (ROW) regulatory standards
Excellent analytical skills, skilled at developing processes to evaluate, track and trend manufacturing outputs
Expert data analysis skills using JMP, Excel
Experience with regulatory agency inspections, authoring CMC sections
Demonstrated ability to hire, manage, coach, mentor and develop employees
Ability to thrive in a remote work environment
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