Director, Manufacturing and MSAT
1 week ago
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.
As a company liaison to CMOs, the Director ensures robust, healthy communication and oversight. 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).
ResponsibilitiesManage 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; Ensure all validation and re-validation work is conducted, reported, reviewed and approved per Validation Master Plans
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
Identify and lead continuous improvement initiatives; 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
Work closely with Forecasting and Analytics to provide CMO's with forecasts and Purchase Orders
Work closely with Customer Service to ensure streamlined delivery of product to 3PLs
Strive to reduce overall cost of goods and implement economies of scale
Responsible Subject Matter Expert and author of CMC sections of regulatory filings utilizing strong knowledge of FDA, EU and ICH requirements
Maintain knowledge of emerging process technologies and evaluate qualified CMO vendors
Prepare presentations for senior management to provide updates and facilitate decision-making
Participate in CMO audits
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; ensure active, productive, and supported development pathways
Education/Experience/Skills Requirements
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
Expert knowledge of cGMPs and U.S., 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
Strong Interpersonal skills, seasoned ability to influence
Strong verbal and written communication skills, responsiveness, and a high level of attention to detail
Demonstrated ability to hire, manage, coach, mentor and develop employees
Ability to thrive in a remote work environment
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