Director, Manufacturing and MSAT

Position Overview
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).

Responsibilities

1. Manage and oversee direct contract manufacturing and MSAT functions, ensuring continuous commercial product supply.
2. Ensure commercial and clinical DS, DP and finished goods are manufactured and released in compliance with company procedures and regulatory requirements.
3. Manage validation efforts at CMO sites; Ensure all validation and re-validation work is conducted, reported, reviewed and approved per Validation Master Plans.
4. Provide scientific and technical direction to the internal team and contract CMOs.
5. Evaluate, develop and execute processes for selection and management of commercial and clinical suppliers in collaboration with extended team.
6. Work with Project Management to lead process and technology transfer including assessment of scaled models and evaluation of fit.
7. Identify and lead continuous improvement initiatives; Perform risk assessments.
8. Work with functional areas to create and manage integrated strategic plans for special projects.
9. Act as a liaison for CMO relationships, key member of interdisciplinary project teams representing the manufacturing/MSAT function at Joint Steering Committee meetings.
10. Partner with key stakeholders in the preparation and negotiation of Supply Agreements and Quality Agreements.
11. Work closely with Forecasting and Analytics to provide CMO’s with forecasts and Purchase Orders.
12. Work closely with Customer Service to ensure streamlined delivery of product to 3PLs.
13. Strive to reduce overall cost of goods and implement economies of scale.

1. Responsible Subject Matter Expert and author of CMC sections of regulatory filings utilizing strong knowledge of FDA, EU and ICH requirements.
2. Maintain knowledge of emerging process technologies and evaluate qualified CMO vendors.
3. Prepare presentations for senior management to provide updates and facilitate decision-making.
4. Participate in CMO audits.
5. Perform process monitoring, batch record review, technical troubleshooting, investigations, change control, deviation assessment and corrective actions as needed.
6. Act as in-plant oversight of batch manufacturing as needed.

1. Drive program risk management using proactive identification of key risks and facilitation of mitigation and contingency planning.
2. Develop cost estimates and staffing requirements for projects, and managing the manufacturing budget.
3. Develop departmental budgets in collaboration with Vice President, Program Management & Operations.
4. Hire, mentor and coach staff; ensure active, productive, and supported development pathways.

Education/Experience/Skills Requirements

1. Bachelor’s in Biochemistry, Biology, Chemical Engineering, Bioengineering, Pharmaceutical Technology or related discipline, MS or PhD preferred.
2. A minimum of 10 years in Biotech/Pharma.
3. Deep expertise in late-phase/commercial-phase mammalian biologics manufacturing (downstream drug substance and drug product), small molecule and cytotoxics.
4. Minimum of 5 years of people management.
5. Hands-on experience in a cGMP manufacturing environment desired.
6. Expert knowledge of cGMPs and U.S., EU, and Rest of World (ROW) regulatory standards.
7. Excellent analytical skills, skilled at developing processes to evaluate, track and trend manufacturing outputs.
8. Expert data analysis skills using JMP, Excel.
9. Experience with regulatory agency inspections, authoring CMC sections.
10. Strong Interpersonal skills, seasoned ability to influence.
11. Strong verbal and written communication skills, responsiveness, and a high level of attention to detail.

1. Demonstrated ability to hire, manage, coach, mentor and develop employees.
2. Ability to thrive in a remote work environment.