Director, Manufacturing and MSAT Job at Medexus Pharma, Inc in Chicago

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus’ current focus is on the therapeutic areas of hematology, oncology, auto-immune diseases, and allergy.

Position Overview
The Director, Manufacturing and MSAT will work in a small, dynamic team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management and development of direct reports and for management of 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).

Position Responsibilities

• 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
• Develop selection processes for commercial and clinical suppliers in collaboration with extended team
• 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 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

• Author CMC sections of regulatory filings utilizing strong knowledge of FDA, EU and ICH requirements
• Maintain knowledge of emerging process technologies
• 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
• Develop departmental budgets in collaboration with Vice President, Compliance & US Operations
• Hire, mentor and staff; ensure active, productive, and supported development pathways

Education, Experience & Skill Requirements

• Experience: Minimum 10 years in Biotech/Pharma, including 5 years in people management with expertise in late-phase mammalian biologics, small molecules, and cytotoxics
• Analytical and Product Development Skills: expert analytical and data analysis skills (JMP, Excel), database build and management, DoE, study design
• cGMP Proficiency: hands-on experience in a cGMP environment
• Regulations: expert knowledge of U.S., EU, and ROW regulatory standards, familiarity with regulatory inspections, experience authoring CMC sections and supplements
• Team Leadership and Development: demonstrated ability to hire, coach, and develop a high-performing team
• Strategic Leadership: develop and implement strategies aligned with organizational goals, seasoned ability to influence
• Communication: strong interpersonal, verbal, and written communication skills with extensive experience presenting information to and working with internal ad external stakeholders
• Project Management: proven track record in managing complex projects using methodologies like Agile or Six Sigma
• Tech Transfer: experience transferring processes from R&D to commercial
• Budget Management: financial oversight and budget management experience
• Collaboration: proven ability to thrive in a cross-functional, matrixed environment
• Continuous Improvement: commitment to fostering a culture of innovation and efficiency
• Crisis Management: Resilience and problem-solving skills in operational crises
• Emerging Technologies: informed about advancements in manufacturing technologies and innovations
• Remote work: proven ability to engage and thrive in a remote work environment

Additional Information
Travel: 20%
Salary Range: $180,000 - $205,000
Location: Remote

Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our employees, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at careers@medexus.com to request accommodation.