Location: Chicago,IL, USA
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 FDAs 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 CMOs 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 ...@medexus.com to request accommodation.