Funeral director Jobs in Meridian, ID

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 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 the 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 the Vice President, Compliance & US Operations.
• Hire, mentor, and staff; ensure active, productive, and supported development pathways.

Education, Experience & Skill Requirements

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 [email protected] to request accommodation.

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