Associate Director Material Sciences Large Molecules MSAT Lead

Job Description - Associate Director Material Sciences Large Molecules MSAT Lead W)

Description

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Material Sciences is a technical and scientific department within MSAT Large Molecules Drug Substance organization. We are building our team to strengthen our connectivity and support the drug substance and drug product manufacturing network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The Associate Director Material Sciences Large Molecules MSAT Lead will have a proven track record of applying in-depth conceptual knowledge of materials science and engineering principles to materials and improved process understanding.

This position will require the ability to work independently, be self-motivated, be collaborative to build a strong foundation and operate in a cross -functional environment. This position may be site based, based on candidate's fit and experience.

Key Responsibilities:

• Lead a team of scientists and engineers supporting the qualification controls and transfer of raw materials including internal laboratories and contract laboratories.
• Represent the MSAT function in cross-functional teams as a materials science leader for single-use systems, cell culture media, and/or large molecule raw materials.
• Support and champion continuous improvement and technical innovation within the large molecules manufacturing network with respect to raw materials.
• Establish procedures and business processes to conduct raw material technical assessments, support onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.
• Demonstrates unmistakable intellectual and/or technological leadership on material science projects.
• Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.
• Engage industry to identify best practices and improvement opportunities.
• In partnership with procurement and quality, plan and execute technical due diligence assessments and visits with raw material suppliers and contract manufacturing organizations (CMOs);
• Support of technology transfer and site readiness for raw materials at commercial manufacturing sites including internal sites and CMOs;
• Investigation of complex material-related product and process deviations and manufacturing investigations.
• Design and implement robust and operationally efficient business process methodologies and tools to promote a robust portfolio level management of projects.
• Collaborate with technical and quality partners at CMOs on the definition of controls for raw materials including support of supplier and material qualification.Partner with API and Drug Product development teams for material selection, assessments, and control strategies for LCM products.
• Support technology transfer of materials used in commercial supply chain throughout product life cycle partnering closely with technical, procurement, regulatory and quality partners.
• Interpret and implement industry and regulatory guidance for raw materials, e.g., USP/EP/JP, ICH, FDA and EMA. Ensure safety and compliance with GMP, quality, and scientific principles.

Nature of Communication

• Communicates overall strategy and results of the projects to others.
• Serves as the liaison between team members and senior leadership.
• Influences across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions.
• Negotiates and solicits acceptance of new ideas, approaches, concepts through scientific leadership.

Program/Project Management

• Has direct responsibility for budget and resource allocation on a project.
• Sets and monitors priorities, budget, timeline and resources for team.
• Influences the initiation, development and termination of projects in a timely manner.
• Advises on current procedures and assesses potential improvements across products and processes.

Qualifications

• The candidate has preferably a Ph.D. degree in Chemistry, Biochemistry Pharmaceuticals, Engineering, or a Master Degree with equivalent training/ experience.
• A Minimum of 10 years of experience in Drug Substance pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education is required and people leadership experience.
• Proven track record in leading technical/scientific team(s) and direct people management experience.
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
• Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio.
• Motivated, self-starter able to work independently with demonstrated problem solving skills is required.

Preferred:

• Demonstrated proficiency leading direct reports in complex technical projects is preferred.
• Demonstrated proficiency in knowledge of raw materials including cell culture media, chemicals and excipients in biotherapeutic products is preferred.
• Demonstrated competency and experience in quality investigations, change control, troubleshooting and regulatory submissions is preferred.
• Demonstrated experience with managing contract laboratories is preferred.
• Demonstrated competency and experience in technology transfer, or investigations within the biopharmaceutical industry is preferred.

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