As a key member of the Global Biologics Product Stewardship team, this individual will be responsible for providing technical leadership to cross-functional forums. This individual will lead teams and set the needed strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle. This individual will lead or contribute as a key member of various cross-functional teams focused upon product development and commercial product support. This individual will interact extensively with other departments, including process and formulation development, analytical development, commercial manufacturing, QA, QC, engineering, supply chain, validation, tech transfer, and regulatory functions. This role can be based in Neuchatel, Zurich or Vienna.
The responsibilities will include:
• Support the delivery of product and maintain continuous supply of commercial product
• Define and implement plans for lifecycle initiatives for products
• Execute CMC strategy to support regulatory filings for product launch and to enable market expansion
• Implement plans to achieve post-marketing and regulatory commitments
• Support the enhancement of product and process knowledge and define and address process gaps through application of QbD best practices
• Provide adequate SME support of major process and methods investigations.
Main Activities :
Represents Technical Operations on commercial product governance teams. Ensures delivery of CMC-related goals and facilitates communication between teams and stakeholders.
Represents function to late stage Technical Operations Product Team. Responsible to develop strategy to enable overall product strategy and lifecycle initiatives and manage Supply Continuity, Risk Management, Line Extensions & Discontinuation, Launch Execution & Global Expansion/Contraction, COGs Management, Regulatory Activities, Product / Process Knowledge, and Capability & Improvement.
Leads Process Development and Technical Services Team throughout product lifecycle. Responsible to plan and execute product strategy and manage product lifecycle, including process and assay development, characterization, validation, technical transfer, CMC filing documents, and support stability and shelf life for products. Responsible to represent product to agencies.
Ensure technical rigor of team deliverables and provides broad drug development oversight to the team.
Drive rigorous assessment of issues and options.
Ensure appropriate approval/endorsement of team recommendations and work streams.
Drives consensus and timely decision making.
Responsible for communication of project status and risks to governance bodies, line management, functional areas, and sub-teams.
Create a high functioning PDTS subteam, holding team members accountable for performance, and mentoring/coaching as needed.
Education and Experience Requirements
Degree in Biochemistry, Protein Chemistry, Chemical Engineering or related disciplines with relevant experience in a biotechnology/pharmaceutical environment
Proven record of technical leadership
Proven record of cross-functional influence
Proven ability to work in a fast paced environment with demonstrated capacity to manage multiple tasks and demands
Direct drug development experience
Experience with application of risk-based approaches in decision making
Experience in risk identification and management
Experience in process development and characterization leading to definition of design space
Experience in development and implementation of process control strategy using QbD principles
The individual will be expected to:
Assess and provide feedback to cross-functional technical proposals and recommendations.
Identify and analyze complex technical problems and then find and implement solutions.
Apply fundamental scientific and biological principles to practical technical challenges.
Manage multiple work streams and projects. Make sound and timely decisions based on project priorities. Discern paths forward within ambiguous environments.
Provide expert input to departmental and senior management towards making strategic and functional decisions.
Become the product and process subject matter expert within Tech Ops and Regulatory CMC.
Ensure CMC strategy development delivers on the following:
Ensure and maintenance of continuous supply of commercial product
Ensure lifecycle initiatives for products are planned implemented
Ensure CMC strategy to support regulatory filings for product launch and to enable market expansion
Ensure plans and implementation to achieve post-marketing and regulatory commitments
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