CMC Lead – Plasma Product Development – 5378 URA
Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.
This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for plasma product development (PPD) projects. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM).
To accomplish these objectives, the CMC Lead will provide strategic direction, technical expertise, coordination and oversight of cross-functional, global and local CMC teams including representatives from Process Development, Analytical Development, Global Pathogen Safety, Technology Transfer, Quality, Regulatory Affairs, Validation and Manufacturing. This role is initially a 24 months contract opportunity with chances of becoming internal role to be based in Bern area.
· Work in close collaboration with R&D and operations, defines and ensures execution of the phase appropriate process, analytical, and manufacturing programs:
· For Life Cycle Management (LCM) projects, defines manufacturing operation development targets
· Ooversights of process scale-up and transfer activities
· Responsible ensuring process/product characterization and comparability after process changes
· Accountable for development of process control strategy including leading development of product specifications in a cross-functional team.
· Ensures alignment on and communication of CMC strategies, objectives, and deliverables.
· Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes for the PPD projects.
· Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, Process Control Strategies, in accordance with global CMC/QbD policies.
· Executes globalization/ harmonization initiatives across sites that drive efficiencies, establishes best practices, and return values to CSL Behring.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
· PhD or MSc in Biochemistry, Pharmacy, Chemical Engineering or related field.
· At least 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation. Demonstrated experience in project leadership by influence. Advanced knowledge of biological manufacturing processes and advanced, state of the art CMC/QbD requirements for plasma derived or biotechnology therapies.
· Technical and regulatory writing experience. Previous experience working across sites and as part of international teams is highly desirable.
· Patient safety strategies and GMP related aspects to ensure safety and efficacy of biological products
· Biologics process development and validation
· Advanced Quality by Design
· Superb leadership in a matrix organisation. Teamwork, Results orientation, Customer orientation, Planning and prioritization, Initiative, Agility, Cross cultural sensitivity, flexibility
Data Gathering, Analysis, Problem solving and integrity.
· Scientific technical writing experience is good to have.