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Cmc Lead Plasma Products Development
Vor 3 Tagen
We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.
Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for quality, ethics and discretion.
For our client, a renowned pharmaceutical company based in Bern, we are looking for an CMC Lead Plasma products development (M/F/d)
CMC Lead Plasma products development (M/F/d)
Background
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.
Tasks
This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for CSL 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, Manufacturing, and Quality.
This role will report to the Director LCM CMC PPD
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
- Oversight 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 CSL 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.
**Requirements**:
- \- Education: PhD or MSc in Biochemistry, Pharmacy, Chemical Engineering or related field.
- Experience: Minimum 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.
- Skills:
\- 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
\- Teamwork
\- Results orientation
\- Scientific/technical writing
\- Customer orientation
\- Planning and prioritization
\- Initiative
- Agility
\- Cross cultural sensitivity and flexibility
\- Data Gathering, Analysis, Problem solving, Integrity
Work hours
- 41 h / Standard
