Head of Chemistry Manufacturing and Controls

vor 7 Monaten

Bern, Schweiz CSL Behring Vollzeit

The Head of Chemistry Manufacturing and Controls (CMC) Strategy Office is responsible for two major functions:
1 - acting as a CMC Lead for one or more PPD CMC projects

2 - overseeing the CMC Strategy Office and Portfolio Management capabilities/resources within PPD.

Both elements require strong cross-functional and matrixed leadership capabilities, along with good interpersonal skills.

As CMC Lead, you 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).

As Strategy Office Lead, the position holder will be responsible for developing strategies to ensure that existing CMC sub-teams adopt innovative and robust CMC strategies to deliver safe, effective and high-quality products as fast as possible from bench to patients in need. The position holder will interact with industry and regulatory professionals to ensure that PPD CMC is adopting best-in-class CMC strategies and document packages. In addition, the position holder will oversee the Portfolio Management resource(s), which is the primary interface between PPD and external suppliers (CMOs, CDMOs, CROs) for plasma-related operations.

**Role and Responsibilities**

1. As CMC Strategy Lead, ensure high-performing CMC sub-teams (e.g., LCM, NPD, CMC Science) by interacting with industry (including CSL’s own cross-platform interaction with regulatory authorities) and regulatory experts, then consolidating and distributing knowledge to PPD CMC to ensure that methodologies are state-of-the-art.

2. As CMC Lead:

- Lead one or more CMC Delivery Teams (by project).
- Define and ensure execution of the phase appropriate process, analytical, and manufacturing programs (in close collaboration with R&D and operations).
- Ensure alignment on and communication of CMC strategies, objectives, and deliverables. Among other responsibilities, this includes regular reporting to Core Project Teams, Steering Committees and established governance bodies on progress against deliverables, timelines, and project risks and proactive leadership to reset priorities, request additional resources and make key decisions about directions for the CMC delivery teams.
- Maintain accountability for delivery of the Quality Section during clinical development, market authorization, and LCM changes for the CSL PPD projects including:

- Participate in the process scale-up and technology transfer activities within CSL Behring production sites;
- Contribute to the strategic aspects of product characterization, comparisons, manufacturing trending, trouble shooting and process changes, including a coordinated and well-structured dossier of reports;
- Maintain line-of-sight for all other aspects of the development process in Validation, QA, QC and Engineering, including ensuring a consistent and coordinated approach to their respective studies and reports;
- Maintain line-of-sight on all aspects of site manufacturing delivery (contracts, production, coordination, validation, regulatory activities).

3. As Head of Porfolio Management, provide strategic direction and oversight to the Portfolio Management team and liaise with similar functions in BPD (recombinant, gene therapy & vaccines CMC) to maximize CDMO/CRO relationships.

**Education and related past experiences**
- Ph.D., Masters, or BSc (or equivalent) in Biochemistry, Biology
- Minimum 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation.
- Demonstrated experience in project management and or leadership by influence preferred. Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred.
- Technical and regulatory writing experience.
- Previous experience working across sites and as part of international teams is highly desirable
- GRA/CMC Certifications favorable
- Fluency in English is a must.
- some knowledge of the German language is an asset

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Beh

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