Head of Chemistry Manufacturing and Controls
vor 2 Wochen
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
-
Head of Technical Services
vor 1 Woche
Bern, Schweiz Johnson & Johnson Family of Companies VollzeitJanssen Vaccines, branch of Cilag GmbH International is recruiting for a Head of the Technical Services department, located in Bern, Switzerland: We develop and deliver innovative biopharmaceutical products based on bacterial and viral technologies. Our goal is to help people live happier and healthier lives. The Technical Services department plays a crucial...
-
Bern, Bern, Schweiz CSL Plasma Inc. VollzeitSenior Director and Site Head of Maintenance and UtilitiesApply locations EMEA, CH, Kanton Bern, Bern, CSL BehringTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: R-250153Join Our Team as Senior Director and Site Head of Maintenance and UtilitiesAre you a strategic leader with a passion for excellence in maintenance and utilities...
-
Bern, Schweiz CSL Plasma VollzeitJoin Our Team as Senior Director and Site Head of Maintenance and Utilities!Are you a strategic leader with a passion for excellence in maintenance and utilities management? We are looking for an experienced professional to join our team as the Site Head of Maintenance and Utilities, responsible for ensuring operational efficiency, safety, governance, and...
-
Bern, Bern, Schweiz CSL Plasma VollzeitJoin Our Team as Senior Director and Site Head of Maintenance and UtilitiesAre you a strategic leader with a passion for excellence in maintenance and utilities management? We are looking for an experienced professional to join our team as the Site Head of Maintenance and Utilities, responsible for ensuring operational efficiency, safety, governance, and...
-
Hr Business Partner And Head Of People
Vor 7 Tagen
Bern, Bern, Schweiz Bavarian Nordic Berna GmbH VollzeitWe are looking for an experienced HRBP and Head of P&O Switzerland, preferably with experience in the pharma industry, to support our Bern production site and head People & Organization in Switzerland.Your Role and ResponsibilitiesYou will play a dual role, supporting both the Bern Site Leadership Team and serving as the primary HR contact for Swiss...
-
Bern, Bern, Schweiz CSL Behring VollzeitAbout the OpportunityCSL Behring is a global leader in developing and delivering high-quality medicines for people with rare and serious diseases. We're seeking an experienced professional to join our team as Senior Director and Site Head of Maintenance and Utilities.Responsibilities:Team Leadership: Provide strong leadership to the Maintenance & Utilities...
-
Quality Control Technician
Vor 7 Tagen
Bern, Schweiz Insel Gruppe VollzeitSWAN Isotopen AG 100% | in Bern As soon as possible SWAN Isotopen AG is a fully certified modern radiopharmaceutical company based on the Campus of Inselspital, the University Hospital Bern. A team of 35 professionals is producing radiopharmaceuticals for diagnostic and for therapeutic purpose for nuclear medicine. To strengthen our Quality Control...
-
Head of Global Product Management
vor 4 Wochen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Head of Global Product Management (m/w/d), Bern DistrictClient:Albedis SALocation:Bern DistrictJob Category:OtherJob Reference:22500dbf78c3Job Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:In this dynamic role, you will be tasked with:Gather and analyze market and competitive intelligenceManage...
-
Head of Global Product Management
vor 4 Wochen
Bern, Schweiz TN Switzerland VollzeitHead of Global Product Management (m/w/d), BernClient:Albedis SALocation:BernJob Category:OtherJob Reference:22500dbf78c3Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:In this dynamic role, you will be tasked with:Gather and analyze market and competitive intelligenceManage product and segment growthSupport product launches and salesDrive...
-
Bern, Bern, Schweiz CSL Behring VollzeitAbout the RoleWe are seeking a seasoned professional to lead our Maintenance and Utilities teams as Senior Director and Site Head.Key Responsibilities:Strategic Leadership: Provide vision and direction to the team, fostering collaboration, accountability, and high performance.Safety Culture Champion: Drive a proactive safety culture, ensuring adherence to...
-
Manufacturing Specialist
vor 2 Wochen
Bern, Schweiz Discover International VollzeitTitle: Downstream ConsultantLength: 6 months with possibility of extensionKey Responsibilities:Collaborate with cross-functional teams to implement and integrate process improvements.Perform daily DSP (Downstream Processing) operations while providing technical expertise.Analyze and optimize manufacturing processes using advanced tools and...
-
Organic Chemistry and Admixture Research
vor 2 Wochen
Bern, Schweiz Coopers Group VollzeitFor our client in the greater Bern area we are looking for a **Organic Chemistry and Admixture Research (M/F/d)**: - Location Bern - Contract type permanent job - Workload: 100% **Your tasks**: - Propose and execute research plans for the development and production of novel polymers and chemicals in the field of Construction Chemicals - Prepare samples...
-
Manufacturing Specialist
vor 2 Wochen
Bern, Schweiz Discover International VollzeitTitle: Downstream ConsultantLength: 6 months with possibility of extensionWorkload: Full timeMode: on site 100% in SwitzerlandKey Responsibilities:Collaborate with cross-functional teams to implement and integrate process improvements.Perform daily DSP (Downstream Processing) operations while providing technical expertise.Analyze and optimize manufacturing...
-
Postdoc in Synthetic Radical Chemistry
vor 2 Wochen
Bern, Schweiz Universität Bern VollzeitA post-doc position is available for an on-going project on synthetic radical chemistry hosted by the University of Bern (Department of Chemistry and Biochemistry). Tasks The research involves the development of redox processes involving boron derivatives. The work will focus on the development of a broadly applicable method for the generation of...
-
Bern, Bern, Schweiz Oxford Global Resources VollzeitJob Description:Oxford Global Resources is seeking a skilled professional to join our team as a Process Specialist in biopharmaceutical manufacturing. In this role, you will be responsible for carrying out production activities in either upstream (USP) or downstream (DSP) processing.About the Role:Carry out daily manufacturing activities in USP or DSP,...
-
Head of Operations Medi24
vor 3 Wochen
Bern, Schweiz Allianz VollzeitHead of Operations Medi24 The Head of Operations, Medi24, is responsible for planning, directing and improving operational performance. In this role, you will directly lead the Customer Care, Telemedical and Medical teams, ensuring operational excellence and efficiency in meeting budget and customer service targets. Working with the Executive Board and the...
-
Head of Execution Systems, Emea
vor 2 Wochen
Bern, Schweiz CSL Behring Vollzeit**Purpose of the job**: Provide leadership to EMEA Execution Systems teams, you will be responsible for establishing, maintaining, and implementing standards-based approach for content, execution, and visualization of batch activities from lab to patient for both CAPEX and OPEX. **Principal Accountabilities**: - Responsible for leading a regional group...
-
Director of Engineering and Utilities Management
vor 21 Stunden
Bern, Bern, Schweiz CSL Behring VollzeitAbout the RoleWe're seeking a seasoned professional to join our team as Senior Director and Site Head of Maintenance and Utilities. As a key member of our leadership team, you'll be responsible for leading our Maintenance and Utilities teams, driving a proactive safety culture, and ensuring operational efficiency.Key Responsibilities:Strategic Leadership:...
-
Quality Control Specialist
Vor 4 Tagen
Bern, Bern, Schweiz Hobson Prior VollzeitWe are looking for a highly skilled Senior Scientist to join our team as a contract role in Bern, Switzerland. As a Senior Scientist, you will be responsible for supporting our project focused on updating computer systems within the quality control department.About the ProjectThis project involves working closely with various teams to ensure smooth...
-
Manufacturing Engineer
vor 4 Wochen
Bern, Schweiz ZipRecruiter VollzeitJob DescriptionPosition Summary:The primary purpose of this position is to coordinate and implement continuous improvement and lean manufacturing philosophies in the organization. This position will study manufacturing processes and implement improvements through design of new or improved manufacturing tooling and process changes. The position requires the...
