Cell Therapy Compliance Manager
Vor 3 Tagen
About the Role:
As a key member of our team, you will be responsible for ensuring the quality oversight of Cell and Gene Therapy products across all platforms and domains. This includes ensuring compliance with EMA, FDA, and other relevant regulations. You will provide CMC and QA expertise to CGT companies to prepare INDs, IMPDs, and BLAs for various markets.
Key Responsibilities:
- Provide CMC and QA expertise for CGT companies, ensuring preparation of regulatory documents;
- Act as the key QA expert and contact for Regulatory Affairs in CGT companies;
- Support Quality Compliance oversight for CGT products throughout clinical and commercial phases;
- Ensure QA compliance of regulatory documentation with EMA, FDA, and other regulations;
- Contribute to regulatory strategy and establish control strategies across CGT;
- Facilitate cross-functional regulatory support to expedite product submissions;
- Develop strategies for efficient development and commercialization in collaboration with RA functions;
- Support the establishment of CGT QMS & Compliance;
- Promote knowledge exchange and best practices across CGT satellites and Bayer functions;
- Serve as the Regulatory CMC interface for CGT products.
Requirements:
- PhD/MD in Biotechnology, Virology, Cell Engineering, Pharmaceutical Technology, or related field;
- 15 years of experience in the pharmaceutical industry;
- Strong understanding and hands-on experience with molecular biology methods;
- Required experience in a cGMP environment and writing regulatory documents for CGT products;
- Deep understanding of quality requirements for gene and cell therapy products;
- Exposure to diverse modalities in gene and cell therapies;
- Experience in GMP/GCP inspections for CGT products;
- Ability to implement systems and troubleshoot critical issues;
- Driven by creating value for the customer (patient);
- Fluent in English, with negotiation skills at the C level. Fluency in German will be a plus.
-
Cell and Gene Therapy Regulatory Affairs Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitRegulatory Affairs OpportunityBayer CropScience Limited is seeking a Cell and Gene Therapy Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with EMA, FDA, and other relevant regulations.ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring...
-
Cell and Gene Therapy CMC Compliance Head
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Cell and Gene Therapy CMC Compliance Head
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Bayer AG VollzeitAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities,...
-
Cell Therapy Research Lead
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitYour ProfileEducation:PhD in Immunology, Cellular Biology, or a related field with postdoctoral experience preferred.Experience:Proven track record in T cell therapy research and development;Extensive hands-on experience in immune cell assays and multicolor flow cytometry;Proficiency in CRISPR/Cas9 and library design;Genomics and/or transcriptomics data...
-
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitJob OverviewThis is an exciting opportunity to join our Pharmaceuticals division as a Senior Regulatory CMC Specialist in Cell and Gene Therapy. You will play a key role in ensuring compliance with regulatory requirements and providing expertise to CGT companies.Duties and ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring preparation of...
-
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitJob DescriptionWe are seeking a Global Cell and Gene Therapy Quality Assurance Expert to join our team. This is a unique opportunity to work on complex regulatory projects and contribute to the growth of our business.Main ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring preparation of INDs and BLAs;Act as the key QA expert and contact...
-
CMC Compliance Head for Cell and Gene Therapies
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitAbout the RoleBayer CropScience Limited is seeking a highly skilled Cell and Gene Therapy CMC Compliance Head to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with EMA, FDA, and other relevant regulations.Key ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring...
-
Basel, Basel-Stadt, Schweiz Roche VollzeitThe Position Orchestration and Exception Management (O&EM) is a new and fundamental capability for Technical Operations (PT) in order to deliver a future portfolio of Cell & Gene Therapy products. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges: living...
-
Regulatory Expert in Cell and Gene Medicine
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Bayer AG VollzeitAbout Bayer AG:We are a leading life science company with a strong commitment to innovation and customer satisfaction. Our mission is to improve human life through science and technology.Job Overview:This role is part of our Cell and Gene Therapy team, which focuses on developing innovative treatments for patients worldwide.Key Responsibilities:Work closely...
-
Cell Culture Automation Engineer
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Institute of Human Biology VollzeitJob DescriptionThe Cell Culture Automation Engineer will play a critical role in the development and optimization of advanced in vitro culture protocols on a plate-based automation platform at the Institute of Human Biology.The ideal candidate will have extensive experience in automation for biological systems, preferably with liquid handling platforms...
-
Senior Scientist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Karlstad University VollzeitSenior Scientist (T Cell Therapy Development)The University of Basel ranks among the world's one hundred best universities and boasts a top-ten place among German-speaking universities.The Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical scientists to advance our...
-
Senior Scientist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitSenior Scientist (T Cell Therapy Development) The Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical scientists to advance our understanding of health and disease and to develop pioneering therapies benefiting the lives of patients in areas of unmet need. With more...
-
Industry Compliance Manager
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Huntsman VollzeitWhat We Are Looking ForWe are seeking an Industry Compliance Manager to support internal and external audits to ensure adherence to automotive standards. You will engage with customers and suppliers to align quality expectations and requirements, conduct gap analysis to identify discrepancies between current practices and automotive standards, and develop...
-
Career Advancement through Operations
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Roche VollzeitThe OpportunityThis is an exciting opportunity to join Roche's Pharma Technical Operations (PT) team as a rotational development trainee. You'll have the chance to gain hands-on experience in different areas of PT, including internal manufacturing network, quality and compliance, cell & gene therapy, technical development, operational excellence & digital,...
-
Senior Scientist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz myScience VollzeitSenior Scientist (T Cell Therapy Development)University of BaselPublished 5 March 2025Workplace Basel, North West Switzerland, SwitzerlandCategory HealthLife SciencesPosition Regular Employment / CollaboratorThe Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical...
-
Senior Scientist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitThe Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical scientists to advance our understanding of health and disease and to develop pioneering therapies benefiting the lives of patients in areas of unmet need. With more than 70 research groups and 800 employees, the...
-
Senior Scientist
vor 1 Tag
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitThe Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical scientists to advance our understanding of health and disease and to develop pioneering therapies benefiting the lives of patients in areas of unmet need. With more than 70 research groups and 800 employees, the...
-
Senior Scientist
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitThe Department of Biomedicine is a joint effort between the University of Basel and the University Hospitals Basel. It unites basic and clinical scientists to advance our understanding of health and disease and to develop pioneering therapies benefiting the lives of patients in areas of unmet need. With more than 70 research groups and 800 employees, the...
-
Process Excellence Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Overview:The Process Excellence Manager - Regulatory Compliance will play a critical role in driving process improvements and enhancing compliance across our regulatory affairs function. This individual will lead initiatives to streamline processes, eliminate inefficiencies, and ensure adherence to regulatory requirements.About the Position:Leverage data...
-
Immunology Expertise Required
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz Universität Basel VollzeitRequired Skills and QualificationsDesign, optimize, and implement strategies for developing T cell-based therapeutic products;Lead preclinical studies to evaluate T cell function, persistence, and efficacy;Develop and execute multicolor flow cytometry panels to assess immune cell phenotypes and functions;Design and perform immune assays, including cytokine...