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Group Leader - Cell and Gene Therapy (Quality Control)
Position: Group Leader - Cell and Gene Therapy (Quality Control)
Desired Profile: Ph.D. (specialization Immunology and Virology/Microbiology) with 8+ years of experience in academia and industry
Job Description, Key Skills and Competencies:
- The candidate should have experience in development and validation of cell and gene therapy products. Prior experience working in a cGMP setting will be preferred.
- He/she will be expected to have worked with primary cells and cell lines in immunology or immuno-oncology context.
- The candidate needs must be well-versed in cell-based assay development, flow cytometry, sorting, real-time PCR, and microbiological assays.
- The candidate should be proficient in verbal, written and presentation skills
- The candidate should have had experience in managing a team, interacting with clients/collaborators, and working across functions
- In the current role, the candidate will have to support cellular therapy quality control studies which will encompass cell biology, molecular biology, and microbiological processes.
- The candidate needs to have leadership skills to gear a team towards excellence. Manage day to day activity of team members providing critical technical/scientific recommendations with effective trouble-shooting and innovative capabilities.
- The candidate should be able to effectively communicate and work closely in a highly matrixed team environment to advance company’s cell therapy pipeline.
- The candidate should be able to closely coordinate with internal functions like manufacturing, quality assurance, clinical development, supply chain management as well as with external collaborators for development of a product.
- The candidate needs to show active participation and readiness to assist support functions in setting up and validation of a GMP facility.
- The candidate will be expected to exhibit strict adherence to project timelines while preserving integrity, accuracy, safety, and quality.
- The candidate will be expected to understand systems and processes pertaining to sterile practices, work ethics, safety, health, and environment.
- The candidate will have to be involved in preparation and participation during compliance monitoring inspections and regulatory agency interactions.
- The candidate must be involved in preparation and review of SOPs, protocols, reports, regulatory documents, pertaining to program requirement.
- Immunology and Immuno-oncology assay design and development
- Microbiological processes for product validation
- Presentation & Communication Skills
- Team Management
- Interpersonal Skills
- Stakeholder Management
- Vendor Management