We are looking for an experienced Lab Manager (CRO) specializing in antibodies and CAR-T cell therapies to manage the laboratories and facility. In this role, you will manage R&D research services on antibody engendering, develop and production.
Description
- Lead and manage relationships with Business Development Manager for antibody and CAR-T cell therapy customers;
- Oversee trial execution, ensuring timelines, budgets, and quality metrics are met;
- Work closely with BD, R&D, clinical, market access and regulatory teams to align trial objectives with the customers needs and goals;
- Ensure compliance with INFARMED, FDA, EMA, and other global regulatory requirements;
- Manage vendor selection, contract negotiations, and performance evaluation of CRO partners.
Profile
- Bachelor's degree in Life Sciences, Immunology, Biotechnology, or a related field (Master's or PhD preferred).
- 5+ years of experience managing CROs in Biologics, Antibody or Cell Therapy Clinical Trials;
- In-depth knowledge of CAR-T cell therapies and antibody development processes.
- Experience in Laboratory management;
- Experience working with regulatory authorities like the FDA and EMA for the submission of clinical data and trial approvals;
- Experience in leading cross-functional teams and managing complex projects across multiple stakeholders;
- Excellent communication and interpersonal skills to work effectively with Academy, R&D, regulatory, medical, market access and operational teams;
- Strong project management, negotiation and communication skills.
Job Offer
Excellent opportunity to join an ambitious project, being part of a team that wants to revolutionize cancer treatment. Apply and help advance the next generation of therapies!