CMC Development Manager
3 days ago
About Loma Therapeutics
">Loma Therapeutics is a pre-clinical stage biotech startup focused on developing an HPV-targeted immunotherapy. The company aims to initiate clinical trials in the near future, with the current priority being the CMC development of its lead medicinal product.
">Job Overview
">This role will be responsible for overseeing the company's CMC-related activities, primarily at a contract manufacturing organization (CDMO). As the main point of contact, you will ensure a smooth and efficient collaboration, prioritizing quality and adherence to timelines.
">The successful candidate will work closely with the CDMO, ensuring adherence to GMP standards and troubleshooting any production issues that may arise. Additionally, they will be involved in regulatory interactions and responsible for CMC-related aspects.
">Main Responsibilities
">- ">
- Coordinating and managing CMC development and GMP manufacturing at the CDMO">
- Ensuring smooth and timely collaboration">
- Overseeing scale-up">
- Ensuring quality requirements and production consistency">
- Validation and documentation of manufacturing processes and analytical methods">
- Analysing and interpreting data from the CDMO to maximize quality, yield, and stability">
- Communicating updates and concerns to the Loma team">
- Preparing, reviewing, and updating regulatory submission documents">
- Coodinating and collaborating with the R&D team">
Requirements
">The ideal candidate should possess:
">- ">
- A MSc degree and 3 years of experience as a CMC leader">
- Experience from a CDMO or collaborating with CDMOs">
- Deep understanding of CMC requirements for clinical trials">
- Experience with manufacturing of viral vectors is an advantage">
- Ability to work independently and as part of a small team">
- Fluent English">
- Experience from early-stage biotech is an advantage">
Benefits
">We offer a challenging and dynamic environment with opportunities for growth and professional development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
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