About Loma Therapeutics
Loma Therapeutics is a pre-clinical stage biotech startup developing an HPV-targeted immunotherapy. Loma Therapeutics is at the pre-clinical stage, with the aim of starting clinical trials in a few years. Loma Therapeutics is currently initiating the CMC development.
Job Overview
- You will be the main responsible for the company's CMC-related activities, primarily the development of our lead medicinal product at a contract manufacturing organization (CDMO).
- You will be the main point of contact with the CDMO and be responsible for ensuring a smooth and efficient collaboration with a strong focus on quality and adherence to timelines.
- The CMC Manager will also be responsible for ensuring adherence to GMP, of troubleshooting any production issues that may occur.
- The CMC Manager will be involved in regulatory interactions and will be responsible for the CMC-related aspects.
- It is important that the CMC Manager is ready to work in a team-oriented manner, with good communication and collaboration as a priority.
- The position is part-time (approximately 20 hours/week).
Key Responsibilities
- Coordinating and managing the 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
- Analyse and interpret data from the CDMO to maximize quality, yield, and stability
- Communicating updates and concerns to the Loma team
Other CMC-related activities
- Prepare, review, and update regulatory submission documents (e.g. CTA)
- Coordinate and collaborate with the R&D team
The ideal candidate has the following qualifications
- MSc degree and 3 years of experience as a CMC leader
- Experience from a CDMO or collaborating with CDMOs
- Deep understanding of the CMC requirements for clinical trials
- Experience with manufacturing of viral vectors is an advantage
- Ability to work in Copenhagen
- Fluent English
- Experience from early-stage biotech is an advantage
In a newly established biotech company, you will be part of a high-paced and exciting journey towards developing a novel targeted immunotherapy for patients with HPV cancer and pre-cancer. This endeavor demands an open-minded, team-oriented approach, and a readiness to tackle a diverse array of tasks. In addition to the CMC activities that you will be spearheading, you will be a part of discussions on clinical and R&D strategy.
We offer
- A part-time position of appr. 20 hours/week. Hours may vary according to workload.
- A high level of independence and responsibility
- A workplace with a small but dedicated team
Questions
For further information, please contact Stephanie Holstein-Rønsbo (+45 42 33 73 93, stephanie@lomatherapeutics.com).
Application
The application must be submitted in English and must include the following documents:
- Curriculum vitae, including a list of key publications
- Please send a motivational cover letter by email (max 1 page)
Application deadline 15th of February 2025, however, applicants will be interviewed on an ongoing basis, and we encourage everyone to apply as soon as possible, as we may complete the hiring process before the application deadline.
Preferred starting date: April 1st 2025 or sooner.
