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 include a motivational cover letter (max 1 page)

Deadline 15th of February 2025

Preferred starting date: April 1st 2025 or sooner.