About Loma Therapeutics

Loma Therapeutics is a pre-clinical stage biotech startup developing an HPV-targeted immunotherapy. Every year, 800,000 new HPV-related cancers are diagnosed, but existing treatments do not directly target the causative HPV infection. In Loma Therapeutics, we aim to develop a best-in-class treatment to improve treatment options and patient outcomes for HPV-infected patients. Loma Therapeutics is at the pre-clinical stage, with the aim of starting clinical trials in a few years. We are primarily working with adenoviral vectors, but the work may also include other nucleotide-based modalities (other viral vector platforms, mRNA, etc.). Loma Therapeutics has selected our lead drug candidate, consisting of two adenoviral vectors, and 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). These CMC development tasks (conducted at the CDMO) includes upstream and downstream process development at pilot scale, upscaling, development of analytical methods, and stability studies, ultimately leading towards GMP manufacturing and release of the GMP product for clinical studies. 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, and communicating any concerns related to the CMC process to the rest of the Loma team as soon as possible, so we can solve the problems and take relevant mitigating actions together.

As Loma Therapeutics is working towards clinical trials, we will have regulatory interactions, and the CMC Manager will be involved in this, and responsible for the CMC-related aspects of the regulatory area, together with our regulatory consultants.

Due to the many stakeholders (CDMO, the Loma internal team, consultants, regulatory bodies, etc.), it is important that the CMC Manager is ready to work in a team-oriented manner, with good communication and collaboration as a priority.

In Loma Therapeutics we strive to create an environment that allows for open and honest communication, and generally, our goal is to operate within a flat organizational structure, fostering an environment where every team member contributes to shaping the company's direction. The CMC development will be a pivotal part of the company’s development, and thus the CMC Manager will play a key role in advancing the company and our HPV-targeting therapy.

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 the scale-up of manufacturing processes from pilot to full-scale production with a focus on quality and timelines

- Ensure that the manufacturing processes meet the quality requirements, and that the product is consistently produced and controlled according to quality standards and regulatory requirements

- Validation and documentation of manufacturing processes and analytical methods

- Establish and oversee stability studies

- Analysis and interpretation of data from the CDMO, and take relevant actions to maximize quality, yield, and stability of the product

- Communicating updates and concerns to the internal Loma team in an open and up-front manner, and drive any internal processes related to challenges with the CMC development

Other CMC-related activities

- Engage in regulatory interactions (e.g. scientific advice) and prepare, review, and update regulatory submission documents (e.g. clinical trial application) to ensure compliance with regulatory standards

- Coordinate and collaborate with the R&D team on evaluating potential future modalities (e.g. mRNA or other viral vectors or formulations)

- Providing CMC-related training and guidance to internal team members and external partners/vendors

- Provide input on CMC development for VC fundraising and funding applications

- Responsible for the CMC budget

Strategic planning and business development

- Identifying and implementing improvements in CMC-related procedures and processes to enhance efficiency and maintain compliance with evolving regulatory landscapes

- Review all manufacturing and clinical materials to ensure the CMC aspects are appropriately represented

- Provide input on CMC development in strategic discussions with team, executive management, board of directors, and scientific advisors

- Provide input on feasibility, possibilities, and priorities for CMC activities

The ideal candidate has the following qualifications

- A master’s degree and at least 3 years of experience as a CMC leader with early CMC development and initial GMP manufacturing

- 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

- Presence in the Copenhagen office for most of the work hours will be preferred

- Strong communication and collaboration skills. The CMC area is a critical path for Loma’s development, so transparent and early communication about challenges is crucial. Working language is English and fluency is a requirement

- High degree of responsibility and accountability

- Well organized and thorough

- Experience from early-stage biotech (pre-clinical stage or early clinical stage) is an advantage

- Experience with regulatory interactions is an advantage

- Experience with managing a budget 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

- Close collaboration with the executive management team on priorities, strategy, and planning of the CMC activities

- A workplace with a small but dedicated team who focuses on supporting each other and lifting together, and where a healthy work-life balance and personal development are high priorities

Questions

For further information about Loma Therapeutics and the position, please contact Stephanie Holstein-Rønsbo (42 33 73 93, stephanie@lomatherapeutics.com).

Application

The application must be submitted in English and must include the following documents:

- Cover letter, including motivation for applying for the position (maximum 1 page)

- Curriculum vitae, including a list of key publications

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 1^st 2025 or sooner.

Loma Therapeutics

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