CMC-Lead / Team lead, NEOGAP Therapeutics

We want to cure cancer that until now could not be cured. Our company is in clinical phase and develops an individually adapted immunotherapy for the treatment of cancer using the patient's own cells. We are on an existing journey and need you as our new CMC-lead and team lead!

About the position

This role acts as Neogap`s lead for CMC and as team lead for today’s small production team of three persons. As CMC- lead you will be responsible for defining manufacturing practices and product specifications that must be followed and met to ensure product safety and consistency.

Our cell therapy is based on the company's two technologies: PIOR®, a software that uses DNA sequencing data from the patient and machine learning to select tumor-specific mutations. EpiTCer® is then used, a method to multiply the T cells that recognize the selected tumor-specific target structures.

Responsibilities and tasks:

• Manage and contribute to the daily operation in the lab related to development and GMP-production, from cell culture to released product in collaboration with the CMO.
• Coordinate the overall cell product development in collaboration with scientific lead and COO.
• Develop and oversee necessary documentation for clinical studies within the areas; process development, GMP-production, and development of analytical methods including potency assays.
• Guide regulatory interactions and act as main contact towards regulatory authorities in CMC related matters.
• Everyday communication with CMO, project management, scientific lead and company management team.

Neogap consists of a highly qualified team specializes in different parts of pre-clinical and clinical studies and management with a proven commercial background. We are a small agile company where collaboration between all functions is essential for success, which means assisting in the lab, contributing to the development of the QMS-system etc. Everyday we need to navigate in the ATMP landscape where development is made in a fast paste and answers to all questions a are not yet in place.

Your profile

We believe you are a scientifically driven person with confident to take responsibility for development and production of our ATMP product, from cell culture to product release. You have a desire to further develop the individuals in the team as well as drive development forward.

We are a company in start-up phase, so you need to feel at home in a dynamic environment where work tasks varies and where we support each other.

Qualifications and key experience:

• MSc and/or Phd or in immunology with competence and experience from cell culture and analysis or T-cells.
• Experience from project management, a team lead function or preferable from leadership positions.
• Industry experience in process development, validation, GMP-production within biologics/ATMP.
• Previous experience from CMC functions.
• An entrepreneurial mindset with a will to contribute to and join a small but ambitious.
• Excellent communication skills for internal and external contact. Fluent in English, preferably also in Swedish.

This position is a key role in Neogap Therapeuics journey going from research stage to helping cancer patients that until now could not be cured. It will be exiting, challenging and fun!

Interested?

In this recruitment, Neogap Therapeutics is collaborating with Mpya Sci & Tech.
Please submit your application no later than 20th of April. For any questions please do not hesitate to contact Sandra Bydell Sveder, Talent Advisor, +4670-8326148, sandra.sveder@mpyascitech.com.

About Neogap Therapeutics
Neogap Therapeutics is a biopharmaceutical company with the focus on immuno-oncology. The company was founded in 2016 by Dr. Hans Grönlund at Karolinska Institutet, Stockholm, and develops an individually adapted immunotherapy for the treatment of cancer using the patient's own cells. The therapy is based on the company's two technologies: PIOR®, a software that uses DNA sequencing data from the patient and machine learning to select tumor-specific mutations. EpiTCer® is then used, a method to multiply the T cells that recognize the selected tumor-specific target structures. NEOGAP is located at the Center for Molecular Medicine, Karolinska Institutet in Stockholm.

For more information about the technology please watch this movie, https://vimeo.com/613343841