Gubra is looking for an experienced Drug Substance Specialist, to fill a newly established position in our small but growing CMC department.
As our new colleague and first Drug Substance CMC expert, you will primarily focus on establishing and driving collaborations with CDMOs, supporting early phase clinical trials and non-clinical tox studies with outsourcing peptide manufacture, manufacturing process development, and ensure the delivery of accompanying documentation.
We have a bold ambition to further expand our clinical pipeline within multiple disease areas. As part of the team, you will be able to influence and shape your job content in collaboration with your colleagues. You will work closely with the rest of the CMC team and the other departments in the area led by our Chief Medical and Development Officer, but also with the other departments in our Biotech business unit, in a friendly and helpful atmosphere, where we obtain ambitious results together.
Your main responsibilities
- Overall responsibility for Drug Substance tech transfer and process development at CDMOs
- Manage existing and establish new collaborations with CDMOs
- Drive operational deliverables in alignment with project goals
- Ensure compliant documentation for regulatory submissions
- Identify and qualify new vendors as required, including SME support to quality audits
Professional qualifications
- PhD degree in chemistry, biochemistry, engineering or similar, with a minimum of 5 years of relevant experience from biotech or pharma
- Extensive experience from peptide projects in early clinical development, including outsourcing to CDMOs
- Strong collaboration, communication and stakeholder management skills
- Thorough understanding of GMP, regulatory requirements and relevant guidelines for API manufacturing
- Experience in due diligence processes and collaboration with external partners is beneficial
As a person you are flexible, can navigate and collaborate in an energetic and dynamic organization. You are proactive, self-motivated and keen on setting and delivering to deadlines.
You can build trust across professional and geographical boundaries; you are an excellent communicator and a team player that sees the value in reaching ambitious goals via a joint effort with the opportunity to grow along the way.
Application details
Please apply as soon as possible and no later than March 1st, by uploading your motivated cover letter, resumé and relevant diplomas on our website. If you have questions about the position, please contact Senior CMC Project Manager Francesca Macchi, fma@gubra.dk.
About Gubra
Gubra is a disease-agnostic techbio company specialized in peptide-based drug discovery and preclinical contract research services striving for excellence at all levels. We insist on doing things efficiently – and often differently - to reach the results we aim for. Our vision is to become leaders in the path towards a more sustainable and healthier world. We do that by facilitating the discovery of new medicine, and by acting and inspiring others to fight the ongoing climate and biodiversity crises.
Gubra’s activities are focused on the early stages of drug development and are organised in two main highly synergistic business areas: Biotech and CRO Services. We generate our revenue by performing research for life science companies as well as by partnering projects from our discovery and development pipeline.
Our therapeutic focus is within metabolic and fibrotic diseases, and we specialize in in vivo pharmacology, ex vivo assays, drug profiling, histology, stereology and whole brain and organ imaging. In addition, we offer a full palette of advanced transcriptomics. Our ML/AI-driven peptide drug discovery platform streaMLine enables us to rapidly develop a peptide hit into a non-clinical candidate ready for development. Through a constant focus on high quality, scientific excellence, speed, and solid teamwork we have established ourselves as a highly professional and competent partner in the market.
People are our greatest asset, and our team consists of around 300 employees. The mix of people from different cultures and educational backgrounds combined with our entrepreneurial mindset have greatly impacted our working environment, which is characterized by entrepreneurial drive, scientific curiosity, and teamwork – we join forces!
