Principal Scientist with drug substance knowledge for development projects
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Hørsholm
Gubra is looking for an experienced Principal Scientist with CMC project manager skills, preferably combined with strong drug substance knowledge to fill a newly established position in our growing drug development department.
The development department consists of a cross-functional team that covers CMC-, nonclinical- and clinical-development, where you will report to the department manager. In addition, we work with external consultants, CDMOs and CROs in a hybrid format to progress our projects. Our ambition is to expand an already strong discovery pipeline with clinical testing in humans within multiple disease areas. As part of our small team, you will be able to influence and shape your job content in collaboration with the other members of the department.
As our new colleague, you will primarily focus on establishing and driving collaborations with CDMOs, supporting one or more clinical trials with API peptide manufacture and drive the delivery of accompanying documentation. In addition, you will work closely together with our formulation specialist during development and manufacture of drug products for early phase trials.
Your main responsibilities
Professional qualifications
As a person you can navigate and collaborate in an energetic and dynamic organization. You are self-motivated and keen on setting and delivering to deadlines. You can build trust and consensus across professional and geographical boundaries. Finally, you are 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 no later than March 10th 2024, by uploading your motivated cover letter, resumé and relevant diplomas on our website. Please apply as soon as possible and note that applications will be reviewed on an ongoing basis. If you have questions about the position, please contact Project Director, Stine Jørgensen at [email protected].
About Gubra
Gubrais an ambitious CRO & Biotech company 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 fight for 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.
We have two primary areas of business: Preclinical contract research (CRO) services, as well as peptide drug discovery partnerships. 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 +200 employees all located in Hørsholm, Denmark. 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 drive, scientific curiosity, and teamwork – we join forces!
The development department consists of a cross-functional team that covers CMC-, nonclinical- and clinical-development, where you will report to the department manager. In addition, we work with external consultants, CDMOs and CROs in a hybrid format to progress our projects. Our ambition is to expand an already strong discovery pipeline with clinical testing in humans within multiple disease areas. As part of our small team, you will be able to influence and shape your job content in collaboration with the other members of the department.
As our new colleague, you will primarily focus on establishing and driving collaborations with CDMOs, supporting one or more clinical trials with API peptide manufacture and drive the delivery of accompanying documentation. In addition, you will work closely together with our formulation specialist during development and manufacture of drug products for early phase trials.
Your main responsibilities
- Oversee tech transfer and API peptide manufacturing at CDMOs
- Manage timelines and deliverables in existing and 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
- Manage contracts with external collaborators
- Contribute to Gubra´s QMS system
Professional qualifications
- PhD degree in chemistry, engineering, pharmacy or similar, with a minimum of 5 years' of relevant experience from industry
- Extensive experience from peptide projects in early clinical development
- Proven collaboration and stakeholder management skills
- Thorough understanding of GMP, regulatory requirements and relevant guidelines for API manufacturing
As a person you can navigate and collaborate in an energetic and dynamic organization. You are self-motivated and keen on setting and delivering to deadlines. You can build trust and consensus across professional and geographical boundaries. Finally, you are 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 no later than March 10th 2024, by uploading your motivated cover letter, resumé and relevant diplomas on our website. Please apply as soon as possible and note that applications will be reviewed on an ongoing basis. If you have questions about the position, please contact Project Director, Stine Jørgensen at [email protected].
About Gubra
Gubrais an ambitious CRO & Biotech company 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 fight for 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.
We have two primary areas of business: Preclinical contract research (CRO) services, as well as peptide drug discovery partnerships. 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 +200 employees all located in Hørsholm, Denmark. 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 drive, scientific curiosity, and teamwork – we join forces!
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 20.2.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Hørsholm
- Søndag den 10. marts 2024
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