Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.
We are excited for our next MSAT Scientist to join the Viralgen team!
About the role
We are seeking a MSAT Scientist who will play a key role on the structure of the company.
The job involves supporting different activities related and within the manufacturing process department at the new Viralgen Commercial facility with the assistance of the MSAT Head.
- Responsible for the tech transfer activities.
- Ensure a proper transfer of new processes for the new Viralgen Commercial facility.
- Perform scale-up designs of the processes transferred from pilot scales to Viralgen Commercial facility.
- Collaborate with the USP and DSP teams of the pilot platforms to ensure a proper performance of the processes at Viralgen Commercial.
- Define the control strategy of the commercial processes considering the historical manufacturing results of products manufactured at Viralgen Commercial Therapeutic and following a risk assessment approach.
- Evaluate and verify the status of the commercial process applying statistical and data analysis tools.
- Evaluate the impact of deviations on product quality, change controls, out of specifications and any other incidence related with the products manufactured at the Commercial Plant.
- Elaborate technical reports required for the different products.
- Bachelor’s degree in Engineering Sciences, Biotechnology, Health Sciences or equivalent.
- 2-3 years of demonstrated experience in a biopharmaceutical company with similar responsibilities.
- Technical proficiency in the scale-ups and manufacturing processes designs.
- Understanding of GMP regulations.
- Communication skills and self-management.
- Fluent in English and Spanish or equivalent.
- Ability to multi-task and meet deadlines in a fast-paced environment.
- Demonstrated ability to work both independently and in a team environment.
- Demonstrated ability to work well under pressure and meet tight deadlines.
- Proactive management and positive attitude to change and challenges.