Fill & Finish Lead
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 Fill & Finish Lead to join the Viralgen team!
About the role
We are seeking a Fill and Finish (FF) Lead who will play a key role on the structure of the company in production.
The job involves organizing and supervising the proper performance of FF team with the assistance of the Manufacturing Head.
- To be responsible for the final filling stage of the production process, as well as the control of the facilities according to GMP standards.
- Ensure the products comply with the required quality.
- Approve instructions relating to the production operations of the Final Filling stages and ensure strict compliance.
- Ensure production records are completed following cGMP and according to internal company standards.
- Ensure the qualification and maintenance of your department, premises and equipment.
- Ensure that the Fill and Finish team is properly trained and fit for purpose.
- Participate in multi-disciplinary validation teams by being the voice of Fill and Finish in these teams.
- Pharmacist, Chemical Engineer, Chemist, Biologist or similar University Degree.
- Solid experience of 2-3 years in this sector with similar responsibilities.
- Solid experience leading teams of 5 people or more.
- Technical proficiency in the field of sterile filling (vials, syringes), mediafill executions, clean rooms operation and sterile filling process validation.
- AAVs purification experience is highly desired.
- Knowledge in unicorn software is desirable.
- Experience in tech transfer, scale-up and working with very low volumes is desirable.
- Fluent in English and Spanish.
- 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.
- Demonstrated passion for producing high-quality work.
- Proactive management and positive attitude to change and challenges.
- Communication skills and self-management.