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 QC-Microbiology Lead to join the Viralgen team!
About the role
We are seeking a QC-Microbiology Lead who will play a key role in the Quality Control Department within our Company.
The QC- Microbiology Lead will oversee and coordinate the Microbiology QC group and will plan and review all related operations of the group to achieve the strategic objectives of the company. The role will ensure adherence with regulatory and good practice requirements while feeling confident, showing experience, and demonstrating to have deep knowledge of the process and requirements of the department.
- Participate and lead in the continuous improvement of QC-Microbiology processes.
- Coordinate activities of the Micro Group.
- Develop and implement standard operating procedures (SOPs) and participate in their review/approval process.
- Oversee analytical work and review of analytical data. In particular, microbiological analysis techniques and raw materials testing (physicochemical techniques such as FTIR; HPLC, TOC).
- Resolution of formal investigations, deviations, incidents, OOS, etc.
- Responsible for the implementation, review, and approval of specifications and methods of analysis for raw materials and finished products.
- Supervise and oversight compliance of stability studies.
- Approval of analytical method validation protocols and supervision of their execution.
- Execution of the company's quality controls in the microbiology department, training, and staff development programs.
- Build and maintain strong cross functional relationships across the site, fostering a dynamic, communicative and respectful work culture within the team and between different departments.
- Bachelor’s Degree in Biology, Biochemistry, Biotechnology or equivalent; Advanced Degree preferred.
- Solid experience in leading teams.
- At least 2-3 years of experience in a QC-Microbiology role.
- Technical proficiency in the field of microbiology and aseptic practices.
- Pharma/biotech experience is preferable.
- Fluent in English and Spanish.
- Proactive with a positive attitude towards change and challenges.
- Self-motivated, who is used to work in a multidisciplinary 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.
- Good interpersonal skills including communication and self-management.