Vyriad is a clinical stage biotechnology company focused on curing cancer using potent, safe and cost effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery and fun.
The Bioproduction Technologist will be responsible for manufacturing of Vyriad’s oncolytic viruses and other biologics for clinical trials, as well as preclinical process development. The Bioproduction Technologist plays a vital role in the day-to-day manufacturing operations in compliance with cGMP standards. Bioproduction involves aseptic processing in a pharmaceutical cleanroom facility, large-scale cell culture, vector generation, purification, concentration, and fill and finish operations, according to established standard operating procedures (SOPs). In addition, staff are responsible for the daily operations and environmental monitoring of the GMP facility to ensure compliance with applicable regulations.
- Performs all aspects of cGMP manufacturing of clinical grade viruses and viral vectors following established SOPs.
- Performs preclinical grade viral vector production, scale-up and process development.
- Reviews, edits, completes, and revises batch records, worksheets, and SOPs in accordance with Good Document practices.
- Prepares reagents and ensures inventory for the manufacture of clinical and preclinical viral vectors.
- Performs set up, dismantling, and maintenance of equipment and ensures equipment is ready for production operations.
- Performs manufacturing level maintenance on equipment.
- Participates in equipment installation, commissioning, and validation.
- Maintains manufacturing equipment and records.
- Participates in quality control testing of clinical and preclinical grade vectors.
- Assists with facility cleaning, changeover, and staging of materials.
- Collaborates closely with the Process Development, Quality Control and Quality Assurance teams.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Provides technical representation during internal and external audits.
- Keeps up to date with current technologies and trends in drug product processing.
- Performs routine tasks including general housekeeping, equipment monitoring and maintenance.
- Bachelor’s degree in Biomedical, Chemical Engineering or Life Sciences with 3 years relevant experience in biomanufacturing or research environment.
- Experience with upstream and/or downstream manufacture of biologics under cGMP compliance is highly desirable.
Experience and skill requirement
- Prior laboratory experience in research and aseptic cell culture techniques desirable.
- Viral vector production experience highly desirable.
- Ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
- Excellent documentation skills including comprehension, review and establishing Batch Production Records, SOPs, deviations, and summary reports.
Relevant: Research or analytical. Experience with cGMP production highly desirable.
Rochester, MN (Required)
United States (Required)
How to apply
To apply please send a resume and cover letter to email@example.com. References will be requested and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Vyriad is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.