POSITION OPENING
GMP Expert – Oncolytic Virus Production
Location: San Francisco Bay area
Company: Alpha OV Therapeutics Inc.
Job Type: Full-Time
Department: Manufacturing & Production
About Alpha OV Therapeutics:
Alpha OV Therapeutics is at the forefront of developing innovative oncolytic viral therapies that target and destroy cancer cells while activating the immune system to fight tumors more effectively. We are dedicated to transforming cancer treatment through cutting-edge viral technology, and we are now seeking a GMP Expert to join our team to lead the production of GMP-grade oncolytic viruses for clinical applications.
Position Overview:
The GMP Expert will play a critical role in overseeing and managing the production of oncolytic viruses under Good Manufacturing Practice (GMP) conditions. This position is responsible for ensuring that the viral products meet the highest quality standards required for clinical trials and future commercialization. The ideal candidate will have a deep understanding of GMP guidelines, experience in viral vector production, and the ability to collaborate across departments to ensure seamless, compliant manufacturing processes.
Key Responsibilities:
- Oversee the production of GMP-grade oncolytic viruses for preclinical and clinical use.
- Develop, implement, and manage GMP-compliant processes and protocols for viral production.
- Ensure strict adherence to regulatory guidelines (FDA, EMA, etc.) and quality standards.
- Collaborate with Research & Development and Quality Assurance teams to scale up production while maintaining GMP compliance.
- Manage and monitor the production environment, including clean room facilities, equipment, and personnel to ensure consistent GMP standards.
- Lead the validation and qualification of equipment and processes used in the production of oncolytic viruses.
- Prepare and maintain detailed documentation, including batch records, Standard Operating Procedures (SOPs), and production reports.
- Identify and troubleshoot manufacturing issues to ensure smooth production flow.
- Stay current on regulatory changes and emerging technologies to improve the manufacturing process.
- Train and mentor junior team members on GMP practices and procedures.
Qualifications:
- Bachelor’s, Master’s, or Ph.D. in Biotechnology, Biochemistry, or a related field.
- 5+ years of experience in GMP-compliant manufacturing, preferably in viral vector production or biologics.
- Extensive knowledge of GMP regulations and industry standards (e.g., ICH, FDA, EMA).
- Proven experience in scaling up viral production for clinical use.
- Strong understanding of bioreactor systems, viral purification processes, and aseptic techniques.
- Familiarity with clean room operations and environmental monitoring.
- Excellent problem-solving skills with attention to detail.
- Strong communication and leadership skills, with experience working in cross-functional teams.
- Ability to manage multiple projects simultaneously in a fast-paced environment.
Preferred Skills:
- Experience with oncolytic virus or gene therapy production.
- Previous experience working in early-stage biopharmaceutical companies.
- Hands-on experience with viral purification methods such as chromatography and filtration.
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work on cutting-edge cancer therapies with a growing, dynamic team.
- Access to state-of-the-art facilities and technologies.
- The chance to make a significant impact in the fight against cancer.
How to Apply:
Please submit your resume and cover letter detailing your qualifications and experience to career@alphaovtherapeutics.com. We look forward to welcoming a dedicated and skilled GMP expert to our innovative team at Alpha OV Therapeutics.