Job Code 201702
Vical is looking for a candidate who possess management and technical level experience in GMP biopharmaceutical manufacturing operations. The position reports to the Director of Manufacturing and will manage all aspects of Vical’s plasmid DNA bulk drug substance GMP manufacturing operations.
- Planning, and scheduling of all manufacturing activities.
- Manage and develop manufacturing staff.
- Review and approve executed manufacturing batch records.
- Conduct and/or develop Out-of-Specification/Out-of-Trend (OOS/OOT) investigations, nonconformance investigations, deviation reports, Corrective/Preventive Action (CAPA) plans.
- Monitor product quality and yields against production metrics.
- Provide cGMP guidance and technical training to manufacturing staff.
- Author, review and/or approve changes in manufacturing related documentation through a GMP change control system.
- Support process and equipment validations.
- Support internal and external audits.
- Ensure environment and personnel safety.
- Member of emergency response team, and manage manufacturing activities during off-hours (non-business hours and some weekends), as needed.
Skills and Experience
- Experience using bioprocessing equipment such as stirred-tank bioreactors, continuous flow centrifuges, ultrafiltration/diafiltration (UF/DF) skids, process tanks, chromatography skids, and automated CIP systems.
- Must have a minimum of 5 years supervisory-floor experience, and strong interpersonal and organization skills.
- Effective oral and written communication skills are essential.
- Commercial manufacturing experience desired.
A Bachelors or advanced degree in Chemical or Biochemical Engineering with a minimum of 10 years of experience in a biopharmaceutical manufacturing, and 5 years of direct supervisory experience.
Vical's Equal Employment Opportunity Policy
Vical is committed to a policy of equal employment opportunity. In keeping with our policy, Vical will recruit, hire, train and promote into all job titles the most qualified individuals, without regard for race, color, religion, sex, sexual orientation, national origin, ancestry, age, marital status, veteran status, disability, medical condition, usage of family and medical leave, or usage of pregnancy disability leave.