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Summary

Manufacturing Manager 
Job Code 201702
  

Description

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. 

Responsibilities  

  • 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.

Education Required

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.

 



Apply for this position    

HOW TO APPLY

To apply, please reference the specific job code in your cover letter and submit with your C.V. or résumé to Human Resources:

By email: hr@vical.com
By fax: 858-646-1154
By mail:
Human Resources
Vical Incorporated
10390 Pacific Center Court
San Diego, CA 92121-4340
U.S.A.
P. 858 646 1100 10390 Pacific Center Court, San Diego, California 92121
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