Process Support Supervisor

Zosano Pharma, Inc.

Location: Fremont, California-Oakland/East Bay 94555
Posted on: 9/30/2009 5:13:03 PM
Postion type: Full time
Job Code: 2009-25
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Process Support Supervisor

Zosano Pharma, Inc., is a private specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. Zosano Pharma is built upon the resourcefulness, talent, insight, and drive of our employees. We all share a common commitment to work toward achieving the Company’s goals. This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success.

The candidate who fills this position will be responsible for the support of the manufacturing process of a novel intradermal drug delivery device. The candidate will monitor performance of the manufacturing processes using SPC methods, correct equipment problems, analyze non-conforming products, remediate low yields, and correct product quality issues. This job requires the supervision of up to 4 professional staff.

The ideal candidate will have at least 5 to 7 years of relevant experience in the medical device and/or pharmaceutical industry and a BS or equivalent in a related discipline. Outstanding communication skills are essential.

DUTIES AND RESPONSIBILITIES (Other duties may be assigned):
• Managing staff responsible for the technical oversight of the manufacturing processes during production.
• Monitor the process critical attributes using SPC methods and issue monthly summary reports. Schedule regular reviews of production yield information.
• Create and upgrade operational procedures used by manufacturing personnel to perform production.
• Manage the investigation and resolution of process related yield issues. Identify primary process related factors affecting product quality and yield. Develop plans to remediate significant process issues.
• Managing the initiation, investigation, and resolution of process related non-conformances and CAPAs.
• Support the execution of process development investigations (organizing the build of experimental supplies, execution of experimental protocols, and analysis of data).

REQUIREMENTS:
• Previous management experience is required.
• Practical application of SPC methods to process control is desirable.
• Relevant knowledge of GXP compliance regulations and industry practices. Specifically, the requirements outlined in 21 CFR, Parts 210 & 211, and their practical application.
• Ability to critically evaluate, troubleshoot, and resolve production issues.
• The ability to prioritize and manage multiple projects concurrently under tight time constraints. Demonstrated commitment to proactive-planning and problem-solving.
• Must have computer skills including Microsoft Word, Excel, Power Point, Visio and Project
• Must be willing and able to work flexible hours (nights and weekends).

Zosano’s culture reflects the values of integrity, teamwork, innovation, performance, and a customer focus where high energy people join together everyday to surpass expectations. Zosano Pharma offers a competitive compensation & benefits program, along with all the excitement and energy you’d expect to find at a promising young start-up. To apply, please email your resume & cover letter to: hr@zosanopharma.com. Please reference Job Code #2009-25 and Process Support Supervisor in the subject title.

Zosano Pharma is proud to be an equal opportunity employer.
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