Main Purpose of Position:

Primary responsibility is to supervise the commercial manufacturing of SAIB, an excipient, in compliance with current Good Manufacturing Practices, applicable regulatory requirements, and DURECT policies and standard operating procedures.

Main Duties and Responsibilities:

• Produce GMP SAIB to meet forecast requirements. This includes supplying testing samples and the order of raw materials and supplies.
• Schedule manufacturing technicians, processing runs, and equipment use and cleaning.
• Coordinate shipping of finished goods and quality requirements and needs.
• Maintain facility and all required processing equipment to GMP standards. Work with Corporate Facilities group as needed to maintain all aspects of facility.
• Work with Engineering to execute protocols and implement process improvements.
• Ensure all Vacaville Manufacturing personnel are current with training requirements and comply with all safety procedures, SOPs, Batch Records, and cGMPs established for the Vacaville facility.
• Write and revise SOPs and Master Batch Records. Initiate, and/or review all deviation reports, investigation reports, and environmental excursion reports. Maintain security log (badge access).
• Maintain records in compliance with Good Documentation Practices for the Inventory and Waste Disposal Logs and Training, Equipment Maintenance, and Calibration Files.
• Schedule and oversee contractors.
• Manage personnel, write reviews and develop employee skill sets.

• Bachelor's Degree or equivalent, preferably in a science related field
• GMP/cGMP knowledge/training
• 6-8 years pharmaceutical GMP manufacturing
• 2-4 years Supervisory experience
• Hands on pharmaceutical processing experience
• Experience in writing/modifying SOPs/BPRs, etc.
• Forklift experience necessary (current license preferred)
• Experience representing manufacturing during regulatory and customer audits (PAI audit experience preferred)
• Track record of effective leadership and employee development
• Effective communication and coordination with all internal and external departments and locations
• Excellent time management skills
• Physical material handling and inventory management
• ERP/MRP competency a plus (QAD Mfg/Pro preferred)
• Computer literacy (Microsoft Office/Related Programs)

Working Conditions:

• Office, warehouse (cold and warm) and clean room manufacturing environment.
• Moderate physical activity which requires handling an average weight of 25-30 pounds with standing, turning, bending, climbing, pushing, stooping and walking for up to 8 hours per week.
• Handling 55-gallon drums utilizing forklift and pallet jacks.
• Work environment involves some exposure to physical risks such as operating dangerous equipment or working with chemicals.

DURECT Corporation is an Equal Opportunity Employer

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