Responsibilities

• Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
• Ensure the quality control lab is held to GxP standards and safety standards
• Create/Review and approve Certificate of Analysis
• Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
• Review and approve data to ensure accuracy and regulatory compliance
• Collaborate with QC Microbiology management in establishing specifications and justification of specifications
• Create/Review and approve new and revision of analytical test methods
• Create/Review and approve method validation protocols/reports and other documentation such as analytical reports
• Create/Review and approve stability protocols and reports
• Create/Review and approve quality control operation procedures
• Manage the validation of analytical methods used in QC as well as the transfer and validation of methods to contract testing laboratories
• Manage training of other analysts to perform laboratory procedures and assays
• Participate in internal assessments and audits as required
• Manage stability program
• Serve as Quality Control representative during cross-functional/project meetings
• Serve as subject matter expert between Quality Control and other departments, vendors, or contractors
• Behave as a working backup QC analyst for testing activities as needed
• Support Quality Systems such as Change Control, Deviation, CAPA, Audits, Quality Metrics
• Manage and grow a phase appropriate team of Quality Control personnel
• Establish user requirements for purchase of new Cellares GMP lab equipment
• Manage equipment validation, calibration, maintenance, and troubleshooting
• Assemble and report contract laboratory testing data
• Assist in the preparation of dossiers and data packages in support of Cellares products for regulatory agencies
• Other duties as assigned.

Requirements

• BA or B.S. degree in a science discipline required, or comparable experience.  M.S. in a scientific discipline is preferred
• Minimum of 7 years experience in a cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
• At least 2 years in a managerial role
• Prior experience related to method development/validation
• Strong background in cell biology, immunology, and molecular biology
• Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211.
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, analytical testing, and auditing
• Identifying, authoring, and supporting OOS, DRs, and CAPAs
• Equipment IQ/OQ/PQ experience
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Excellent interpersonal, verbal, written communication and organization skills
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
• Must be able to commute to South San Francisco