BS in Pharmaceutical Sciences or related field required
5-7 years of experience in a regulated industry
Knowledge of quality management systems is a must
Preferred experience with biologics and pre-filled syringes
Experience in a cGMP environment necessary
Validation and technology transfer experience is a plus
Ability to learn quickly and make sound scientific decisions
Responsibilities
Develop, implement, and manage quality system procedures
Represent QA in technology transfer and process validation at CMO sites
Investigate deviations and implement CAPAs as necessary
Review and approve analytical data and batch records
Support audits and maintain regulatory submissions
Identify KPIs and drive continuous improvement
Coordinate with cross-functional departments for problem-solving
Benefits
Opportunity to work on-site at Kodiak's headquarters in Palo Alto, CA
Engagement in cutting-edge biologics and drug delivery systems
Exposure to regulatory submissions and compliance efforts
Participation in both internal and external audits
Part of a collaborative environment with cross-functional teams
Full Job Description
Description
This team member is responsible for developing, implementing, and managing Quality operations system in the organization to ensure compliance of biological products with cGMP and regulatory requirements. This role is on-site at Kodiak's headquarters in Palo Alto, CA.
Key Responsibilities
Develop, implement, and manage quality system procedures.
Represent QA in supporting technology transfer and process validation activities at CMO sites.
Investigate deviations and implement CAPAs as needed.
Review and approve analytical data and batch records.
Review and release drug substance and drug product batch documents.
Support internal and external audits as needed.
Maintain and support regulatory submissions as needed.
Identify KPIs and establish and drive continuous improvement to maximize efficiencies in the quality processes.
Coordinate with cross functional departments for routine work and problem solving
Support development of Pre-Filled Syringe (PFS) for intravitreal delivery of viscous drug product
Support Bioanalytical lab in developing operational procedures, provide quality oversight for method validation and compliance efforts to meet GLP/GCLP requirements.
Support Computer System Validation (CSV) activities for digital systems impacting GxP activities.
Support active clinical trial supply and demand activities,
Supports any additional projects assigned by Senior Management.
Education/Experience
At least a BS in Pharmaceutical Sciences or related field.
5-7 years of technical experience within regulated industry.
Experience and knowledge of quality management system required.
Preferred experience with biologics and pre-filled syringe.
Experience in analytical methods, equipment/facilities validation and technology transfer experience is a plus.
Experience in a cGMP environment is required, and experience in supplier management is a plus.
Ability to learn quickly and make sound, scientifically driven decisions that align with regulatory requirements.
