Shahrzad Stockman

• · Led and developed a team of up to 12 team members of varying proficiencies and levels. Hosted regular discussions with individuals about workload, projects, performance feedback, engagement, and development. Fostered a speak up culture by building trust tailored to each employees unique needs.
• · Coached an interim supervisor through all aspects of the employee lifecycle including hiring, onboarding, day to day management, performance management and counseling, and offboarding.
• · Established strong rapport with customers and network sites through collaboration meetings and discussions, informal and formal group presentations.
• · Direct oversight of lab functions related to microbiological testing of biopharmaceuticals at various stages of production, microbial identification and environmental/utility monitoring. Identified underperforming areas and oversaw implementation of process improvements.
• · Direct oversight of microbiological validation and studies, including development of 3 highly proficient validation coordinators and streamlining of studies/validation processes. Negotiated and balanced timelines between customer and team needs.
• · Direct oversight of microbiological control system and product specific test instruction review. Provided technical expertise and oversight for new and changing requirements.
• · Presented GMP microbiological labs and assays to health authorities during inspections. Ensured labs and employees were prepared for inspections, and responded to health authority observations and requests, resulting in zero major observations.
• · Regularly review and approve technical and validation protocols and reports, standard operating procedures and training material.
• · Safety team member and ergonomic advocate team leader for 2+ years. As ergo lead I developed a process for high risk assay identification and assessment and implemented training material and safety guidelines to minimize ergonomic injuries.
• · Regulatory submission (IND/BLA) authoring and review, including strategic responses to internal requests.
• · Subject matter expert in endotoxin and low endotoxin recovery with 10+ years of hands on experience. Contributed to development of network endotoxin procedure, low endotoxin recovery (LER) study design and network LER training protocol. Drove site specific actions to implement LER and mitigate beta glucan interference.
• · Adhoc member of biophorum group drug substance workstream. Collaborated with industry colleagues on the LER subteam to develop and execute 2 industry wide studies. One paper was published and the second I am leading and is in progress.
• · Developed and executed network periodic review procedure for microbiological methods.

Mosun, Glofit and Gant, Interim for Lebri

• Collected and analyzed biological data about relationships between organisms and environment.
• Interpreted research findings and summarized data into reports.
• Carried out quality control assessments for DNA analysis software.
• Assisted in manufacturing and testing of [Type] assays.
• Attended industry conferences to broaden knowledge.
• Managed overall laboratory functions.
• Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
• Performed routine maintenance and calibration on testing equipment.
• Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
• Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
• Conducted data review and followed standard practices to find solutions.
• Conducted investigations into questionable test results.
• Drafted technical documents such as deviation reports, testing protocol and trend analyses.
• Liaised between quality control and other departments and contractors, providing project updates and consultation.

• Evaluated components and final products against quality standards and manufacturing specifications.
• Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
• Noted trends in product quality and functionality to determine problem areas and plan for improvements to processes.
• Communicated with production team members about quality issues.