Brad Valentine Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Seattle, Washington, United States

• Served as Process Characterization lead on supporting Breyanzi regulatory activities including authoring of responses to questions (RTQs) from EU and CHE regulatory agencies.• Authored business-critical technical reports and assessments to support Breyanzi label expansion.• Served as Process Characterization Subject Matter Expert (SME) on cross-functional Breyanzi technical development team.• Independently designed and executed small-scale and at-scale DoE studies to generate data to support the process control strategy and range justifications for Breyanzi.• Performed statistical analysis on characterization data using JMP software.• Authored reports to support process parameter criticality and justify acceptable ranges for process parameters.

Seattle, Washington, United States

Greater Philadelphia Area

• Scientist contributing to the development of early and late stage clinical manufacturing processes and commercial manufacturing processes for Cell Therapies. • Ability to independently design experiments using DOE principles, followed by independent execution and analysis of data using JMP software.• Proficiency in experiment design, execution, and interpretation of study results to optimize bioprocesses.• Member of the Process Development Safety Committee. • Development of Cell Therapy process from manual, small-scale research protocol to an automated, closed GMP ready demo.• Experience in integrating new technologies and equipment for Cell Therapy Manufacturing.• Responsible for successful process development and technology transfer of adherent and suspension primary cell lines.• Provides support Technology Transfer activities, Pilot Process Development and GMP manufacturing.• Proven adaptability to meet project timeline and milestones.

Greater Philadelphia Area

• Responsible for cGMP manufacturing of mammalian cell cultures for cell therapies, working cell banks, and final product fills.• Assisted Process Development in scale-up and tech transfer of bioprocesses from client to clinical operations.• Authored and executed Pilot Run, Aseptic Process Validation (APV), and GMP batch records.• Performed Validations and Qualifications for laboratory equipment.• Adhered to current good manufacturing practices (cGMP) and standard operating procedures (SOP’s).• Developed Sampling requirements document for use in LIMS in accordance with cGMP processing.• Trained technicians on techniques and equipment. • Interacted with Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups.• Completed production records and maintained clean room environment to comply with regulatory requirements.• Fully trained in GMP operations for commercial manufacturing.

Philadelphia, Pa

• Ensured quality of the product was up to current good manufacturing practices (cGMP) by following standard operating procedures (SOP’s).• Followed current good documentation practices (cGDP) to meet FDA regulations and guidelines. • Worked and coordinated with multiple departments to release final product. • Ensured Acceptable Quality Limits were within range for each batch.