Robert Sutherland Email & Phone Number

United States

United States

Scientific Delivery• Propose, initiate and implement improvements in routes, processes, material physical attributes or technologies to meet project objectives.• Design, execute and influence scientific work to meet the project timelines and objectives (e.g., selection of API version and form, conception and realization of viable new synthetic routes, design and scale up of unit operations such as crystallization and isolation, process transfer to commercial facilities, implementation of new technology or delivery of a suitable control strategy that includes the identification of key physical materials attributes).• Provide technical oversight of work performed at CROs.• Ensures that experimental work is interpreted and communicated to high standards of quality and effectiveness. Present effectively at internal R&D meetings. Project Leadership• Ensure appropriate scientific peer review and GXP standards.• Participate in technology transfer activities as appropriate to GSC, other parts of R&D, and partner CMOs. Documentation, Quality and Regulatory• contribute to regulatory submissions and approve regulatory submissions if required when delegated by director.• contribute to scientific papers and internal documentation such as development reports or controlled documents.• Comply with applicable Data Integrity, Quality, cGMP and regulatory requirements in all aspects of work.• Keep the department in compliance with regulatory requirements by following SOP guidelines, including those related to cGMP. If required, author or contribute to relevant documentation.• Maintain documentation, premises and equipment in compliance with cGMP where appropriate.• Established long term retention practices. Implement Data Stewardship practices and mapping associated with Data Champion objectives.• Characterization of sterile injectable suspension via Particle Size Analysis XRPD Rheometry and SEM

Upper Providence, Pennsylvania, United States

Material Scientist

Performs R&D activities and assay validations. Authors test methods and related technical documents. Executes R&D studies in correspondence with Supervisor or Technical leadExecute and draft QP, VP and other GMP methods, Drafts test methods RPs/SOPs client protocolsSupport in Assay transfer to Operations. Serve as trainer for new methods.Execute IQOQ and author equipment SOPs, PM Lab equipmentPrepare maintains Laboratory reagents GXPResponsible for monitoring and response systems for Lab equipmentConduct LIMS transactions

West Point Pa

Conduct various assays including DLS (Dynamic Light Scattering) DSC (Differential Scanning Calorimetry) ELISA and related plate-based assays Execute Polymerase Chain Reaction (PCR) electrophoresis testingConduct experiments to support development of large-scale process for viral particle and protein productionConduct experiments to develop purification processes producing purified biomolecules supporting vaccine researchCollaborate with varied departments by providing purification, characterization and expression support Perform GMP stability testing to support small molecule product development Document experimental results in electronic notebook format (ELN)Established proficiency with protein chemistry literature and related methodologyPerform peer review of dataSupport the final quality control approval for release to QAPresent experimental results to colleagues and managementCross train to support client in technical support

Performed bench work in accordance with GMP standards; examples include preparation of solutions and stability standards Assisted in extraction and purification of PF4 to support production and development of medical devices and blood testsConducted R & D experiments alongside production batches in preparation for validation, ELISA, and PCR ElectrophoresisCalibrated and maintained all equipment in Production and R & D LaboratoriesImplemented new techniques and instrumentation improving technical operations Became proficient with Good Laboratory Practices (GLP) and Chemical and Biological SafetyManaged direct reports in the design and execution of experiments, and compilation of results. Provided scientific input and recommendations to Project LeaderKept abreast of pertinent developments in the fields of medical devices and immunodiagnostics

Tested raw materials, stability samples and performed dissolution testing to support the existing solid dose project portfolio Calibrated and verified analytical balancesBecame proficient with HPLC UV, Dissolution FTIR and related GMP testing and documentation to support product developmentSupported the qualification, maintenance and calibration of production equipment in accordance with established schedulesUpdated existing SOP’s in the R & D laboratory.Assisted in equipment qualification and IQ/OQManaged the disposal of hazardous and non-hazardous wasteOrganized laboratory in compliance with 6S (Yellow Belt) and OSHA standardsManaged supply inventory and purchase requisitionsCollaborated with other departments supporting sitewide improvement initiativesServed as liaison in communicating with vendor representatives and reviewing quotes supporting sitewide cost reduction initiativesMaintained Certificate of Analysis documentation, USP reference standards and instrument logbooksCleaned and organized glassware for R & D LaboratoryCreated requisitions to procure lab equipment & supplies Managed inventory of laboratory, chemicals, supplies & equipmentGenerated monthly spending reports Maintained environmental controls according to SOPsAssisted the process validation/verification teams with equipment cleaning activtiesInspected work area assuring safety and cGMP housekeepingAccurately completed quality record logbooks

Oakland Nj

Oakland

Installing security fire and Home Entertainment Systems

Education record

Bachelor Of Applied Science - Basc, Biology, General