Richard Muttai Email & Phone Number

Virginia, United States

I contribute to the commissioning, qualification, and validation (CQV) program and ensure operational readiness for new pharmaceutical facilities. By conducting thorough CQV documentation reviews, I ensure adherence to quality compliance standards. My efforts support CQV initiatives and prepare new utilities and process equipment, thereby enhancing operational efficiency.In my role, I provide on-site quality engineering and risk management during validation processes, utilizing tools such as FMEA/PFMEA to ensure maximum safety and reliability. By analyzing test results, I identify deviations and recommend corrective actions to bolster compliance. Through fostering cross-functional collaboration, I streamline validation efforts and ensure alignment with project objectives.

Virginia, United States

I contribute to the commissioning, qualification, and validation (CQV) program and ensure operational readiness for new pharmaceutical facilities. By conducting thorough CQV documentation reviews, I ensure adherence to quality compliance standards. My efforts support CQV initiatives and prepare new utilities and process equipment, thereby enhancing operational efficiency.In my role, I provide on-site quality engineering and risk management during validation processes, utilizing tools such as FMEA/PFMEA to ensure maximum safety and reliability. By analyzing test results, I identify deviations and recommend corrective actions to bolster compliance. Through fostering cross-functional collaboration, I streamline validation efforts and ensure alignment with project objectives.

Grottoes, Virginia, United States

As a member of the Board of Zoning Appeals, I get to hear and decide appeals from any decision or determination made by the zoning administrator and to authorize variances from the laws set forth in the Zoning Ordinance as set forth by the Town of Grottoes, VA.

Grottoes, Virginia, United States

Respond to emergency calls in the community.Organize community events

United States

I strengthened international technical support for drug substance manufacturing from clinical development to commercial supply distribution. By revitalizing MS&T teams across multiple sites, I improved GMP operations through strategic hiring, training, and process optimization.I consistently met global raw material demands by enhancing forecasting, collaborating across supply chains, and overseeing process validation and technology transfers. I ensured that DS manufacturing sites comply with global quality systems and regulatory standards, thereby enhancing process comparability and control strategies.Additionally, I enhanced team performance and governance by coaching and mentoring junior and CMC team members, fostering professional growth and development.

Maryland, United States

I established, improved, and maintained quality standards, systems, and controls across four sites, ensuring consistent excellence in production. By leading the entire manufacturing lifecycle, I enhanced product quality and efficiency from feasibility to clinical trials, with a strong emphasis on swift deviation resolution and new product technology transfers.I optimized project management by streamlining task oversight, report generation, quality metric analysis, new product introductions, and validation processes. Through close collaboration with Manufacturing, Engineering, and Facilities teams, I ensured strict compliance with cGMP standards.Additionally, I maintained high-quality standards in alignment with regulatory and company requirements by conducting detailed reviews of critical documents and validations, thereby upholding equipment and process integrity.

United States

I successfully built and improved quality systems and collaborated with team members across sister sites in Europe, Canada, and the United States. I directed Quality Control and LIMS sample management, effectively leading the QA OTF team to ensure alignment with client expectations, achieve on-time delivery, and provide continuous operations support, all while maintaining programs inspection-ready.I enhanced site operations by defining and executing QA OTF roles and responsibilities. As a key member of the Bayview Quality Operations management team, I contributed to the assessment and investigation of deviations. I guided the tech transfer from clinical to commercial stages by optimizing batch records and collaborating with MS&T for product development and optimization.In addition, I actively engaged in FDA and other regulatory inspections, advocated for quality practices, and ensured compliance across all facets of quality management.

United States

I performed and monitored day-to-day manufacturing operations, ensuring compliant execution with cGMP standards and procedures within the cGMP manufacturing areas. I ensured strict adherence to company policies, GMP standards, and safety procedures while overseeing tech transfer and the development of products from clinical trials to commercialization.I proactively identified and escalated critical issues, facilitating cross-functional collaboration in manufacturing initiatives and generating key documentation such as Batch Records and SOPs. As a subject matter expert, I actively contributed to continuous improvement efforts and supported Management Development programs to implement effective management tools and ensure alignment with company goals.Additionally, I built and maintained strong interdepartmental relationships, supported regulatory audits, and ensured the seamless execution of processes to uphold quality and operational efficiency.

Baltimore, Maryland, United States

I operated pharmaceutical manufacturing equipment, including depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment. I demonstrated exemplary adherence to Emergent policies, GMP standards, and safety procedures, while providing pivotal support to Validation, Engineering, and Facilities teams in the operation of manufacturing equipment.I enhanced team goals through collaborative efforts across manufacturing process teams and EMOB groups, and played a key role in supporting QA during audits and regulatory inspections.

Baltimore, Maryland Area

Completed Batch Production Records under cGMP and documented in detail using SOPs and BPRs for the processes and manufacturing steps.•Led tech transfer and product development from clinical to commercial stages, crafting essential protocols and documentation, including SOPs, deviations, and summary reports, while spearheading the resolution of deviations and CAPAs.•Fostered collaborative relationships with production management, MS&T, and clients to streamline manufacturing projects, ensuring operational efficiency, and meeting contract objectives without delays.

Rockville, Md

• Completing daily manufacturing tasks per SOPs and batch document instructions• Monitor critical process parameters and document all manufacturing activities clearly and accurately• Ensure all processing equipment and materials necessary are adequate and available to set the team up for success • Ensures all production activities are completed in a safe and compliant manor• Maintain and prepare high quality documentation• Dispense large and small amounts of raw materials • Perform CIP and SIP of product tanks• Work with hazardous materials under the appropriate safety procedures• Chromatographic separation• UF/DF operation• Start-up and product changeover activities

Newark, De

" Manufacture of Intermediates and Concentrates for use in LOCI Reagents" Manufacture of Loci reagents used in immunodiagnostic assays" Operation of spectrophotometer, pH meter, centrifuge, Pump and UV detector" Document all such activities accurately in standard production worksheets as part of Device History Record" Set up and use of pumps, filtration and diafiltration equipment and sonicator" Maintain the area procedures as prescribed" Comply with all regulatory agency requirements" Maintain high efficiency in operations" Update documents as needed in support of process improvement activities" Understand the basics of antibody-antigen interactions" Interact with R&D and other functional organizations as needed

Newark, De

•Manufacture and test Chemistry & Immunochemistry reagents/calibrators for SYVA, Advia, Immulite, OEM, DM, and Vista.•Perform instrument maintenance and operate manufacturing equipment.•Comply with quality systems and regulatory agencies (not limited to): FDA, DEA, ISO, OSHA.•Operate within all company policies and procedures.•Effectively collaborate with cross functional team.•Support and drive continuous improvements and area projects.•Work independently and also as part of a team.•Perform troubleshooting and root cause determination.•Handle controlled substances within regulation•Possess comprehensive working knowledge of a technical or specialty area, and of operations, methods, and practices•Perform complex manufacturing and quality control processes of radiopharmaceuticals•Operation and performance of complex adjustments to manufacturing and test equipment and instruments•Performance of complex investigations for process deviations and out of specification results

Newark, De

• Formulate reagents and calibrators for Dimension, Vista and Stratus CS product lines.• Follow production worksheets and area procedures.• Properly documents production steps in batch records by following GDP.• Complies with quality system and regulatory agencies.• Operates manufacturing equipment.• Clean and clear laboratory and work area.• Perform maintenance of equipment, e.g. pH Meter.• Calibrate pH Meter prior to use.

Newark, De

• Formulate reagents and calibrators for Dimension, Vista and Stratus CS product lines.• Follow production worksheets and area procedures.• Properly documents production steps in batch records by following GDP.• Complies with quality system and regulatory agencies.• Operates manufacturing equipment.• Clean and clear laboratory and work area.• Perform maintenance of equipment, e.g. pH Meter.• Calibrate pH Meter prior to use.

Philadelphia

Collect and advice patients of their insurance coverage, verify insurance coverage and schedule patients doctors appointments.

Administer medications to the mentally disabledComplete Medication Administration Records book Monitor clients nutrition and general healthPrepare and serve food to clientsTransport clients

o Administer medications to the mentally disabledo Complete Medication Administration Records book o Monitor clients nutrition and general healtho Prepare and serve food to clientso Transport clients

With my time at Delaware Tech, and Internship at the University of California-Davis and at Delaware Biotechnology Institute, I had a hands-on experience in growth media preparation, overnight culture preparation, PCR purification, gram staining, gel electrophoresis, western plot, yeast fermentation, cloning, titration, solution preparation, and autoclaving. I also did an independent research at Delaware Tech on the production of antibiotics by Actinomycetes. I was also able to set up a new imaging machine just by following the provided SOP. In all my work I apply GLP and keep a good and detailed lab notebook

Bachelor Of Science - Bs, Biotechnology

Associate Of Science - As, Biotechnology

Associate Of Science - As, Chemistry Technology