Roy Domingo

As the Training Manager, I administer Sutro’s training program by working with cross functional departments throughout the company to ensure that personnel are knowledgeable, qualified, and proficient with the requirements related to their functional role. In addition, I champion the continuous improvement for GxP training and development programs ensuring that all employees and are compliant with regulatory and corporate quality standards.

Responsible for establishing/updating/executing cGMP Quality Operation activities including Change Control, Deviation Management, CAPA Management and Line Clearance in support of reagents and product manufacturing.

Engage in the implementation and management of various aspects in QMS including, but not limited to, Document Control, Deviation, Nonconformance, CAPA and Risk Management, Validation Master Plan, Change Control, and Customer Complaints management in a GMP and RUO manufacturing environment. Along with batch record, validation packages, and Drug Substance Final Product approval, I support internal, external, customer, and regulatory audits.

Ensure overall Quality Management System (QMS) compliance and up-to-date understanding of applicable laws and regulations so that the company’s risks are identified and managed appropriately.

In support of Integrated Facility Management (IFM) as Quality Lead, I am responsible for ensuring the work conducted by the IFM team and its subcontractors perform the work in full accordance and compliance with JLL standards, BMS Policies and procedures, and cGxP regulations as they relate to the performance of maintenance and repairs to equipment and facility utilized in an R&D workplace environment. In addition to RWC responsibilities, I track and maintain the Document Management System used on the BMS account for preparing/revising/submitting SOPs, Work Instructions, and Policy documents at facilities in CA, East Coast, and Puerto Rico.

Conducts internal audits for compliance and investigates customer complaints in order to establish root cause and generate Corrective and Preventative Actions (CAPA) to prevent reoccurrences of on-going issues. Responsible for conducting and coordinating investigations, revises and maintains documentation (i.e. SOPs), and ensures conformance to in-house specifications and cGMP/ISO standards as well as local, state, national and international regulations.

Provides technical service, customer training, and sales support for the QAP program in Clinical QC. Troubleshoots, resolves technical problems, and assist customers in maintaining the integrity of QC to effectively validate instrument performance.

In collaboration with team members, I am charged with transferring confidential information from the SLIMS database to the GLIMS database. Performs data entry into GLIMS. Reviews data entered into database for accuracy. Maintains well-organized records. Exercises compliance of company SOPs to ensure the safeguard of data integrity.

As a discrepancy investigator for the Active Pharmaceutical Ingredient (API) Department, I investigated deviations or adverse events within the Plasma, Media/Fermentation, and Purification Department to determine the impact to the quality and safety of the product. Investigations include but are not limited to production processes, equipment, facilities, raw material, environmental monitoring, documentation, and personnel. Wrote clear and concise reports of investigations and formulated Corrective and Preventative Actions (CAPAs). I consistently completed investigations within strict timeline requirements. Recovered approximately $25M per year from potential discards of the product through investigations. In addition, I reduced production cost of $0.5M per year in meeting business goals by reducing discrepancy incidents, revision of Batch Production Record (BPRs), and Change Control Requests (CCRs) for chromatography skid pauses and residence times.

As interim supervisor, I assisted production in maintaining facility cleanliness of Media, Fermentation, and Purification per cGMP for Class D and E areas. Managed and delegated daily operational duties for fifteen union facility cleaners. Accountable for ensuring all duties and responsibilities were properly performed. Coordinated special cleaning of facilities with production, QA, and QC. Ensured facility cleaners were qualified in the most current Standard Operating Procedure (SOPs), Health and Environmental Safety (HES), and cGMP training. Succeeded in aligning building operations through product and material flow-through to improve work efficiency. Implemented Standard of Work project to increase work efficiency Project manager of several concurrent improvement projects including procurement of reformulated rust removal solution, implementation of cleaning labels to decrease amount of paper used.

In support of laboratory production, I maintained, coordinated, and delivered training modules to approximately sixty supervisors, production technicians, and general workers in the Purification Department. Developed and maintained the new hire program to cut orientation time in half. Additionally, I was responsible for cGMP and HES training. Reviewed and revised SOP curriculum. Audited training forms, binders, and spreadsheets to keep the Purification Department from incurring Incident Reports (IRs) on training development. Strict compliance of all regulations in performance of production to ensure the safety and purity of the product.

Through combined efforts, my associates and I were charged with the manufacturing and processing of rFVIII for the production of medication to hemophilia patients. The ability to work well in a team project environment is key. Oversee the fermentation, harvesting, sample testing through quality assurance and collecting of product to be sent for purification. Supporting duties include tube assembly, media verification, fermenter cell counts, Ultrafiltration and Cell Separation skid cleaning. As a Job Safety Behavior Observation (JSBO) Steering Team member, I collaborated in developing and initiating the project's infrastructure, designing the database, and encouraged safe behaviors to ensure a hazard free environment.

Cooperating with other team members, I am appointed with the loading of up to eight ABI 3900 DNA Synthesis machines in a high-throughput production atmosphere. I synthesize DNA probes and primers through critical and crucial chemical reactions specifically designed by customer request.

In a production environment, I was responsible for high-throughput (HTPS) DNA purification and the operation of eight MegaBACE DNA sequencers. Used various molecular biological techniques from cloning transformation to PCR amplification and plasmid DNA purification.

I supervised and assigned daily duties for a team of five to ten direct reports. Principle responsibilities included viral phage assays, clone management and inventory. Assisted with process flow development and played a key role in developing, validating and implementing pLIMS inventory system. Collaborated in creating, writing and training of SOP protocols to standardize quality assurance.