Patricia Marcellus

Bilingual scientist and laboratory professional with 10+ years of experience spanning biopharmaceutical stability programs, laboratory operations, manufacturing, clinical specimen processing, and regulated environments. Experienced in cGMP compliance, stability study management, sample inventory and distribution, technical documentation, deviation tracking, SOPs, laboratory systems, and cross-functional collaboration. Strong background in supporting regulatory commitments, training personnel, managing laboratory resources, and maintaining accurate documentation in highly regulated environments.

Fluent in English, Haitian Creole and French.

Scientist; Senior Associate Scientist; Associate Scientist - Bristol-Myers Squibb

(2019-09 - 2026-02)

Associate Scientist contracted through SpectraForce Technologies

• Supported development and revision of stability study protocols, SOPs, and related documentation in accordance with cGMP and regulatory requirements.
• Managed stability sample activities, including global sample pulls, distribution, labeling, inventory, storage, retrieval, and disposal.
• Coordinated stability sample pulls with protocol requirements and communicated issues that could affect laboratory capacity, product studies, or regulatory commitments.
• Documented and evaluated stability-related deviations, including temperature and humidity excursions and sample inventory discrepancies, for compliance impact.
• Prepared technical report sections related to sample storage and sample management for OOS/OOT investigations as needed.
• Supported monthly stability performance metrics and stability program reporting.
• Maintained stability documentation and ensured studies were performed according to approved protocols, procedures, policies, and guidelines.
• Served as a resource for site departments and cross-functional groups requiring stability program data and study information.
• Coordinated library sample pulls, distribution, inventory management, and disposal at third-party facilities.
• Maintained sample inventory using the Foot-Print inventory system and supported data entry and verification using JMP Files and LIMS 12.
• Prepared stability study reports for testing sites and facilitated retrieval of stability study data for special requests.
• Supported enrollment packet preparation and document management activities.
• Interacted effectively with inspectors during facility tours and inspections.
• Trained new employees and team members participating in cross-training activities.
• Trained and developed within the Stability Trending Program.
• Maintained a safe and compliant working environment and adhered to applicable safety procedures.

Manufacturing Associate - Moderna

(2023-03 - 2023-06)

Contracted through Randstad

• Executed manufacturing operations using disposable technologies, automation, and Manufacturing Execution Systems (MES) to support mRNA production.
• Partnered closely with Quality Assurance to support rapid disposition of mRNA.
• Monitored manufacturing processes to ensure compliance with specifications and current cGMP requirements.
• Supported investigations of procedural deviations.
• Followed written procedures for equipment operation, process instructions, and accurate data documentation.
• Maintained clean and controlled manufacturing areas and followed gowning and safety requirements.

Lab and Phlebotomist Manager; Lab Coordinator/Phlebotomist - Instrumentation Laboratory

(2016-08 - 2019-09)

• Managed the Critical Care Analytical Laboratory within the R&D organization, supporting scientists and engineers.
• Collaborated with project managers across Chemstat and 5K projects to plan and prepare GMP/cGMP documentation.
• Assisted with development of protocols for the blood program, laboratory instruments, and Chemstat SOP projects.
• Ensured laboratory activities complied with protocols and regulatory requirements.
• Coordinated communication between Manufacturing and R&D to maintain project progress.
• Managed laboratory chemicals, specialized reagents, inventory, supplies, equipment, instruments, and gas tanks.
• Coordinated sample pickups from external laboratories for internal testing and research projects.
• Managed the Blood Program and trained new employees.
• Coordinated ordering of phlebotomy, laboratory, gas, and ABL supplies.
• Coordinated biohazard waste disposal, equipment repairs, temperature monitoring, and tonometry maintenance.
• Performed pipette and analyzer calibrations, equipment troubleshooting, and audit preparation activities.
• Served as laboratory safety coordinator and emergency personnel while maintaining laboratory cleanliness and safety.
• Implemented laboratory procedures and training requirements among laboratory personnel.
• Maintained project files and supported departmental and project budgets.
• Reviewed and approved vendor invoices.
• Supported interviews, administrative activities, and other laboratory operations.

Specimen Processor/Lab Control - Massachusetts General Hospital

(2016-03 - 2016-06)

Contracted through Aerotek

• Screened requisitions and documented errors in tracking systems for follow-up.
• Identified high-priority issues and communicated them to project leadership for timely resolution.
• Scanned requisitions and generated additional labels when required.
• Transported laboratory specimens and printed/reprinted requisitions.
• Handled blood, urine, swabs, and tissue specimens in accordance with laboratory procedures.

Specimen Processor / Phlebotomist / Lab Technician - Reprosource Fertility Diagnostics

(2015-08 - 2016-07)

• Processed incoming and outgoing clinical samples for external laboratory testing, including labeling and shipment tracking.
• Performed all aspects of clinical sample accessioning, including sample verification, data entry, labeling, centrifugation, and aliquoting.
• Performed quality control checks throughout the sample workflow and monitored sample chain of custody.
• Managed clinical human blood and serum samples in accordance with blood-borne pathogen safety requirements and HIPAA procedures.
• Worked according to CLSI, CAP, and CLIA laboratory procedures and documentation requirements.
• Facilitated client special requests and maintained electronic documentation.
• Performed venipuncture for research, controls, and patient specimens.
• Developed policies and procedures and trained employees in phlebotomy and sample handling.
• Provided general administrative and laboratory support.

Lab Assistant / Lab Control - Brigham and Women's Hospital

(2015-04 - 2015-08)

Contracted through Aerotek

• Identified and labeled laboratory specimens.
• Entered specimen demographics and test orders into the laboratory system.
• Added tests to appropriate specimen types as requested.
• Processed routine and STAT specimens and performed specimen aliquoting.

Bachelor of Science - Biology, Minor: Chemistry - Salem State University (2013)

Phlebotomy/EKG Technician Certificate - Medical Professional Institute (2014)