Staci Spencer Email & Phone Number

Solely accountable for Quality Operations supporting Sware’s QMS, which include SaaS compliance and service delivery. Serve as leadership and core operations member.Key Contributions:• Revitalized the Quality Management System into a digital format by implementing an internal instance of Sware’s multi-tenant cloud platform, Res_Q.• Streamlined entire product validation process to reduce operational cost, increase GAMP 5/ERES compliance, and provide framework for AI capability.• Introduced Post-Implementation Review process on General Releases to cross-functionally assess observed incidents for root cause and corrective action to expedite the maturation of Sware’s SDLC and Release Management processes.• Continually defend Sware operations in customer audits and maintain a clean track record.• Implemented a formal process and strategy in handling and communicating defects.• Introduced Maintenance Release concept to implement and expedite bug fixes.• Mapped and updated internal procedures to ensure ISO 9001:2015 & SOC 2 audit readiness.• Established core operational programs such as Management Review, Business Continuity, and Personnel Training.• Provide insight and strategy on product ideation according to regulatory requirements.• Advocate and foster Quality Culture throughout operations.

Sacramento, California, United States

Managed a team of 4+ people to perform routine analytical assays and environmental monitoring to support manufacturing operations, product release and stability testing. Tasked with having to create core department SOPs, validate QC/EM equipment and assays for planned IND filing while maintaining laboratories in an operational and inspection-ready state.Key Contributions:• Created and established 20+ core procedures for both the Quality Control and Environmental Monitoring departments, which include but is not limited to: Assay Verification/Validation, Purchase and Receipt of Incoming Reagents/Consumables, Sample Handling, Equipment Calibration and Maintenance, Buffer Preparation and Storage, Water Sampling, Cleanroom Environmental Monitoring.• Authored 15+ analytical test procedures for product testing and created associated worksheets (MS Word and Excel) to document sample preparation calculations, equipment/consumables used, calculations for system-suitability and sample results, and specify the reported value(s).• Trained and mentored team members on how to create and develop 30+ analytical procedures and design software methods for assays that they were responsible for.• Served as the QC/EM lead reviewer and signature authority for inter-departmental related documents for 50+ documents to ensure that specified QC/EM department responsibilities were feasible, met regulatory compliance, and maintained internal standards.• Assessed equipment failure modes and product impact of 100+ QC/EM systems to determine necessary validation deliverables based on associated risk.• Created and executed validation deliverable documents (risk assessments, IQ/OQ/PQ protocols and validation summary reports) for 20+ equipment identified as high-risk.• Consistently remained under monthly/annual budgets to maintain manufacturer contracts, schedule preventative maintenance on laboratory equipment, and replenish consumables.

Sacramento, California, United States

Responsible for the establishment of cGMP manufacturing facility at CSPC Dophen by renovating the second floor to accommodate access-controlled operations for upstream (fermentation), downstream (cleanroom), material/product warehousing/quarantine, product testing, and vial inspection. Created a pharmaceutical Quality System and founded the Quality Assurance and Quality Control departments.Key Contributions:• Solely developed a Pharmaceutical Quality System (PQS) by authoring over 40+ Quality Management System (QMS) related procedures and policies.• Developed a QMS to function off a Shared Drive in lieu of an eQMS due to budgetary constraints.• Performed an international CDMO floor audit to oversee a $3 million contract for manufacturing drug substance (antibody).• Initiated and established an EH&S program for safety training and proper waste removal. Served on EH&S committee.• Participated in drafting pilot-sale manufacturing equipment validation documents, such as User Requirement Specifications (URS) for a 100L Fermenter and RABs Filling Machine.

Sacramento, California, United States

Responsible for researching and developing new ADCs (antibody drug conjugates) for future IND filings.Key Contributions:• Performed a gap assessment to determine facility improvements and obtain headquarters funding to construct a new cGMP facility for future IND filings after DP303c (ADC) IND filing was put on hold.

Vacaville, California, United States

Perform routine analytical assays and environmental monitoring to support manufacturing operations, product release and stability testing. Tasked with supporting the validation and launch of commercial manufacturing.Key Contributions:• Trained on 24 analytical assays utilized for release testing on in-process controls, intermediates, drug substance and finished product.• Verified and qualified 3 compendial test procedures: USP Chapters <785>, <788>, and <912>.• Developed 2 qualitative HPLC methods for analyzing residual EDTA and mPEG purity.• Appointed to be the subject matter expert (SME) on 11 analytical assays.• Performed continuous improvements to enhance assay accuracy, precision, and repeatability of analytical methods.• Helped establish an EH&S program and employee safety training program. Served on EH&S committee. • Executed laboratory investigations, resolutions, and CAPAs for deviations.• Established procedures to implement and qualify secondary reference standards.• Participated in HVAC, clean steam, WFI and PW validation activities of new clean room for commercial use.

San Diego, California, United States

Responsible for performing enzymatic assays for lot release, customer samples, and stability testing for all enzymes newly formulated and in market.Key Contributions:• Most diversely trained analyst within the QC team to be able to run assays for phytase, pyrolase, xylanase, amylase and Southern Blots.

San Diego, California, United States

Responsible for producing and harvesting Activin A from CHO (Chinese Hamster Ovary) cells, purifying protein via HPLCs and gel techniques, and preparing and running samples for mass spectrometry.Key Contributions:• Consistently performed proper sterilization technique in tissue culture with no cases of contamination.• Produced large concentrations of purified protein (Activin A) at high yields to aid department funding.

San Diego, California, United States

Performed proper clinical procedures to include blood tests, tissue samples, and fecal/urine analysis and provided assistance in surgery by administering anesthetics and monitoring life-support equipment.Key Contributions:• Established high school internship program.• Promoted to lead kennel caretaker within three months.