NICHOLAS RAIFORD
Deforest,Wisconsin
Summary
Data and metrics driven Quality Control Operations Manager with 14 years of experience at top CROs and CDMOs. Strong organizational abilities with proven success managing multiple projects simultaneously. Resourceful leader who works well under pressure and who is a team player. Committed to a quality mindset and to further the mission of the company.
Overview
12
12
years of professional experience
Work History
Senior Manager - Quality Control
MilliporeSigma
10.2022 - Current
- 6 Supervisors as direct reports for Raw Materials, EM, and IPC/Final Release/Stability
- Responsible for 55 total QC staff members across two HPAPI facilities at the Madison and Verona sites
- Oversee 5 different shifts to ensure 24/7 QC testing coverage
- Set up and tracked annual CAPEX and OPEX budgets for QC
- Serves as main point of contact for QC operations to help maintain the production schedule
- Established Smartsheet use to help with scheduling, planning, and resource modeling for site visibility
- Improved culture and career development ladder to help with employee retention
QC Manager (Head of QC)
Walter Reed Army Institute of Research
06.2022 - 10.2022
- Oversee all quality control functions including EM, GMP testing, Stability testing, and Analytical Development
- 15 direct reports including QC cleaning technicians, scientists, and supervisors
- Work closely with business development and clients for contract lab testing and assay development
- Established testing criteria for bacterial and viral vaccines for clients
- Responsible for lab equipment orders, SOP drafting, COAs, and data review.
Manager - QC Technical Operations
Catalent
01.2022 - 06.2022
- Managed the Quality Control technical operations at multiple Cell & Gene Therapy sites within Maryland
- Lead a team of 30+ data reviewers, sample coordinators, data coordinators, and planners
- Responsible for leading all sample management activities including sample receipt, sample storage, sample shipping, aliquoting, and critical reagent inventory
- Responsible for all data management activities including product specification builds, COA and COT generation, and PPQR submissions to commercial clients
- Dispositioned over 200 batches of COVID-19 drug substance for a major pharmaceutical company
Supervisor - QC Planning & Data Management
Catalent
02.2021 - 01.2022
- Responsible for on-time delivery of all QC data to support lot release
- Supervised a team of 10+ including a QC planner, QC data coordinators, and QC data reviewers
- Responsible for coordinating and planning lab activities across PD, AD, QC, and MFG teams
- Responsible for the creation and revision of product specifications, batch records, and sampling plans
Quality Control Planner/Scheduler
Catalent
08.2019 - 02.2021
- Followed up with testing and turnaround times to ensure testing deadlines are met
- Worked closely with manufacturing, analytical development and process development for scheduling of testing to the QC lab
- Interacted with project managers on tests pending, data results, and timelines Created and maintained Smartsheet trackers for all QC samples received
- Assigned analytical and micro testing across three shifts
- Coordinated daily schedules for analysts and acted as QC project manager
- Effectively communicated updates and results for internal and external stakeholders
- Trended data results and interpretation of data trends as needed
- Routinely updated department metrics and KPIs
- Championed operational improvements for the QC group by participating in Kaizens, creating optimized data managment processes, and building scheduling tools
QC Consultant
Emergent BioSolutions
01.2019 - 08.2019
- Performed activities related to sample receipt and storage, aseptic technique sample aliquoting for Biosafety Level 1 to 3 products, and transport of samples internally / externally while ensuring documented chain of custody.
- Used LIMS, .JMP, Microsoft Office and other software applications to maintain, track and trend QC analytical data, inventory and other critical information.
- Performed QC solution preparation using laboratory controls.
- Executed duties associated with laboratory inventory management of chemicals, critical reagents and supplies.
- Assisted with planning and coordinating sample shipments to contract testing laboratories or off-site storage facilities.
- Performed laboratory housekeeping activities as part of QC Support, which includes laboratory cleaning, manual glassware cleaning, use autoclaves and glasswashers.
- Performed other duties as assigned in support of QC Laboratory operations such as QC testing, data review and maintaining QC laboratory systems.
Scientist I
BioAgilytix
01.2017 - 09.2018
- Developed, optimized, qualified, and validated ELISA assays in support of large molecule bioanalysis for preclinical and clinical studies in a regulated GCLP, GCP, GLP, and FDA supported environment
- Validated ADA and biomarker assays for phase 1-4 studies for the company’s largest client
- Prioritized client retention and satisfaction by completing fast turnaround projects and working weekend hours as needed
- Expedited project timelines to reduce cost and increase revenue
- Promptly authored validation reports, methods, and sample analysis reports
- Conducted analyses of data, managed data, and performed internal data review to ensure accuracy, consistency, and reproducibility of data and to document trends in analyses
- Acted as a mentor in the lab to train and develop new scientists
Senior Scientist
PPD
04.2016 - 01.2017
- Acted as project manager for multiple projects to coordinate sample analysis and communicate project deliverables with the client
- Led a team of scientists and handled daily scheduling including testing, data review, and sample management activities
- Successfully developed and validated assays for clients specializing in large molecule biosimilars
- Coordinated stability analysis for bioassays and responsible for biotinylating and tagging proteins and target molecules
- Reviewed electronic and manual bench sheets and notebooks prior to QC and QA submission
- Developed and implemented a skills matrix for the biosimilars team to help with career development Acted as lead scientist on a method transfer from a non-GLP laboratory for a prospective client
- Effectively communicated across departments to ensure timely deliverables.
Scientist
PPD
01.2012 - 04.2016
- Qualified cell-based assay analyst performing clinical and non-clinical assays in BSL-2 safety cabinets
- Utilized ImmunoSpot software to digitally count bacteria colonies
- Responsible for REES laboratory monitoring for incubators, refrigerators, and freezers
- Utilized Hamilton liquid handling robotics to create sample dilutions and controls for a high throughput lab
- Performed IQ, OQ, and PQ on Hamilton robotics for a rapidly growing vaccine lab
- Reviewed all Hamilton documentation for 100% correctness.
Education
BS Biology -
Virginia Wesleyan College
Norfolk, VA05.2010
Skills
- Ability to Work Under Pressure
- Biomarker Assays
- Ability to Work in a Team
- ADA Assays
- Microsoft Excel
- QC Data Review
- Communication Skills
- GLP
- Creative Problem Solving
- Report Writing
- Microsoft Office
- Data Analysis
- Hamilton Robotics
- Project Management
- Tecan Robotics
- GLIMS
- Assay Development
- MSD
- Assay Validation
- Cell-Based Assays
- Sample Analysis
- PK Assays
- ELISA
Timeline
Senior Manager - Quality Control
MilliporeSigma
10.2022 - Current
QC Manager (Head of QC)
Walter Reed Army Institute of Research
06.2022 - 10.2022
Manager - QC Technical Operations
Catalent
01.2022 - 06.2022
Supervisor - QC Planning & Data Management
Catalent
02.2021 - 01.2022
Quality Control Planner/Scheduler
Catalent
08.2019 - 02.2021
QC Consultant
Emergent BioSolutions
01.2019 - 08.2019
Scientist I
BioAgilytix
01.2017 - 09.2018
Senior Scientist
PPD
04.2016 - 01.2017
Scientist
PPD
01.2012 - 04.2016
BS Biology -
Virginia Wesleyan College
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