BONIFACE LIYAYI
Bellevue,WA
Summary
Highly motivated, detail-oriented Manufacturing Specialist in biotechnology with extensive experience in cGMP manufacturing processes. Proven leader on the manufacturing floor and dedicated to streamlining operations through continuous process improvement and cross-functional collaboration. Effective communicator with excellent time management, administrative and customer service skills. Knowledgeable—through education and experience, in theories and principles requisite in executing routine and non-routine tasks in the production of biologics from Phase I to Phase III in a cGMP environment.
Overview
10
10
years of professional experience
Work History
Specialist, Purification
Pfizer Inc. (previously Seagen Inc.)
05.2023 - Current
- Authored, collaborated, and reviewed 30+ SOPs from draft to approval.
- Collaborated and reviewed 10+ validation documents e.g. URS, DISA, SCS.
- Developed and reviewed 6 manufacturing training objects.
- Performed numerous activities related to commissioning and decommissioning of equipment.
- Witnessed FATs and reviewed executed documents
- Successfully completed level 1 and 2 training on MES i.e. PAS-X
- Subject Matter Expert on all operations related to purification processing
- Helped evaluate, develop, and implement new manufacturing technologies
- Proactively worked to achieve training competency in manufacturing operations
- Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
- Participated and supported continuous improvement culture
- Effectively collaborated with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities.
- Continuously worked with a sister facility to continuously improve legacy processes
Sr. Manufacturing Associate, Purification
Just-Evotec Biologics
05.2021 - 05.2023
- Floor lead for downstream unit operations e.g., column chromatography, VI, DF, VF, TFF and DS fill
- Used automation i.e., DeltaV, in continuous and batch manufacturing processes
- Led/trained team of 5+ manufacturing associates in downstream unit operations e.g., column packing, chromatography, DF, VF, and DS Equipment commissioning and qualification
- Created change controls, managing deviations and CAPAs using Quality Management Systems such as Compliance Quest
- Drafted/revised downstream standard operating procedures and manufacturing batch records
- Collaborated with departments such as Tech Ops, QC, QA, and F&E during deviation investigations and continuous process improvement.
Manufacturing Associate II, Purification
Catalent Inc.
02.2019 - 04.2021
- Led GMP and Engineering production campaigns for 3 different clients
- Trained manufacturing associates in executing SOPs, SMPs, and BPRs
- Performed column packing and chromatography using affinity, ion exchange, and size exclusion resin
- Wrote and tested recipes using AKTA chromatography skids
- Performed ultracentrifugation for protein purification
- Used single use manufacturing technology
- Used Quality Management Systems e.g., MasterControl and TrackWise to initiate/manage deviations and CAPAs
- Drafted and revised BPRs, SOPs, Protocols, and internal manufacturing specifications
- Engaged with clients to discuss process challenges and improvements.
Customer Service Rep/Prep and Flow
IKEA Company
04.2014 - 01.2019
- Trained and led team of 7 in customer service and warehousing.
- Collaborated with multiple departments to resolved customer issues related to lost/damaged furniture.
- Successfully increased product availability through space optimization using Excel.
- Used customer surveys to continuously improve customer experience.
- Maintained inventory and provided weekly reports to Ops manager.
Education
Bachelor of Science - Chemical Engineering
University of Maryland Baltimore County
Baltimore, MD05.2018
Skills
- Effective communication and organization skills
- Process Improvement
- Problem solving
- Training and mentorship
- Strong analytical and technical writing skills
- Collaborate effectively and efficiently in team environment
- Solid foundation in downstream unit operations
- eQMS eg, MasterControl, Compliance Quest, Trackwise, Veeva,
- Oracle, SAP
- Microsoft Office
Professional Memberships
- American Institute of Chemical Engineers (AIChe), 09/2013, Present, Member
- Safety & Chemical Engineering Education (SAChe) program, 05/2017, Present, Member
- Best Buddies International, 2017, Present, Volunteer
Affiliations
- Safety & Chemical Engineering Education (SAChe) program
- American Institute of Chemical Engineers (AIChe)
- Volunteer at Best Buddies International
Timeline
Specialist, Purification
Pfizer Inc. (previously Seagen Inc.)
05.2023 - Current
Sr. Manufacturing Associate, Purification
Just-Evotec Biologics
05.2021 - 05.2023
Manufacturing Associate II, Purification
Catalent Inc.
02.2019 - 04.2021
Customer Service Rep/Prep and Flow
IKEA Company
04.2014 - 01.2019
Bachelor of Science - Chemical Engineering
University of Maryland Baltimore County
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