AUGUSTINE KUFFOUR
Oakland
Summary
Disciplined Manufacturing Supervisor looking to build upon skills and tackle new responsibilities. Excellent knowledge of raw materials, production processes and quality control standards. Superb communication and organizational traits to predict troubles and delays.
Overview
12
12
years of professional experience
Work History
Downstream Manufacturing Supervisor
Rentschler Biopharma INC.
10.2022 - Current
- Hands on supervision of manufacturing staff including hiring, coaching, training and goal setting, professional development, overall performance management and assessment.
- Maintain prosomal training requirements and assure that each team member is adequately trained.
- Schedules daily activities for the shift, track completion of activities and reports on progress to downstream manufacturing manager.
- Subject matter expert in cGMP downstream manufacturing: Chromatography, Column Packing, Tangential Flow Filtration, Nanofiltration, formulation, Bulk Drug Substance.
- SME expert in SAP and LIMS.
Supervisor Manufacturing
ReciBioPharm
02.2022 - 10.2022
- Train and supervise 3-4 staff.
- Led EMPQ execution.
- Led Microbiome and Central Support Service team.
- Author, revise, review and approve cGMP documentation (OJTs and SOPs).
- Approve timesheet and perform performance review.
- Responsible for staff and team performance.
- Ensure scheduling of production and maintenance activities.
- Perform periodic review of cGMP documentation to ensure accuracy.
- Initiate material onboarding form, order equipment and supplies from vendors.
- Efficient use of Veeva Vault.
Senior Manufacturing Associate, Acting Supervisor
Rocket Pharma
04.2020 - 02.2022
- Led equipment FAT, SAT, and facility start-up.
- Led EMPQ execution.
- Authored, revised, reviewed, and approved cGMP documentation (batch records and SOPs).
- Trained and mentored staff. Assist in the development of staff process knowledge.
- Experience with Manufacturing processes include but are not limited to cell line initiation (vial thaw), cell line scale-up, bioreactor operations, transfection, harvest clarification, TFF, column packing, chromatography, and bulk drug substance fill.
- Perform periodic review of cGMP documentation to ensure accuracy. Accurately complete and compile official documentation per Rocket Good Documentation Practices (GDP) requirements.
- Cross-trained on Upstream process.
Senior Manufacturing Technician
Erytech Pharma, INC
08.2019 - 03.2020
- Worked with Red Blood Cells Product.
- Reviewed logbooks and Batch Records.
- Able to demonstrate and apply good aseptic technique and cleanroom behavior.
- Good gowning technique during certification, re-certification, and routine monitoring.
- Ability to monitor all environmental parameters, such as viable and non-viable sampling, personnel sampling, and utilities following laboratory and company guidelines.
- Perform required sampling utilizing contact plates, settling plates, RCS strips, and particle counters.
- Perform environmental monitoring testing and utility sampling and testing on scheduled days.
- Use of COBE and Erycaps machine.
Lead Manufacturing Technician/Process Development
Outlook Therapeutics, INC
09.2018 - 08.2019
- Supervised and managed employees.
- Revised SOPs, reviewed batch records and logbooks.
- Performed daily weight check for raw material weighing and Dispensary.
- Raw material sampling and Buffer preparation.
- Protein purification process using buffer solutions, chromatography, viral filtration and concentration/diafiltration.
- Used AKTA Avant in Process Development Lab for process characterization and optimization projects.
- Good use of AKTAprocess skid for running process, sanitizing, WFI rinse and storage.
- Good use of Millipore viresolve, depth filter, pH/Conductivity meter, Cubical Palletanks and Mixtainers.
- SoloVPE SME.
- Filled Bulk Drug Substance Aseptically.
Senior Manufacturing Technologist
Immunomedics, INC
05.2018 - 08.2018
- Manufactured antibodies, antibody fragments and conjugates.
- Purified antibodies using ion-exchange, affinity column chromatography, and DV20 Virus Removal Filtration.
- Maintained accurate batch records, logbooks, and log sheets.
- Authored and revised batch records, buffer sheets, SOPs, and Material Specification Sheets (MSSs).
- Performed bulk drug substance.
- Monitored and assured adequate supply of glassware/components for manufacturing.
Senior Biologics Operator, Active Team Lead
Bristol Myers Squibb
01.2012 - 02.2018
- Distributed assignments, reviewed batch records and logbooks.
- Maintained good practice of standard of operation, gowning, and cGMP manufacturing regulations.
- Yellow Belt certified and STOP certified.
- Experience with Trackwise, Delta V computer, AKTAprocess skid, high performance liquid chromatography, Fill Aseptic and Environmental Monitoring.
- Performed buffer preparation, batch processing and sampling products.
- Efficient use of conductivity, pH, and osmolality meters.
- Product changeover of equipment.
- Performed CIP and SIP buffer vessel, transfer lines and product tanks.
- Performed phosphoric derouging, passivation and integrity filter testing.
- Gold particle solution testing of including planova.
- Good use of Ultrafiltration, millipore viresolve and depth filter.
- Operated parts washer and Autoclave.
- Performed column conditioning, sanitization, WFI rinse and storage.
- TOC Miscellaneous parts, system suitability & daily verification, total organic carbon analyzer.
- Hot-Lips tube sealer, spectrophotometer, and SoloVPE expert.
- LIMS and SAP.
- Maintenance, 5S.
Education
Bachelor of Science - Respiratory Therapy
SUNY Upstate Medical University
Syracuse, NYBachelor of Science - Biology
SUNY College At Oswego
Oswego, NYSkills
Leadership skills:
- Maintained Merit or Honor Roll status throughout high school
- African Student Union President at SUNY Oswego
- Served as a school president on student government in Ghana
- Taught Respiratory Care freshman laboratory clinical
Timeline
Downstream Manufacturing Supervisor
Rentschler Biopharma INC.
10.2022 - Current
Supervisor Manufacturing
ReciBioPharm
02.2022 - 10.2022
Senior Manufacturing Associate, Acting Supervisor
Rocket Pharma
04.2020 - 02.2022
Senior Manufacturing Technician
Erytech Pharma, INC
08.2019 - 03.2020
Lead Manufacturing Technician/Process Development
Outlook Therapeutics, INC
09.2018 - 08.2019
Senior Manufacturing Technologist
Immunomedics, INC
05.2018 - 08.2018
Senior Biologics Operator, Active Team Lead
Bristol Myers Squibb
01.2012 - 02.2018
Bachelor of Science - Respiratory Therapy
SUNY Upstate Medical University
Bachelor of Science - Biology
SUNY College At Oswego
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