SOLOMON T. DEBEBE
Methuen,USA
Summary
Principal Associate with over 18 years of experience in the Biotech industry, skilled in performing a wide range of manufacturing activities related to Upstream/ Downstream. Highly organized, self-directed, dedicated to executing and delivering positive results independently or as a team member. Adaptable, able to prioritize and multi-task in a fast-paced environment. Team player, patient, respectful of differences, great trainer, and recognized as an outstanding employee by superiors. Seeking a Lead/ Senior position in Upstream/ Downstream Process Operations.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Manufacturing Principal Associate
Seres Therapeutics
Cambridge, MA
12.2020 - 03.2026
- Lead and performing on floor activity
- Author s standard operating procedures, Batch records and Deviations
- Participate in Investigations and quality events
- Performing batch records, logging equipment
- Performing drug substance and drug product
- Prep Media culture and Solution
- Performing Fermented Products
- . Performing the OJT reviewer.
- . Follow and Complete daily standard operation procedures by completing reports
- . Reviewing Manufacturing documentation to ensure compliance.
Manufacturing Lead Associate
Thermo Fisher Scientific
Cambridge
03.2019 - 03.2026
- Proficient in Adherent and Suspension cells Thaw and Expansion/ Passaging using Shaker flask and T-flask, Hyper stacks, CS1s, CS2s, CS5s and CS10s.
- Installation and Inoculation of XRS, STRs, and bioreactors for cell expansion.
- Operation and Maintenance of several equipment which includes: VI-Cell, BGA, pH meters, Osmometers, Tabletop, analytical and floor scales, Autoclaves.
- Aseptically Media, Triple, PBS and all other Aseptic Aliquots in BSC (Bio Safety Cabinet).
- Experienced in EM (Environmental Monitoring) after any Activities carried out in BSCs using Clement Counter 150ct and Lasar.
- Daily Sampling of cells for Viable Cells Density and Viability using VI-Cell and BGA to monitor cell growth.
- Trainer for various small equipment daily maintenance and monthly PMS and these include: BSC (Bio safety Cabinet) Stringent, Pre-use, post-use cleaning, VI-Cell, BGA, pH, Conductivity meters and Osmometers. Accuracy checks on Tabletop, analytical, and floor scales.
- Trainer on Aseptic Qualification and Requalification.
- Well, equipped with Akta ready preparation and Method runs for AVB, AEX, Downstream processes.
- Experienced with Spectrum UF/DF skid preparation and operation.
- Experienced with TFF, and BDS bottling.
- Pall allegro MVP single use system
- Pall ICELLIS 5001.0 single use Bioreactor and iCellis 2.0 single use Fixed-Bed Bioreactor
Manufacturing Associate IV
BrammerBio
Cambridge, MA
01.2017 - 03.2019
- . Performed Cell expansion and adhere cell
- . Performed Cell stack, hyper stack, centrifuge, Cell passaging, VI cells, Thaw
- . Generate and execute work orders.
- Performed Upstream and Downstream operation
- . Standardizing, preparation and inoculation of ready to process WAVE 25 cell bags using E-logs, UNICORN system.
- Sample testing for cell density and viability, CO2, O2, and pH of inoculated cell bags and bioreactors using CEDEX, BGA, and pH meter/machines.
- Pre-use filter integrity Testing of 0.1μm post media filter, installation, pressure test and SIP of 0.2μm (pre-filtration filter) and 0.1μm (post-filtration filter).
- CIP, Pressure Test, SIP of media line for refeed of inoculated bioreactors.
- Automated execution of all buffer prep activities using Syncade and Delta V system (buffer mixes, CIPs, SIPs, transfers, Charging and Dispensing of components, transfer of buffers from bags to stock tanks.
- Proficient in Buffer pH and conductivity Adjustments/Titrations using 8N, 10N NaOH, HCL, and WFI.
- Initiation of new orders/recipes to buffer prep tanks and buffer Hold tanks using Syncade and Delta V.
- Attained training on STOP Observers and Yellow Belt.
- Filter Integrity testing filters after solution transfer when required by Batch Record.
- Led Quarterly Cleaning of Buffer/ Purification suits and reported any discrepancies encountered during operations.
- Experienced in operating various equipment CM 150 TF single use system, Pall allegro MVP single use system, AKTA ready flow Kit liquid
Manufacturing Associate IV
Biogen
Cambridge, MA
06.2014 - 12.2016
- Reviewing Logbook, Forms and Batch record
- Use of E-logs to Standardize pH meters, Conductivity meters, scale tests and Osmometer
- Performed Pre and Post use CIP and Transfer Lines
- Performed Process recipe, Equilibration, Load, Wash, and Elution
- Prepared for media transfers to cell culture and vessel preparation for CIP.
- Responsible for Receipt and confirmation of raw materials in Media prep area.
- Responsible for monthly Inventory of raw materials used in media prep area.
- Takes initiative of preparing equipment and materials for the oncoming shift.
- Solely responsible for the introduction of safe storage and transportation of dirty mixing blades from dirty glass to cleaning stations.
- Responsible for introducing safe carts for moving 3 to 6 (10KG) weights to and from weighing scales in both Buffer and Media weigh and dispense rooms.
- Upstream Operations:
- Standardizing, preparation and inoculation of ready to process WAVE 25 cell bags using E-logs, UNICORN system.
- Sample testing for cell density and viability, CO2, O2, and pH of inoculated cell bags and bioreactors using CEDEX, BGA, and pH meter/machines.
- Pre-use filter integrity Testing of 0.1μm post media filter, installation, pressure test and SIP of 0.2μm (pre-filtration filter) and 0.1μm (post-filtration filter).
- CIP, Pressure Test, SIP of media line for refeed of inoculated bioreactors.
- Proficient in running CIPs on Buffer tanks and Transfer lines.
- SIP for filters and transfer lines.
- Buffer tank preparations which include online pH and conductivity probes standardization.
- Standardization of offline pH and Conductivity Probes.
- Automated execution of all buffer prep activities using Syncade and Delta V system (buffer mixes, CIPs, SIPs, transfers, Charging and Dispensing of components, transfer of buffers from bags to stock tanks.
- Proficient in Buffer pH and conductivity Adjustments/Titrations using 8N, 10N NaOH, HCL, and WFI.
- Initiation of new orders/recipes to buffer prep tanks and buffer Hold tanks using Syncade and Delta V.
- Attained training on STOP Observers and Yellow Belt.
- Filter Integrity testing filters after solution transfer when required by Batch Record.
- Led Quarterly Cleaning of Buffer/ Purification suits and reported any discrepancies encountered during operations.
- Experienced in operating various equipment (stain steel tanks, Glass washer, COP washer, Autoclave, Hoist).
Manufacturing Associate III
Biogen
Somerville/Cambridge, MA
06.2011 - 06.2014
- Solely responsible for Monthly and Quarterly PMs for all equipment in the material Warehouse. Resulted in proper functioning of equipment, good hygiene, durability, and extended life of the equipment.
- As PMs, SME, I proactively submitted work orders when equipment broke down and completed monthly/ yearly PMs
- Experienced with label and Pack operations (Label printing for clinical finished drug products, check weigher, tamper seal, and automated label applicator).
- Requested, confirmed delivery of, and then tracked data on the use of raw materials, using the Oracle (OPM) system.
- Tracked completion of printing and drug packing operations during post-production.
- Relied upon as a Peer trainer for use of equipment and Process understanding.
- Performed (AWD) Automatic weighed and dispense
- Trained Daily documentation review of production records and associated cGMP paperwork prior to final quality assurance review.
Manufacturing Associate II
Biogen
06.2008 - 07.2011
- Relied upon as Acting Lead Associate in the absence of formal Supervisors.
- Proficient in the assembly of various process equipment (Bio process bags, Bottling apps, portable and In-place product tanks and Inocans).
- Improved process of classifying expired components/ chemicals with proper labeling and handling during disposal process.
- Awarded for “Living the Values” and Teaming and Leading” for behaviors that prevent lost time and higher cost like observing critical near misses.
- Experienced with small instruments utilized in purification analysis (Osmometer, pH meter, Conductivity meter, Spectrophotometer, and Kinetic Reader).
- Experienced with Media/Buffer preparation, pressure testing of various large and small equipment.
- Performed Data entry for released SLRs using Discoverant and Daily Logbook for review and maintenance.
- Experienced with various equipment Interfaces for Buffer/ Purification processes (Delta V, Syncade)
- Perform all aspect of dispensary process including but not limited
- Proficient in using various manufacturing scale equipment (Buffer tanks, IP, Glasswasher, COP washer Carboy washer, Autoclave and Purification Skids.
- Assembly of tanks, Pressure test
- Mixing insulin, Nutrient feed and Molar Base
- Followed proper Application of cGMP and Safety requirements for all activities
Education
Certificate - Cell Culture/Purification, Fundamentals of Bio Manufacturing
Worcester Polytechnic Institute
Worcester, MA01-2014
Certificate - biomedical laboratory and clinical sciences
Boston University Metropolitan College and School of Medicine Boston M City Lab Academy
Boston, M01-2008
Skills
- Customer service
- Time management
- Attention to detail
- Computer skills
- Process improvement
- Workplace safety
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Documented and resolved [Issue] which led to [Results].
Certification
- [Area of expertise] License - [Timeframe]
Languages
Amharic
Full Professional
Swahili(Kiswahili)
Full Professional
Timeline
Manufacturing Principal Associate
Seres Therapeutics
12.2020 - 03.2026
Manufacturing Lead Associate
Thermo Fisher Scientific
03.2019 - 03.2026
Manufacturing Associate IV
BrammerBio
01.2017 - 03.2019
Manufacturing Associate IV
Biogen
06.2014 - 12.2016
Manufacturing Associate III
Biogen
06.2011 - 06.2014
Manufacturing Associate II
Biogen
06.2008 - 07.2011
Certificate - biomedical laboratory and clinical sciences
Boston University Metropolitan College and School of Medicine Boston M City Lab Academy
Certificate - Cell Culture/Purification, Fundamentals of Bio Manufacturing
Worcester Polytechnic Institute
BIOGEN TRAINING
- TOC swab Certification, ESL English Certification, QA training on updating Technical Reports, Exporting PDFs in myCims, and initiating and writing investigations in Track wise.
- Training on Human Performance tools that have contributed to effective execution of my job assignments successfully with minor or no major errors/ deviations.
Employee of the year
I was selected employee of the year in 2010 from my department while working Biogen