Quality Control Biological Science

Michael Muganga K

Immediately Available

A Crew

Recruiters Summary:

•Mr. Michael has 5+ years of experience in laboratory operations, including bioassay testing, quality control, and drug manufacturing/biopharmaceutical development

•He holds an Bachelor's degree in Biological Science

•Proficient in technical lab skills like pipetting, analytical balances, pH meters, and liquid handling

•Skilled in media preparation, with expertise in buffer/media manufacturing for experimental applications

•Strong knowledge of GLP/GMP standards with 4+ years of compliance expertise

•Proficient in data documentation using electronic lab notebooks for accurate, compliant record-keeping and reporting

Professional Summary:

•Experienced Life Sciences Professional with 5+ years in laboratory operations including bioassay testing, bioassay testing, and quality control, specializing in drug manufacturing and biopharmaceutical development.

•Hold a Bachelor’s degree in Biological Science.

•Proficient in Technical Lab Skills, including the use of pipettes, analytical balances, pH meters, and liquid handling, ensuring precise sample preparation, media formulation, and testing.

•Skilled in Media Preparation, with hands-on experience in buffer/media manufacturing, for experimental applications.

•Strong Knowledge of GLP/GMP Standards, with 4+ years of expertise in maintaining compliance, ensuring data integrity, and conducting routine testing in regulated environments.

•Proficient in Data Documentation using electronic lab notebooks to ensure real-time, accurate, and compliant data entry, record-keeping, and reporting.

Skills

Experience

Lab Environment

4+years

Technical Lab skills (pipettes, analytical balances, pH meter)

4+years

Electronic notebooks (Athena, LIMS)

3+years

media preparation, cell maintenance/passaging

4+years

Inventory Management and ordering

4+years

Instrument maintenance and calibration

4+years

GLP/GMP

5+years

Education:

Bachelors in Biological Science 2010-2012

Kyambogo University, Uganda

Diploma in Science Technology (Biology) 2007-2009

Kyambogo University, Uganda

Certificate in Science laboratory& Technology 2004-2006

Professional Experience:

Sanofi, Framingham, MA July 2023 – Oct 2024

Manufacturing lab Associate

•Responsible for ensuring that set quality parameters are maintained during processing.

•Efficiently produced bulk Hyaluronic Acid by strictly following the batch records, ensuring compliance, data integrity, and executing ERP transactions (Athena).

•Troubleshoot process problems, participating in deviation root cause analysis, assists in validation activities and process improvements ensuring that manufacturing records are correctly documented, and monitoring and reporting safety concerns.

•Ensured QC of media and reagents used in the production of Hyaluronic Acid (HA), performing routine sterility and contamination checks, verifying ingredients against batch records, and ensuring compliance with cGMP guidelines.

•Used pipettes for accurate liquid handling in the preparation of reagents, buffers, and media for the fermentation and purification processes of Hyaluronic Acid (HA).

•Ensured effective and efficient operation of plant equipment to produce optimal quality and quantity of HA through fermentation and purification.

•Effectively communicated with the production team to ensure quality and safety is maintained.

•Followed the process standard operating procedures in the clean room cGMP environment with strict gowning requirements.

•Performed routine equipment CIP, SIP, visual inspections, and area cleaning procedures.

Azzur (Clean Room on Demand), Framingham, MA Nov 2022 – Apr 2023

Manufacturing Lab Technician

•Conducted analytical testing, including cell-based assays and ELISA, to assess batch-to-batch consistency and support product release, ensuring the biopharmaceuticals met required specifications

•Used aseptic techniques and environmental monitoring, ensuring the absence of microbial contamination and maintaining cGMP compliance throughout the manufacturing process.

•Received standard laboratory materials and initiate the appropriate quality control testing,

•Used electronic notebooks (GxP) to document test results and media preparations, ensuring compliance and maintaining audit-ready records for QC testing and sample handling

•Prepared media and reagents, and performed laboratory testing in compliance with ISO/IEC 17025,

•Set-up tests using aseptic technique according to protocols specifications and directives,

•Regularly calibrated pipettes as part of routine equipment maintenance to ensure precise and reproducible sample measurements in compliance with cGMP standards.

•Log in samples; assigning sample report ID number; create labels acquire laboratory forms or requisitions; store samples for subsequent processing, and engaged in ongoing cGMP, safety and ethics programs,

•Environmental Monitoring: Involved in the sampling, processing, logging and analyzing as well as writing reports. Quality control of the received materials before dispatched to the respective departments

•Product and Cleanroom QC: EM, sterility on raw materials and finished product. ISO-5 Environmental monitoring. Proficient in full ISO-5 gowning and personnel monitoring.

•Worked in aseptic environment using laboratory equipment, pH meter, balances, maintained incubation, media transfer, CIP, SIP, and centrifuge harvesting.

•Performed QC testing on media used for bioassays, ensuring correct composition and sterility to support regulatory requirements for safety and efficacy studies.

•Performed quality control (QC) checks on buffer and media formulations, ensuring all ingredients met required specifications and were free from contaminants before use in experiments.

•Trained in Pre-CIP of tanks, skid and portable tank filter and pressure value testing, and assisted in production processes utilizing SAP, completed daily CIP and SIP and filling drug product tanks.

Charles River Laboratories International Mar 2022 – Oct 2022

Research Associate

•Conducted GLP and non-GLP in vivo safety assessments, including test substance administration to animal models, ensuring proper procedure and adherence to safety protocols.

•Collected and recorded study data with minimal supervision, ensuring accuracy and integrity in compliance with both GLP standards and regulatory requirements.

•Performed QC testing on media used for bioassays, ensuring correct composition and sterility to support regulatory requirements for safety and efficacy studies.

•Performed precise pipetting for sample preparation in bioassays and bioanalytical testing, ensuring accurate volumes for cell culture, reagent mixing, and assay setups.

•Performed routine bioassay testing as part of quality control (QC) measures, evaluating the potency, activity, and stability of biologics to ensure adherence to regulatory and internal quality standards.

•Responsible for handling and restraining animals, clinical observations, and sample collections,

MRC/UVRI and LSHTM unit, Uganda Apr 2009 - Apr 2019

Laboratory Technologist

•Performed a range of virus culturing techniques (e.g., viral inhibition, neutralization, pseudovirus production, ELISPOT, and transfection) for various virology and immunology studies, including isolation of PBMCs for downstream applications.

•Developed and wrote standard operating procedures (SOPs) for laboratory techniques, providing training to junior staff on new methodologies and best practices to ensure quality and efficiency in lab operations.

•Managed specimen archiving and data entry into FreezerWorks/LIMS, ensuring proper tracking and documentation of all samples and ensuring compliance with regulatory requirements for sample handling and storage.

•Ensured that movement of specimen in and out of the archives is properly controlled and documented.

•Retrieved and prepared samples for local or international shipping and updated inventory list,

•Ensure that maintenance logs on all freezers are up to date and monitoring deviations,

•Documentation of storage, retrieval, shipping and any other documents relevant to bio repository activities, ensured equipment maintenance/servicing are executed.

Publication:

HIV-1 superinfection can occur in the presence of broadly neutralizing antibodies. JOURNAL OF VACCINE 2017

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