Apurva Bapat
Manufacturing Operations Specialist
Stoneham,MA
Summary
A results-driven biotech professional with experience in manufacturing operations. Expertise includes change control, root cause investigation (RCI), and managing Corrective and Preventive Actions (CAPA) within a cGMP environment. Proven ability to lead cross-functional teams, troubleshoot complex issues, and author quality documentation, including non-conformance reports (NCRs), to ensure product quality and regulatory compliance. Ability to work in a fast-paced setting.
Overview
2025
2025
years of professional experience
Work History
Scientist II (Quality Control)
Akoya Biosciences
2023.10 - 2024.07
- A key contributor in a multi-disciplinary team executing batch testing and product improvement activities with focus on testing multiplex fluorescent immunohistochemistry (IHC) assays. Introduced improvements in QC workflow and troubleshooting to grow Akoya’s set of commercial products.
- Collaborated with key stakeholders (R&D, Product Management, Quality Assurance and other SMEs) to maintain supply-chain of immune-histochemistry based products: supported activities to increase sales from 35% to 98% of target annual goal.
- Steered multifunctional meetings to keep the CAPAs on track by providing valuable feedback and initiating critical discussions where needed: Prevented immature closure of a critical CAPA and initiated a new CAPA to simplify process improvement activities.
- Authored NCs to document OOS and OOT results for saleable products: Solely responsible for capturing all final QC testing related non-conformances. Experience with Arena.
- In-process and release testing (final QC) as needed by supporting lab chemists. Presented and discussed results, collaborated with R&D and Product Managers to troubleshoot failed results.
- Helped set-up QC department in the Marlborough MFG facility: Introduced and revised procedures, specification documents to ensure cGMP and GDP. Experience with NetSuite.
- Supported Reagent Manufacturing by performing antibody conjugation, HPLC analysis, BCA assay when needed.
Sr. Biomedical Engineering Scientist (R&D)
Siemens Healthineers
2015.06 - 2023.02
- An SME in a multi-disciplinary team working Service, Manufacturing, and Quality to investigate and drive corrective actions in response to field issues. Resolved manufacturing obsolescence and manufacturing quality issues, lead design change projects aimed at improving product quality and reliability.
- Investigated escalated issues related to product performance to resolve customer complaints for blood gas assays and cardiac assays.
- Designed and conducted experiments to assess product performance, shelf-life and reliability: Supported shelf-life extension of a critical part for Stratus CS. Worked on sunset projects for cardiac assays.
- Analyzed data and authored technical reports to support product investigations and feasibility testing.
Sr Supervisor (Technical Operations)
- Technical Leader responsible for maintaining supply-chain of Thyroid immunoassay-based products. Lead a team of 5 individual contributors to manage change projects, CAPAs, investigations, non-conformance reports, lab testing of Thyroid immunoassay-based products. Operations SME in multi-functional team meetings to support Tech Transfer activities.
- Designed and conducted experiments to troubleshoot reagent manufacturing issues resulting in substantial savings.
- Managed process and design change projects to improve control system of immunoassays.
- Authored technical reports to document characterization and verification/validation studies. Worked on FMEAs.
- Skillfully lead cross-functional teams to work on Customer Communications.
- Authored quality notifications (supported shop-floor activities), managed CAPAs and IRs
- As an operations SME, provided technical support to functions such as QC, QA, filling and lyophilization as needed.
- Attended managerial and employee meetings, receiving updates on products and services, and providing feedback to employees. Led new hires through company onboarding procedures, training and instructing on demands of various positions and instilling company values.
- Experience working with SAP-PLM, Documentum, CATSWeb.
Biochemist (Technical Operations)
- Responsible for ensuring continuous supply of critical raw materials (secondary antibodies) for immunoassays. Supported Manufacturing by conducting investigations of NCs and authoring NCRs.
- Lead design change projects to revise control system of infectious disease immunoassays on the ADVIA Centaur Systems.
- Purified anti-human goat antibodies using affinity chromatography to generate 5-year supply for the manufacture of an immunoassay.
- Worked as a liaison between Technical Operations and Manufacturing to troubleshoot manufacturing lots in process and work instructions.
- Conducted stability testing to determine shelf-life of internal controls.
Lab Assistant II (Technical Operations)
- Worked with human serum, plasma and urine-based samples and performed clinical diagnostic-based immunoassays on ADVIA Centaur Systems.
- Assisted in purification of proteins as a part of Critical Raw Materials group.
- Maintained batch records and worked on documentation per FDA requirements.
Research Assistant
BWH-Harvard Medical School
2014.11 - 2015.05
- Worked on prostate and lung cancer cell lines for RNAi technology-based nanomedicine development, targeting drug-resistant cancer. Learnt how to make LNPs with siRNA cargo using manual mixing.
- Analyzed effects of Paclitaxel on drug-resistant and non-resistant cancer cell lines using fluorescence-based and other cell viability assays.
- Performed target validation experiments to identify drug resistance-conferring genes.
Education
Master of Science - Biotechnology
New York University
New York, NY2014-06
Bachelor of Technology - Biotechnology
University of Pune
Pune, Maharashtra2012-06
Skills
Ø Cross-Functional Collaboration – Leading multi-functional team meetings, transparent and effective communication, accountability
Ø Change Control Process – Design and process change projects, regular attendance in CRB meetings
Ø Quality Management System – ISO 9001:2015, ISO 13485:2016
Ø cGMP and GDP – Manufacture, testing and release of saleable products adhering to International Quality Standard
Ø Quality Records and CAPA System – Excellent knowledge of management and implementation of Corrections, Corrective Actions and Preventive Actions Trained in writing and reviewing NCRs, identifying deviations from approved procedures
Timeline
Scientist II (Quality Control)
Akoya Biosciences
2023.10 - 2024.07
Sr. Biomedical Engineering Scientist (R&D)
Siemens Healthineers
2015.06 - 2023.02
Research Assistant
BWH-Harvard Medical School
2014.11 - 2015.05
Biochemist (Technical Operations)
Lab Assistant II (Technical Operations)
Sr Supervisor (Technical Operations)
Master of Science - Biotechnology
New York University
Bachelor of Technology - Biotechnology
University of Pune