SIDHARTH BALAKRISHNAN
Dublin,Ireland
Summary
QC Bioassay Senior Analyst with 6+ years of experience in cGMP biopharmaceutical laboratories, specialising in cell-based assays and ELISA's for monoclonal antibodies and gene therapy products. Proven expertise in method troubleshooting, investigations (deviations, CAPA, RCA), and technical transfer. Strong track record supporting regulatory inspections (US-FDA) and driving continuous improvement initiatives. Experienced in mentoring analysts and providing technical guidance within QC teams.
Overview
8
8
years of professional experience
5
5
years of post-secondary education
Work history
QC Bioassay Senior Analyst
Viatris
Dublin, Ireland
2021.01 - 2026.04
- SME for bioassays; troubleshooting and technical support
- Demonstrated knowledge of a variety of Bioassays with specific modes of action, such as: Cell Based Binding,
Proliferation, ADCC and CDC and FRET. - Sound understanding, knowledge of regulatory FDA/EMEA requirements applicable to the biologics and the
pharmaceutical industry. - Participated in technical transfers and Method Validation
- Wrote and reviewed technical SOP's, compliant with GMP standards, ensuring stringent regulatory adherence and laboratory safety.
- Provided support in implementing CAPA's (Corrective and Preventive Actions), RCA (Root Cause Analysis),
QI's, Effectiveness Checks and Fish-Bone Diagrams for a quicker turnaround time in batch release.
QC Gene Therapy Analyst
Eurofins
2020.01 - 2021.01
- Executed QC testing for TCID50 assays, ddPCR, binding ELISA's, and AAV capsid titer quantification via Western blot using Sypro-Ruby staining.
- Authored protocols, SOPs, analytical worksheets, COA templates, and change requests for QC, R&D, and QA.
- Supported development of audit review checklists for laboratory instruments to enhance audit comprehensiveness.
QC Analyst
Reliance Life Sciences
2018.01 - 2019.01
- QC testing for drug substances: Protein A, Host Cell Protein (HCP) and HcDNA by ELISA and qPCR.
- Mediated Analytical Technical Transfer (bioassays) of various biosimilars such as Ranibizumab, Rituximab, Omalizumab
and Erythropoietin - working with cross-function teams such as R&D, QC and QA departments. - Gained expertise in a variety of cell based assays such as Cytotoxicity assays, Cell Proliferation Assays and Neutralization
Assays.
Education
MSc - Molecular Cell Biology
University College Cork
Cork 2019.09 - 2020.09
B.Tech - Biotechnology
SRM Institute of Science and Technology
2013.07 - 2017.07
Skills
- Biochemistry & Bioassays
ELISA (HCP, Protein A) Cell-based assays (ADCC, CDC, proliferation) Gel-based methods (SDS-PAGE, Western Blot) - Analytical Techniques
Flow Cytometry (FACS) Biacore (SPR) qPCR ddPCR
- Data & Systems
SoftMax Pro Minitab PLA (Parallel Line Analysis) LIMS TrackWise - Quality & Compliance
cGMP / GLP Deviations CAPA RCA Change Control Audit Support SOP Authoring Technical Agreements Quality Investigations Effectiveness Checks Fish-Bone Diagrams
Personal Information
- Work Permit: Stamp 4
- Visa status: Stamp 4
Languages
German
Fluent
English
Fluent
References
References available upon request.
Timeline
QC Bioassay Senior Analyst
Viatris
2021.01 - 2026.04
QC Gene Therapy Analyst
Eurofins
2020.01 - 2021.01
MSc - Molecular Cell Biology
University College Cork
2019.09 - 2020.09
QC Analyst
Reliance Life Sciences
2018.01 - 2019.01
B.Tech - Biotechnology
SRM Institute of Science and Technology
2013.07 - 2017.07