SIDHARTH BALAKRISHNAN
Dublin
Summary
A proactive and creative individual with 6 years of cross-discipline solid industrial experience in Biochemistry, Molecular Cell Biology and Biotechnology in a cGMP/cGLP setting. Holds significant expertise in Cell Assays, Cell Culture, SDS-PAGE, Western Blotting, Surface Plasmon Resonance (SPR), Immunohistochemistry (IHC), qPCR, rt-PCR and Bioassays. A focused, results oriented individual, who is flexible to work autonomously or in a team.
Overview
6
6
years of professional experience
Work History
BIOASSAY ANALYST
VIATRIS
12.2021 - Current
- Participated in technical transfers and Method Validation, liaising with an R&D team in an offshore biopharma company.
- Wrote and reviewed over 20 in depth and technical SOP’s, compliant with GMP standards, ensuring stringent regulatory adherence and laboratory safety.
- Assisted the Instrumentation team in the Qualification of instruments such as BD FACS, as well as Biacore T200 and other instruments in the Bioassay Laboratory
- Actively participated in a US-FDA audit for commissioning of three new methods for the Bioassay Laboratory. All three methods were commissioned, without any observations
- Coordinated activities such as approving/reviewing investigations, raising PO's, authoring quality agreements and/or creating/assessing change controls
- 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
- Application of Lean sigma 6s throughout the bioassay laboratory for seamless batch release, safety
- Appointed VMI (Vendor Management Inventory) Liaison officer- managing stock inventory, leading to a reduction in Testing downtime of over 40%
- Optimized a HER2 binding assay protocol from 44 tubes to 164 tubes leading to a quicker turnaround time for batch release with no compromise in cells or sample integrity.
- Executed critical troubleshooting for a variety of Bioassay methods and equipment- resolving unique issues and reducing downtime.
GENE THERAPY ANALYST
Eurofins Biopharma Product Testing
11.2020 - 12.2021
- Part of the Gene Therapy team involved with Gene Therapy Product Testing for Duchenne's Muscular Dystrophy
- Active Involvement in Technical Transfers and Method Validation, enhancing overall laboratory throughput and efficiency
- Quantification of Capsid AAV titer by SDS-PAGE (Sypro-Ruby staining) and ELISA
- Demonstrated knowledge of TCID50 assay and ddPCR.
- Independently authored protocols, SOP's and analytical worksheets, COA templates, change requests for QC, R&D and QA
- Assisted in the development of audit review checklist for all instruments in the laboratory, improving audit comprehensiveness.
- Took an active role in continuous improvement, identifying and driving improvement initiatives in line with the laboratory CI team
- Trained/Mentored new analysts on SDS-PAGE and TCID50 assay- leading to a swifter progression onto other techniques.
MOLECULAR CELL BIOLOGY ANALYST
RELIANCE LIFE SCIENCES
05.2018 - 10.2019
- Responsible for maintenance of various types of cell lines, cell culture, including cell line revival
- Impurity testing for drug substances: Protein A, Host Cell Protein (HCP)
- Mediated Technical Transfer (bioassays) of various biosimilars such as Ranibizumab, Omalizumab and Erythropoietin - working with both Research and Development (R&D) and Quality control (QC) and QA (Quality Assurance) departments
- Adept at a variety of potency assays such as Cytotoxicity assays, Cell Proliferation Assays and Neutralization Assays
- Participated as a member of the Bioassay Department in several audits- including the Indian FDA (Food and Drug Administration).
Education
Master of Science - Molecular Cell Biology And Bio-innovation
University College Cork
Cork, Ireland10.2020
Bachelor of Science - Biotechnology
SRM UNIVERSITY
Chennai07.2017
Skills
- FACS (Flow Assisted Cell Sorting)
- Plate Reader (Softmax Pro 7 software)
- PLA (Parallel Line Assay) - version 20 and 30
- QRT-PCR and ddPCR
- Biacore T200- Surface Plasmon Resonance
- Minitab
- LIMS (Laboratory Information Management System)
- DMS (Document Management System)
- Trackwise
- QMS (Quality Management System)
- Cell and Plate Based Bioassay
Accomplishments
- Selected and appointed representative for HSE (Health, Safety and Environment) from the quality control team - devised and implemented a training methodology for improved environment safety practices for the team.
- Helped organize various professional seminars within Reliance Life Sciences hosted by various heads of life sciences firms focused on the development of Monoclonal Antibodies.
- Robotics: Worked at school level with robotic components such as 'RCX' and 'NXT' and participated at the Indian Robotics Olympiad.
- Earned a spot at the IRO (Indian Robotics Olympiad) and was part of a team of students to present their robotics design to renowned astronaut Sunita Williams at Vasant Valley School, New Delhi.
- Raised 300 euros through a cancer relay awareness as part of the UCC Cancer Society on March 2020.
Languages
English
Native language
German
Intermediate
B1
Timeline
BIOASSAY ANALYST
VIATRIS
12.2021 - Current
GENE THERAPY ANALYST
Eurofins Biopharma Product Testing
11.2020 - 12.2021
MOLECULAR CELL BIOLOGY ANALYST
RELIANCE LIFE SCIENCES
05.2018 - 10.2019
Master of Science - Molecular Cell Biology And Bio-innovation
University College Cork
Bachelor of Science - Biotechnology
SRM UNIVERSITY
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