Santhoshkumar.N
Summary
- Experienced cGMP Upstream Manufacturing (Mammalian cell Culture) Professional.
- Batch readiness (COP, CIP, PHT and ESIP) and Media and solutions preparation.
- Good knowledge qualification activities IQ,OQ,PQ.
- Collaborating with multidisciplinary teams, including chemists, engineers, and business professionals, to develop scalable processes for New products.
- Prepare and execute protocols for SIP validation and cleaning validation.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Experienced CGMP Upstream Manufacturing (Mammalian Cell Culture) Professional
Lupin Limited (Biotech Division)
12.2020 - Current
- Working in the upstream processing of monoclonal antibodies from CHO cells
- Planning and carrying out daily batch activities; monitoring and maintaining process key parameters (pH, DO2, and temperature)
- Contributes in Batch startup activities to harvest activities (Vial to Flask, Glass bioreactor to SS Bioreactor and SS Bioreactor to 1KL Single use bioreactor)
- Developing and implementing protocols for quality control and quality assurance during bio manufacturing processes
- Responsible for leading a shift, for batch execution
- Actively involved in PPQ batches EMA batches of Etanercept
- Knowledge of process troubleshooting and critical parameters
- Writing reports, and reviews for regulatory documents, and BPR
- Scaling up laboratory processes for industrial production, including troubleshooting issues during scale-up and transfer to manufacturing.
- BPR and Log-book review status updating.
- Maintain Quality System as per cGMP Norms and Coordinating with QA.
- Responsible for preparation of GDP and cGMP related documents & shop floor area readiness for audits (External & Internal).
Education
Master of Science in Biotechnology -
M.G.R college of Arts and Science, Hosur, Tamilnadu
01.2017
Bachelor of Science in Biotechnology -
M.G.R college of Arts and Science, Hosur, Tamilnadu
01.2015
Technical Skills
- Preparation of equipment operating procedure (EOP) and SOP.
- Assisted in the compilation of qualifying documents, such as the Traceability Matrix and SLIA.
- Responsible for the creation GxP documentation preparation such as GxP Assessment, EDC check list and in-house protocol of IOPQ.
- Operation of SS & Single use Bioreactors.
- Media and Solution preparation & their filtration.
Equipment Qualification Activities
- Performed in equipment qualification such as IQ, OQ, PQ for Magnetic stirrer, Overhead stirrer, Filter integrity, MVP system, Bio welder, Bio sealer as well as Area qualification activity.
- Contributes in PQ qualification for 75L and 500L SS Bioreactors and steam sterilizer.
- Participates in CSV Validation.
- Assisted in the compilation of qualifying documents, such as the Traceability Matrix and SLIA.
- Responsible for the creation GxP documentation preparation such as GxP Assessment, EDC check list and in-house protocol of IOPQ.
Affiliations
- Caliber Electronic- Log (E-Log) “Online Equipment Usage Entries”
- Electronic Document Management System (EDMS) “SOP/EOP Preparation and Document issuance”
- Learning Management System (LMS) “Training of cGMP Documents”
- Batch related Material and consumable maintenance trough SAP.
KEY STRENGTHS
- Supervising and training technical staff, students, and interns in the laboratory.
- Quick Learner, easily adaptable to new environment
- Sincere, Confident & Helpful along with Leadership skills
- Ability to carry out multitasks and meet targets.
Certification
- Bioreactor operation in Nibrt and Cytiva.
- Bio welder TC operator Training in Sartorius
Accomplishments
"Bravo! Value Ambassador" certification of appreciation received 2 times from current organization.
Personal Information
- Date of Birth: 03/23/94
- Gender: Male
- Nationality: Indian
Languages
Tamil
First Language
English
Intermediate (B1)
B1
Kannada
Intermediate (B1)
B1
Hindi
Beginner (A1)
A1
Telugu
Intermediate (B1)
B1
Timeline
Experienced CGMP Upstream Manufacturing (Mammalian Cell Culture) Professional
Lupin Limited (Biotech Division)
12.2020 - Current
Master of Science in Biotechnology -
M.G.R college of Arts and Science, Hosur, Tamilnadu
Bachelor of Science in Biotechnology -
M.G.R college of Arts and Science, Hosur, Tamilnadu
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