Tejal Naik
MSAT expertise
Thane
Summary
Results-driven MSAT professional with 8+ years of experience in biopharmaceutical manufacturing, downstream (DS) process development, technology transfer, process validation (PV), continued process verification (CPV), and process performance qualification (PPQ). Expertise in scale-up strategies from 20L to 200L, yield optimization, chromatography, filtration, microbial fermentation, protein refolding, market complaint investigations, quality management systems (QMS), and computer system validation (CSV). Adept at risk assessments and ensuring regulatory compliance in biotechnology and pharmaceutical manufacturing.
Overview
10
10
years of professional experience
Work History
Senior Executive – MSAT
Enzene Biosciences Ltd.
Pune
12.2023 - Current
- Led scale-up from 20L to 200L with focus on yield improvement and process optimization
- Conducted Nitrosamine Risk Assessment, ensuring adherence to industry and regulatory guidelines
- Spearheaded process performance qualification (PPQ) and continued process verification (CPV)
- Investigated and resolved market complaints, conducting root cause analysis and implementing corrective actions
- Authored and reviewed scale-up documents, validation protocols, and hold-time studies
- Supported regulatory audits and provided technical expertise for compliance with GMP requirements
- Assisted in chromatography optimization, buffer preparation, and filtration troubleshooting
- Worked on risk assessment documentation, PPQ strategies, and hold-time validation studies
Business Sales Manager
Diana Advanced Tech Academy
Bangalore
07.2023 - 11.2023
- Developed strategic sales initiatives to increase revenue and market reach
- Led client engagements, negotiated contracts, and built strong customer relationships
Senior Executive – Manufacturing Operations
Biocon Biologics India Ltd.
Bangalore
05.2021 - 02.2023
- Ensured compliance with quality management systems (QMS) and executed change management, CAPA, risk assessments, and deviation investigations
- Led process improvements and troubleshooting in upstream and downstream processing for monoclonal antibody production
- Reviewed executed batch manufacturing records (BMRs) and validation documents
Senior Executive – Manufacturing (Microbial)
Reliance Life Sciences
Mumbai
08.2016 - 10.2020
- Led end-to-end manufacturing operations for microbial fermentation, protein refolding, and purification processes
- Served as Shift In-Charge, ensuring smooth execution of manufacturing batches while maintaining compliance with GMP standards
- Designed and implemented batch records in Werum PasX MES for process optimization and automation
- Conducted cleaning validation, process validation, and QMS activities to maintain regulatory compliance
- Acted as a Subject Matter Expert (SME) during regulatory inspections and audits, including USFDA, EMA, MHRA, WHO, and CDSCO
- Worked on chromatography, ultrafiltration, and buffer preparation for downstream process optimization
- Developed scale-up strategies from lab-scale to commercial scale, ensuring process robustness and reproducibility
Marketing Intern
Sanika Pharmaceuticals
Navi Mumbai
03.2015 - 08.2015
- Conducted market research, developed promotional strategies, and provided customer support
Education
PG Diploma - Biotherapeutics
01.2016
B.Tech - Bioinformatics
H.S.C - Science
S.S.C - Science
Skills
- Process Development
- Process validation
- Chromatography techniques
- Regulatory compliance
- Cross-functional collaboration
- Technology transfer
- Continued Process Improvement
- Upstream processing
- Quality & Compliance
- Market Complaint Investigations
- Computer System Validation
- MES
- Pharma Suite
- PasX Werum
- Track Wise
- SAP
- Protein Purification
- Process Optimization
- Yield Improvement Strategies
Professional Attributes
- Strong leadership and cross-functional collaboration skills.
- Proven ability to troubleshoot and optimize biopharmaceutical manufacturing processes.
- Detail-oriented with excellent documentation and regulatory compliance expertise.
- Adaptable, proactive, and result-oriented approach to problem-solving.
Personal Information
Title: Senior Executive – Manufacturing Sciences and Technology (MSAT)
Regulatory And Audit Exposure
USFDA, EMA, MHRA, WHO, CDSCO, INVIMA, INVIZA, Turkey MOH, Iran MOH, Successfully led manufacturing site inspections and regulatory reviews.
Certifications And Skills
- Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP)
- Regulatory Audit Preparedness & Compliance
- MES (Werum PasX, PharmaSuite), TrackWise QMS, SAP, LIMS, EDMS
- Process Validation, Cleaning Validation, and Hold Time Studies
- Risk Assessments including Nitrosamine Risk Assessment
- Root Cause Analysis & CAPA Implementation
- Market Complaint Investigations & Troubleshooting
- Chromatography (Affinity, Ion Exchange, Size Exclusion), TFF, Ultrafiltration
- Buffer Preparation, Depth Filtration, and Protein Purification
- Scale-Up & Process Optimization from 20L to 200L
- Yield Improvement Strategies & Process Intensification
Languages
English
First Language
Hindi
Upper Intermediate
B2
Marathi
Upper Intermediate
B2
Timeline
Senior Executive – MSAT - Enzene Biosciences Ltd.
12.2023 - Current
Business Sales Manager - Diana Advanced Tech Academy
07.2023 - 11.2023
Senior Executive – Manufacturing Operations - Biocon Biologics India Ltd.
05.2021 - 02.2023
Senior Executive – Manufacturing (Microbial) - Reliance Life Sciences
08.2016 - 10.2020
Marketing Intern - Sanika Pharmaceuticals
03.2015 - 08.2015
Reliance Institute of Life Sciences - PG Diploma, Biotherapeutics
Padmashree Dr. D.Y. Patil University - B.Tech, Bioinformatics
St. Joseph’s Junior College - H.S.C, Science
St. Joseph’s High School - S.S.C, Science
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