Tejal Naik
Experienced MSAT expert in Drug substance (DS) manufacturing
Thane
Summary
Results-driven professional with 8+ years of experience in biopharmaceutical manufacturing. Specializes in downstream process development, technology transfer, process validation and process performance qualification. Implements scale-up strategies from 20L to 200L, optimizes yields, and utilizes chromatography, filtration, microbial fermentation, and protein refolding techniques. Proven expertise in market complaint investigations and implementing quality management systems and computer system validation. Adept at conducting risk assessments and ensuring regulatory compliance in the biotechnology and pharmaceutical manufacturing industry.
Overview
10
10
years of professional experience
2016
2016
years of post-secondary education
Work History
Senior Executive – MSAT
Enzene Biosciences Ltd.
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
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 Compliance
Biocon Biologics India Ltd.
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 Fermentation & Refolding, DS-MSAT)
Reliance Life Sciences
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
03.2015 - 08.2015
- Conducted market research, developed promotional strategies, and provided customer support
Education
PG Diploma - Biotherapeutics
Reliance Institute of Life Sciences
B.Tech - Bioinformatics
Padmashree Dr. D.Y. Patil University
H.S.C - Science
St. Joseph’s Junior College
S.S.C - Science
St. Joseph’s High School
Skills
Process Optimization
Yield Enhancement
Proficient in Downstream Processing Methods
Qualification and Validation Skills
Production Process Oversight
Regulatory Compliance
Experienced in Computer System Validation Processes
Proficient in GMP Standards
Comprehensive Documentation Skills
Risk Identification Skills
Problem Source Analysis
Corrective Action Implementation
Market Complaint Investigations
Process Scaling Expertise
Production Optimization Strategies
MS office
Strategic planning
Regulatory And Audit Exposure
USFDA, EMA, MHRA, WHO, CDSCO, INVIMA, INVIZA, Turkey MOH, Iran MOH, Successfully led manufacturing site inspections and regulatory reviews.
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.
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
Timeline
Senior Executive – MSAT
Enzene Biosciences Ltd.
12.2023 - Current
Business Sales Manager
Diana Advanced Tech Academy
07.2023 - 11.2023
Senior Executive – Manufacturing Compliance
Biocon Biologics India Ltd.
05.2021 - 02.2023
Senior Executive – Manufacturing (Microbial Fermentation & Refolding, DS-MSAT)
Reliance Life Sciences
08.2016 - 10.2020
Marketing Intern
Sanika Pharmaceuticals
03.2015 - 08.2015
B.Tech - Bioinformatics
Padmashree Dr. D.Y. Patil University
H.S.C - Science
St. Joseph’s Junior College
S.S.C - Science
St. Joseph’s High School
PG Diploma - Biotherapeutics
Reliance Institute of Life Sciences