Summary
Overview
Work History
Education
Skills
Regulatory And Audit Exposure
Professional Attributes
Certifications And Skills
Timeline
RegisteredNurse
Tejal Naik

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

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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

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Tejal NaikExperienced MSAT expert in Drug substance (DS) manufacturing