Summary
Overview
Work History
Education
Skills
Recent Job Profile
Languages
Timeline
Generic

BHAVIK NAIK

Ellisville,MO

Summary

Professional with total 11+ years of experience in Pharmaceutical Industry in area of Formulation Development offering outstanding Solid as well as Liquid oral dosage forms development and operation management skills in India and migrated to United States in December 2023.

Overview

11
11
years of professional experience

Work History

Group Leader

Enem Nostrum Remedies Pvt. Ltd.
Andheri East, Mumbai
12.2022 - 09.2023

Scientist-III

Enem Nostrum Remedies Pvt. Ltd.
Andheri East, Mumbai
04.2021 - 11.2022

Scientist-II

Enem Nostrum Remedies Pvt. Ltd.
Andheri East, Mumbai
12.2016 - 03.2021

Research Associate

Micro Labs
Sakinaka, Mumbai
02.2015 - 12.2016

Research Associate

IPCA Laboratories Ltd
Kandivali, Mumbai
09.2012 - 01.2015

Education

M. Pharma -

ROFEL, Shri G. M. Bilakhia College Of Pharmacy, GTU
05.2012

B. Pharma -

ROFEL, Shri G. M. Bilakhia College of Pharmacy
Vapi
05.2010

H.S.C. -

The Ambika High School
Gadat
03.2006

S.S.C. -

The Ambika High School
Gadat
03.2004

Skills

  • New Product Development/ Existing Product Redevelopment
  • From R&D trials to cGMP pilot batch manufacturing with hands on equipment handling across the scales
  • SUPAC guidance & ICH regulations, Quality by Design (QbD), ANDA
  • Excellent written/verbal communication, strategic decision making, Cross-functional team collaboration
  • Handling and Manufacturing of scheduled class (controlled substance) products
  • MS Word, Excel, MS Project, Power Point
  • Performance Monitoring
  • Issue Resolution

Recent Job Profile

  • Leading the team for Development of the intended dosage form with respect to drug chemistry, stability, compatibility to ensure timely completion of product development targets within pre-designated time for US Market.
  • Literature Search.
  • Innovator characterization.
  • To plan and overlook Lab Trials in Formulation Development Department. Communication and coordination with other internal departments as well as commercial site. Literature search. Innovator characterization.
  • Planning and execution of Formula and Process Optimization study.
  • Documentation in all the steps of formulation development including stability study protocol, technology transfer documents, proposal of product specification (In-process and release) and product development report.
  • Preparation of detailed technical reports of the studies completed and periodic reports of ongoing projects.
  • Review and Approval of Analytical reports and protocols.
  • Technology transfer of the developed product to production department.
  • To maintain inventory of the active, inactive and packaging materials used.
  • Development of Solid oral dosage forms (Uncoated, Coated IR/ER/ Bilayer Tablets) and Liquid oral dosage forms (Solution, Suspension) for regulated market.

Languages

English
Full Professional
Gujarati
Native/ Bilingual
Hindi
Full Professional
Marathi
Limited

Timeline

Group Leader

Enem Nostrum Remedies Pvt. Ltd.
12.2022 - 09.2023

Scientist-III

Enem Nostrum Remedies Pvt. Ltd.
04.2021 - 11.2022

Scientist-II

Enem Nostrum Remedies Pvt. Ltd.
12.2016 - 03.2021

Research Associate

Micro Labs
02.2015 - 12.2016

Research Associate

IPCA Laboratories Ltd
09.2012 - 01.2015

M. Pharma -

ROFEL, Shri G. M. Bilakhia College Of Pharmacy, GTU

B. Pharma -

ROFEL, Shri G. M. Bilakhia College of Pharmacy

H.S.C. -

The Ambika High School

S.S.C. -

The Ambika High School
BHAVIK NAIK