Sandip Chatterjee
sandip.chatterjee@rocketmail.com
8866782712
Deputy Manager
India
Proven ability to build a highly successful
bioassay and review team. An experience of
more than ten years in quality control with a
sound knowledge in cGMP, QMS, method
validation, equipment qualification and well
versed with regulatory guidelines. Implemented
various changes in the procedures to reduce
cost and increase efficiency of the organization.
Rewarded at several points of career for
successfully completing the activities within
strict timelines.
https:/www.linkedin.com/in/sandipchatterjee-a1044112
WORK EXPERIENCE
SKILLS
Deputy Manager
Biocon Biologics
06/2020 - Present,
Incident
India
Achievements/Tasks
Preparation and approval of SOPs, STPs, COAs, Method
validation protocols and reports in Quality Control
department.
CAPA
Change control
Statistical analysis
cGMP
21CFR
Planning of finished product and stability sample testing
of biological products along with the SPR analysis in
Biacore and Binding assay by Flow cytometer
Method Transfer
Handling of QMS (Change control, Incident, CAPA and
Deviation, OOS, OOT) through Trackwise system.
Invitro
Ensuring maintenance of equipment in the department
through qualification (IQ,OQ,PQ,RQ) and validation.
Budget preparation
Reviewing of analytical data in LIMS and providing
statistical inputs in technical queries.
Participation and handling of internal and regulatory
audits.
Involvement in various management projects like COGS
for cost reduction (30%) and efficient manpower
utilization in the lab.
Bioassay
Deviation
SAP
OOT
MS office
PLA3.0
Gen5
SoftMax Pro
Method validation
Equipment Qualification
Cell culture
SOP
OOS
STP
ELSIA
MABs
Audits
Training
Vaccines
Cell bank
Biacore
SPR
Flowcytometer
ORGANIZATIONS
Biocon Biologics (06/2020 - Present)
Deputy Manager
Intas Biopharms (06/2017 - 05/2020)
Yearly budget and CAPEX preparation and approval for
the lab.
Assistant Manager
Participation with contract vendors and external
suppliers as per the lab and customer needs.
Management Staff
Identification of training needs for the lab personnel and
ensuring Data Integrity culture in the bioassay lab.
Executive
Cipla Biotech (08/2016 - 05/2017)
Zydus Biologics (05/2010 - 08/2016)
HONOR AWARDS
Spot Award (12/2019)
Intas Biopharma
Being the efficient employee on the third quarter of 2019
Avengers Award (06/2018)
Intas Biopharma
Working with cross functional teams and completion of projects
within timelines.
Pat on the Back (08/2015)
Zydus Biologics
Excellence towards work for consecutive two quarters.
Exemptia Award (03/2014)
Zydus Biologics
Awarded in appreciation for the work done on Adalimumab
(Exemptia) by Deputy managing director.
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WORK EXPERIENCE
HONOR AWARDS
Assistant Manager
Intas Biopharma
Music competition (08/2009)
06/2017 - 05/2020,
India
MB patel science college
Won 1st prize at college music competition
Achievements/Tasks
Handled bioassays and ELISAs for lot release and stability
analysis of biosimilar & MABs.
LANGUAGES
Manages method transfer and validation, protocol
preparation, execution and report approval.
English
Performed and supervised qualification (URS, DQ, FAT,
IQ,OQ,PQ) of various equipment (Biosafety cabinet, Deep
freezers, CO2 incubators, Dynamic pass box, kill autoclave
and HPHV sterilizer).
Hindi
Handling of Deviation/Incident/ Change control, CAPA,
OOS, OOT.
Handling inventory management and SAP related
activities of the lab.
Bengali
Gujarati
INTERESTS
Preparation and review of MVP, MVR, STP, SOP, DRS,
COA, ATR and specifications.
Quizzing
Eating out
Watching movies
Statistical analysis through software's such as Gen5,
Softmax pro and PLA 3.0.
Handled EMA, Health Canada, ANVISA, WHO & MHRA
audits.
Perform regular verification of laboratory and operation
compliance.
Management Staff
Cipla Biotech
08/2016 - 05/2017,
India
Achievements/Tasks
Technology transfer of the MABs bioassay.
Preparation of IRS and RMP protocols and reports in
bioassays.
Preparation and review of SOP, STP, ATR and
specifications.
Handling of Deviation/Nonconformance/ Change control,
CAPA, OOS, OOT.
Performed and supervised qualification (URS, DQ,
IQ,OQ,PQ) of various equipment (Biosafety cabinet, Deep
freezers, Dynamic pass box).
Calibration of balance along with calibration of
micropipettes.
Review of electronic data.
Training employees for technical and statutory
requirements.
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WORK EXPERIENCE
Executive
Zydus Biologics
05/2010 - 08/2016,
India
Achievements/Tasks
Performing bioassays for lot release and stability testing.
Preparation of IRS protocols and reports.
Preparation and review of SOP, STP, ATR and
specifications.
Online reviewing of data in LIMS.
Handling of Deviation/ Change control, CAPA, OOS, OOT
and malfunction reports.
Performed qualification (URS, DQ, IQ,OQ,PQ) of various
equipment (Biosafety cabinet, Deep freezers, cold rooms
and Dynamic pass box).
Calibration of analytical, micro and precision balance
along with the calibration of micropipettes.
Strong command and knowledge over 21CFR part 11.
CERTIFICATES
Certificate of completion on the topic of corona
virus disease (05/2020)
A course offered by AACC learning lab for laboratory medicine on
NEJM+ knowledge.
EDUCATION
M.Sc
Sardar Patel University
07/2008 - 05/2010,
India
Courses
Microbiology
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