SINOJ K.J
Sterile Injectable ( Fill & Finish And Technology Transfer)
Kasaragod
Summary
Dynamic and results-driven professional with over 18 years of experience in sterile injectable manufacturing, specializing in drug product (DP) manufacturing/ fill finish and technology transfer processes. Expertise in leveraging a diverse skill set to drive organizational success while fostering an environment that promotes growth and innovation. A strong commitment to strategic thinking and collaboration ensures alignment with industry goals and enhances operational efficiency. Passionate about continuous personal and professional development, prepared to make impactful contributions in a challenging role within a well-managed industry.
Overview
19
19
years of professional experience
Work History
Technology Transfer and Pilot Plant department
CIPLA Ltd
07.2016 - Current
- Collaborate with various departments, including Production, Quality Assurance, Quality Control, Regulatory Affairs, Project Management, and Research & Development to ensure the seamless transfer of injectable products from development to commercial manufacturing site (Own units and CMO).
- Responsible for executing feasibility, registration and commercial validation batches for injectable products in the manufacturing sites in collaboration with cross-functional teams.
- Responsible to complete the technology transfer documents from R&D to manufacturing sites.
- Review of Change control, Master formula record, Batch manufacturing records, Process validation protocols, process validation reports, QbD documents, CAPA, FMECA and investigation reports related to new products and validation batches.
- Provide technical guidance to the manufacturing team, troubleshoot process issues, and ensure compliance with GMP and regulatory standards. Offer support to manufacturing units during regulatory audits.
- Conduct meetings or teleconferences with the manufacturing unit team and R&D department to evaluate the feasibility of new projects, ensure equipment readiness, and track raw materials.
- Prepare and review gap analysis for registration and validation batches, coordinating with the regulatory department to finalize gap analysis documents and manage variation filings.
- Leading the Injectable pilot plant which includes man, material and equipment management.
- Plan and execution of experimental batches in pilot plant in coordination with R&D team.
- Responsible for review of all documents [Sops, Protocols, QMS, BMR etc.] for pilot plant.
- Responsible for carrying out periodic qualification of pilot plant equipment and utilities as per schedule.
- Formulation Technology Transfer & Injectable pilot plant: [Aseptic manufacturing] -From Jun 2017 to present
Aseptic manufacturing Lead
CIPLA Biotec
07.2016 - 06.2017
- Responsible for leading, planning and monitoring of day-to-day activities of production (Aseptic manufacturing) and ensuring delivery of products on time.
- Preparation and execution of Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) protocols and reports for the Production equipment.
- Responsible for the review and execution of Master Batch Records, Batch Manufacturing Records, Protocols, Standard Operating Procedures, process validation protocol, Media fill protocol and report.
- Enhance process excellence by conducting regular reviews, updating standard operating procedures, and implementing best practices to boost yield efficiency and throughput.
- Responsible for handling change control, deviations, CAPA and investigations.
- Responsible for facilitate review and implementation of SOPs.
- Responsible to ensure all the production activities are carried incompliance with cGMP and EHS norms and any time readiness for regulatory audit.
- Responsible to coordinate with cross functional team for the smooth flow production activities.
- Responsible for preparation of production plan and ensuring the required material, documents, equipment are available.
- Responsible for conducting training to newcomers.
- Production Department from July 2016 to Jun 2017 [Aseptic manufacturing Lead at CIPLA Biotec GOA]
Assistant Manager -Production
HETERO LABS
09.2014 - 07.2016
- Overseeing manufacturing, filtration, aseptic filling, and lyophilization operations to ensure all activities comply with cGMP and EHS standards.
- Responsible for preparing and reviewing key documents, including batch records, protocols, and standard operating procedures.
- Handling of change control, Deviation, Incidents and carrying out investigation.
- Responsible for review of executed batch records, process validation protocol and report, logbooks, hold time protocol and reports for timely closure of documents.
- Updating daily and monthly production report.
- Co coordinating with QA, QC, Warehouse, Engineering for achieving the day to day production targets.
- Worked for HETERO LABS as Assistant Manager -Production from Sept 2014 to July 2016. [Oncology Division, Fill & Finish]
Sr. Executive
Mylan
01.2013 - 08.2014
- Supervising the Manufacturing, Filtration, Vial washing, Depyrogenation, Sterile Filling, Lyophilization, sealing and visual inspection activities as per batch records and timely reporting to superior.
- Troubleshoots basic machine issues and contacts maintenance support when necessary to ensure the production timeline is met.
- Co coordinating with QA, QC, Warehouse, Engineering for achieving the day to day production targets.
- Online updation of Batch records and logbooks.
- Review of executed BMRs.
- Ensuring the equipments /instruments in the production area are calibrated / Validated as per frequency.
- Worked for Mylan as a Sr. Executive from Jan 2013 to Aug 2014. [Oncology Division, Fill & Finish]
Production Executive
KEMWELL BIOPHARMA
06.2011 - 01.2013
- Assisted for new injectable plant set up with capacity of liquid in vials, lyophilized vials and prefilled syringes.
- Co ordinated with vendors for the execution of project works related to Sterile injectable (fill finish) area.
- Review of DQ and giving the technical inputs.
- Review of Area /equipment layouts pertaining to Sterile injectable fill finish area.
- Preparation of URS, Installation Qualification, Operational Qualification, Performance Qualification protocol etc for fill finish area.
- Preparation of Standard Operating procedures.
- Co ordinating for the commissioning of equipment in the production area.
- Execution of Installation Qualification ,Operational Qualification, Performance Qualification for Vial washing machine, Depyrogenation Tunnel, Filling Machine, Sealing Machine, CIP/SIP Station,Cold Room, Deep Freezer,pH meter, Weighing Balance, LAF etc.
- Training of colleagues in carrying out activities.
- KEMWELL BIOPHARMA as a Production Executive( Fill & Finish). From Jun 2011 to Jan 2013
Jr. Execution Production
BIOCON Ltd.
08.2006 - 05.2011
- Involved in preparing document for plant start up operations.
- Involved in assisting in technology transfer for insulin and other products with R&D team.
- Compounding of products as per batch records.
- Sterile Filtration of prepared drug solutions.
- Operation of CIP/SIP Skid, Manufacturing vessels.
- Operation and troubleshooting of autoclave.
- Operation sealing machine.
- Operation vial washing machine.
- Involved in line qualifications by performing Ascetic process simulations.
- Carried out equipment installation , operational and performance qualifications.
- Maintained plant and documents as per the cGMP norms.
- Co-ordinating with other departments with respect to day to day activities and trouble shooting.
- Involved in gowning qualification activities.
- Involved in LAF qualification activities.
- Planning of day-to-day work of the group and timely completion of activities.
- Controlling and maintaining process parameters as per Batch Manufacturing Record.
- Performing the integrity testing for all filters.
- Training of colleagues in carrying out activities.
- Operation of Vial Washing machine.
- BIOCON Ltd. From Aug - 2006 to May -2011 ( Fill & Finish).
Education
M.Tech - Pharmaceutical operations & management
BITS PILANI
M.Sc - Chemistry
Kuvempu university
KarnatakaB.Sc - Chemistry
Mary Matha College Alakode
KeralaPLUS TWO - undefined
Govt.Higher Higher Secondary School Kamballur
KeralaS.S.LC - undefined
St.Thomas Higher Higher Secondary School Thomapuram
KeralaSkills
Sterile manufacturing- hands on experience in Compounding, aseptic filtration,aseptic filling and lyophilization
Formulation Technology transfer - Sterile injectable
Technology transfer and scale up of products from R&D to manufacturing sites
Gap analysis, QbD and technology transfer documents
Handling of change control, Deviation, CAPA and investigation
Preparation of protocols,batch records and standard operating procedures
Green field project- sterile injectable
IQ, OQ and PQ of equipment
Exposure to RABS and Isolator technology
Review of process validation protocol and report
Handling of pilot plant operation
Accomplishments
- Part of successful USFDA audit - 3 times.
- Part of successful MHRA audit.
- Demonstrated the formulation and filtration process during USFDA audit.
Timeline
Technology Transfer and Pilot Plant department
CIPLA Ltd
07.2016 - Current
Aseptic manufacturing Lead
CIPLA Biotec
07.2016 - 06.2017
Assistant Manager -Production
HETERO LABS
09.2014 - 07.2016
Sr. Executive
Mylan
01.2013 - 08.2014
Production Executive
KEMWELL BIOPHARMA
06.2011 - 01.2013
Jr. Execution Production
BIOCON Ltd.
08.2006 - 05.2011
M.Tech - Pharmaceutical operations & management
BITS PILANI
M.Sc - Chemistry
Kuvempu university
B.Sc - Chemistry
Mary Matha College Alakode
PLUS TWO - undefined
Govt.Higher Higher Secondary School Kamballur
S.S.LC - undefined
St.Thomas Higher Higher Secondary School Thomapuram