Rupesh Halarnakar
Team Lead Analytical Chemistry
Badem Bardez - Goa
Summary
Detail-oriented Laboratory Manager highly effective at keeping laboratories running smoothly and efficiently. Knowledgeable about managing supplies, equipment and facilities. Pursuing new professional challenges with the opportunity to make a positive impact on laboratory operations and research success.
Overview
21
21
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Team Lead Analytical Chemistry
Deccan Fine Chemicals Pvt. LTD
Panaji, Goa
08.2018 - Current
- Lead Research and Development activities of Analytical development, Technology transfer of Crop protection products and intermediate in coordination with other project team members and stakeholders
- To support production/QC in commissioning of new products, new technologies, in plant troubleshooting and for continues improvement of existing products in manufacturing.
- Interviewed, hired and trained lab technicians to perform experiments and analyze results.
- Trained staff and provide technical guidance, scheduled work hours and assigned projects for 18-person work group.
- Defined clear targets and objectives and communicated to other team members.
- Kept laboratory in compliance with applicable guidelines and laws.
- Planned and coordinated new development programs to meet deadlines within $[Amount] budget.
- Reviewing analytical data of multiple New Product development (NPD) projects from multiple stakeholders
- Responsible for designing, adapting, validating and applying analytical methods in order to support process development and other related activities for intermediates, AI and formulation
- Provide analytical support to chemist during NPD projects from lab to pilot or commercial scale
- Development and modification of analytical methods for in-process monitoring of the reaction
- Review and approve the results of day to day activity
- Provide analytics support for solving problems during the manufacturing and product life cycle management of products
- Provide technical expertise and support form commissioning of products on commercial scale
- Organize plan and setup laboratory, process, equipment and people for the accreditation of the GLP laboratory
- Plan for the CAPEX, Annual calibration and maintenance of the equipment’s
- Conflict management, appraisal, review and rewards
- Maintain data confidentiality of the multiple customers while interacting with different customers.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
Senior Research Scientist
Syngenta Biosciences Pvt. Ltd,
Panaji Goa
01.2007 - 07.2018
- GLP study director conducting Product chemistry formulation (PCF) short term shelf life studies and Product chemistry Active ingredient studies (PCAI) as per OECD GLP.
- Preparation and review, GLP study Study Plan, Validation Plan, Standard Operating Procedures (SOP), Analytical methods, CoA, Manufacturing specification.
- Supervised junior technicians and scientists.
- Key contributor in GLP laboratory setup and establishment of state of art Global, Analytical GLP test facility commissioning in APAC region, India goa.
- Monitor / perform, review analytical method development and validation as per SANCO guideline, validating computerized system according to OECD and AGIT guidelines.
- Characterization of Analytical Master standard and working standard, Tox batch, Five batch analysis of formulation and AI to support Global Registration and re-registration.
- Recognized as expert in Syngenta, for conducting PCAI, logP, Water solubility and Organic solvent solubility of existing and new AI, its intermediate, data for REACH registration, Brazilian requirement, China 7, SDS, Pesticide manual and Global registration
- Plan, oversight and coordinate with the two global GLP centres (Swiss and USA, sponsors) for the completion of GLP Projects and support in dossier preparation and documentation
- Global product champion for three AIs (pretilachlor, permethrin and cypermethrin), generating AI data for global registration.
- Writing SOP Analytical methods, Manufacturing specification and its implementing in internal and external sites.
- Interacting with auditors during and supporting management in replying audit observations
- Monitor and review the documentation (Study plans, raw data and reports) for GLP compliance, implement appropriate CAPA to avoid re-occurrence of similar issues.
- Responsible to coordinate and ensure the maintenance, troubleshooting, validation / calibration of analytical and subsidiary equipment including its documentation, risk assessment and Data integrity
- Lead capability building and project management with regards to analytical techniques.
- Participated in International collaborative trial for CIPAC analytical methods, Round Robin studies and Inter and Intra laboratory testing method transfer projects.
- Proving analytical support to Global Sourcing team in new vendor evaluation, quality check, conducting round robin test and implementation of analytical method at toller sites in APAC region
- Coordinating with external vendors for AMC of analytical instrument like HPLC and GC.
- Ordering of spares, consumables, chemicals using SAP application.
Quality Control & Assurance Officer
Unichem Laboratories Ltd
Panaji, Goa
01.2003 - 04.2007
- Approved analytical instrumentation Chemist by FDA - Goa, India.
- Performed technical and quality systems audits of laboratory.
- Calibrated and maintained instruments to keep equipment fully operational.
- I handled the development projects of new formulation independently as analytical expert in finished products of tablet, capsules and ointments.
- Interacting with external auditors; USFDA, MCC, TGA, MHRA, WHO, ISO 9000 & 14001 for Quality and Environment Management
- Review of SOP, guidelines and recommending improvement and implementing the new ways of working
- Review/ verification of manufacturing batch records, process validation report, cleaning validation, finished product and raw Material reports as per SOP and ICH guidelines
- Handling of IPQC activity of formulation development and finished product packaging as QA
- Analytical expert in Assay, Dissolution, Five validation batches and related substances.
- Hand on experience in analysis of Raw material using wet chemistry and instrumental techniques.
- Performing Analytical Method validation using HPLC and GC as per ICH guidelines;
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
Quality Control - Trainee
Ranbaxy Laboratories Ltd
01.2002 - 03.2003
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Support production activity in time bound manner and share the analytical results for batch release.
- Conducted analyses of both in-process and finished goods viz., ointment and tablets materials, components and products.
- Testin of finished products; Physical parameters, Assay, Content uniformity, Dissolution and By-products as per USP, BP and IP guidelines.
- Independently handled analytical instruments like HPLC and Karl Fischer.
- Dissolution profiling of validation batches and related substances.
- Support in documentation and audit related activities.
- In-process validation typical five formulation batches.
Education
Master of Science - Physical Chemistry
University of Goa
Panaji Goa - India 07.2000 - 10.2002
Bachelor of Science - Chemistry
University of Goa
Panaji Goa - India 06.1997 - 04.2000
Skills
Chromatography Expert
Reference
Susanne De Benedictis
susanne.de_benedictis@syngenta.com
Head Analytical & Product Chemistry,
Syngenta AG
WMU GLP Testing Facility
Münchwilen –Switzerland
Sven Adolph
sven.adolph@novartis.com
Analytical Expert
Novartis Pharma AG
Basel, Switzerland
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