Manickavasagam M
IVD Product Development, Manufacturing
New Delhi
Summary
IVD Kits Manufacturing Industrious Factory Manager with expertise in Product Development management, Inventory management, production management, Quality Control, Quality Assurance and business development. Hardworking and punctual leader bringing 21 years of hands-on experience overseeing facility activities and coordinating with sales and business development department to fulfill market demands. Committed FDA Approved Production Chemist and ISO 13485 Internal Auditor with strong production background. Certificate History of completing safe, accurate and physically-challenging work. Repairs and maintain controls and equipment to achieve performance objectives in routine and special gas collection tasks. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
21
21
years of professional experience
5
5
years of post-secondary education
Work History
Factory Manager
Qline Biotech Pvt. Ltd. (Formerly known as "POCT Services PVT. Ltd")
New Delhi
10.2016 - Current
- Kept abreast of current environmental requirements of state and federal environmental protection agencies and mobilized safe and responsible workplace.
- Orchestrated and maintained vibrant continuous improvement and lean manufacturing culture within factory.
- Communicated factory operational needs, objectives and performance standards with senior management and earned 100% upper management support.
- Implemented ISO13485 as per internal, industry and customer quality standards 100%.
- Exchanging market response with company improvement and when needed providing technical support to customers 100% factory productivity and devised plans of action to build productive plant operations.
- Created and delivered manufacturing labor cost and price input for customer quote reviews.
- Managed personnel by implementing company policies, procedures, work rules, and disciplinary action.
- Analyzed production data and prepared reports for senior management.
- Enforced health and safety protocols to promote safe working environment.
- Utilized data analysis tools to identify and resolve production issues.
- Oversaw routine maintenance programs and scheduled service to keep equipment functioning at peak levels.
- Implemented quality control system to review products against technical specifications and corporate standards.
- Evaluated employee performance and provided feedback and training as needed.
- 100% Trained in and implemented emergency response procedures to protect team members and property.
- Coordinated with other departments to align production with customer requirements.
- Collaborated with technical and administrative teams to develop and implement successful corrective plans.
Factory Manager
KEE DIAGNOSTICS PVT. LTD., (Formerly Known As KEE GAD BIOGEN PVT. LTD )
New Delhi
11.2014 - 09.2016
- Kept abreast of current environmental requirements of state and federal environmental protection agencies and mobilized safe and responsible workplace.
- Communicated factory operational needs, objectives and performance standards with senior management and earned 100% upper management support.
- Led productive, motivated and loyal manufacturing team and generated factory-wide customer focus and pride in workmanship.
- Delivered factory-level communications and tactical direction and drove achievement of quality, delivery, productivity and financial performance goals and objectives.
- Created and delivered manufacturing labor cost and price input for customer quote reviews.
- Analyzed production data and prepared reports for senior management.
- Oversaw routine maintenance programs and scheduled service to keep equipment functioning at peak levels.
- Collaborated with technical and administrative teams to develop and implement successful corrective plans with achievement of 100%
- Trained in and implemented emergency response procedures to protect team members and property.
- Updated logs and submitted timely reports detailing activities in line with regulatory standards.
- Devised and administered cost control initiatives saving 30%.
Factory Manager
ADI DIAGNOSTICS PVT. LTD
Hydrabad
03.2014 - 09.2014
- Kept abreast of current environmental requirements of state and federal environmental protection agencies and mobilized safe and responsible workplace.
- Orchestrated and maintained vibrant continuous improvement and lean manufacturing culture within factory.
- Communicated factory operational needs, objectives and performance standards with senior management and earned full upper management support.
- Spearheaded product and process quality initiatives with full compliance to internal, industry and customer quality standards.
Factory Manager
MEDICLONE BIOTECH PVT. LTD
Chennai
04.2012 - 11.2013
- Kept abreast of current environmental requirements of state and federal environmental protection agencies and mobilized safe and responsible workplace.
- Orchestrated and maintained vibrant continuous improvement and lean manufacturing culture within factory.
- Communicated factory operational needs, objectives and performance standards with senior management and earned full upper management support.
- Spearheaded product and process quality initiatives with full compliance to internal, industry and customer quality standards to 100%.
Production Manager
MEDICLONE BIOTECH PVT. LTD
Chennai
11.2010 - 04.2012
- Sourced materials to keep up with production goals and meet customer demands.
- Resolved issues quickly to maintain productivity goals.
- Managed continuous improvement initiatives to drive gains in quality, flow, and output achieved 100%.
- Created streamlined production schedules and collaborated with production employees to communicate objectives and goals.
- Standardized production procedures, job roles, and quality assurance guidelines.
- Reviewed work for quality and compliance with company standards and design specifications.
- Reviewed maintenance and repair problems to determine appropriate action for resolution.
- Managed internal operational standards and productivity targets.
Product Development Manager
MEDICLONE BIOTECH PVT. LTD
Chennai
10.2009 - 11.2010
- Reviewed product development budgets, expenditures and research.
- Distinguished product issues and gathered information on customer experiences.
- Created product roadmaps to help guide product development processes and align with overall business goals and achieved 90% productivity.
- Liaised with internal and external parties on procurement of new product formulations, international requirements and regulatory changes.
- Approved product documentation to promote easy-to-follow manuals and technical documents.
- Identified opportunities for new products and improvements to existing products to increase sales.
- Maintained internal product knowledge database.
- Directed concept design, feature definitions and production support.
- Created and executed strategies to drive development and success of products.
- Continually maintained and improved company's reputation and positive image in markets served.
- Developed creative presentations, trend reports, kitted assets, and product data sheets.
- Launched successful digital marketing campaigns that achieved goals for increased website traffic.
Customer Support Manager
ACCUREX BIOMEDICAL PVT.LTD (
Mumbai
01.2008 - 10.2010
- Employed comprehensive benchmarks to establish and monitor customer service standards. with achievements of 100%
- Identified call trends to improve efficiency, reduce problem calls and suggest solutions to upper management.
- Generated status and performance reports to facilitate continuous improvement to reduce 0% product complaints.
- Collaborated with cross-functional departments to formulate product and process improvements based on customer feedback.
- Collaborated with cross-functional departments to update teams on current products, services and troubleshooting techniques.
- Completed performance evaluations and rectified issues to service clients and more effectively meet KPIs.
- Utilized crisis management techniques to offer corrective solutions and maximize customer satisfaction.
- Managed customer service effectiveness by monitoring performance and assessing metrics.
- Audited customer support procedures and collaborated regionally to promote standardization across offices.
- Monitored employee performance to identify areas for improvement and additional training needs.
- Discovered and resolved complex customer issues to reduce negative impact to business outcomes.
- Implemented process improvements to automate document management systems, call logs and invoicing data to enhance department efficiency.
Senior R&D Chemist
ACCUREX BIOMEDICAL PVT.LTD (
Mubai
04.2006 - 01.2008
- Illustrated potential obstacles when conducting site assessments for planned projects and achieved >50%
- Participated in formal internal design reviews of proposed products and components.
- Developed work plans for various personnel roles based on strengths and talents.
- Coordinated sampling and analysis tasks to verify quality of finished products.
- Conducted feasibility studies for proposed projects using potential ROI and risk management.
- Developed comprehensive engineering documents for all projects.
- Developed and maintained relationships with suppliers to facilitate quality and timely delivery of materials.
- Implemented automated systems to improve accuracy and efficiency of engineering processes.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Analyzed and interpreted customer requirements to develop engineering solutions.
Diagnostic Specialist
ACCUREX BIOMEDICAL PVT.LTD (
Chennai
05.2004 - 03.2006
- Researched sales opportunities and possible leads to exceed sales goals and increase profits and achieved 1005% continuously.
- Analyzed past sales data and team performance to develop realistic sales goals.
- Achieved sales goals and service targets by cultivating and securing new customer relationships to 100%.
- Increased revenue by implementing effective sales strategies in sales cycle process from prospecting leads through close.
- Created and implemented successful sales campaigns to drive leads and increase sales.
- Directed sales support staff in administrative tasks to help sales reps close deals.
- Fielded customer complaints and facilitated negotiations, resolving issues and reaching mutual conclusions.
- Contributed to event marketing, sales and brand promotion.
- Built diverse and consistent sales portfolio.
- Recorded accurate and efficient records in customer database.
- Attended monthly sales meetings and quarterly sales trainings.
- Consulted with businesses to supply accurate product and service information.
- Selected correct products based on customer needs, product specifications and applicable regulations.
Biochemist
SARATH LAB
Chennai
11.2002 - 04.2004
- Used hospital and lab information systems to label and track specimens and supplies.
- Processed and prepared samples for testing.
- Recorded final disposition into sample inventory system and storage program.
- Completed record logs and other administrative work in support of biochemistry lab operations.
- Set up and calibrated laboratory instruments and equipment to prepare for testing purposes.
- Filtered and screened antibodies for development of various assays.
- Studied mutations in organisms leading to cancer or other diseases.
- Developed strong communication and organizational skills through working on group projects.
- Identified issues, analyzed information and provided solutions to problems.
Education
Master of Science - Biochemistry
Bharathidasan University
Tiruchirappalli 11.2000 - 04.2002
Bachelor of Science - Biochemistry
Bharathidasan University
Tiruchirapalli 07.1995 - 11.1998
Skills
New Product Development of Clinical Chemistry kits like ADA, Enzymatic Creatinine, Direct HDL, Direct LDL, Lipase, HbA1C, Ck, CK-MB, Ammonia, Iron TIBC, G6PDH, etx
undefinedTimeline
Factory Manager
Qline Biotech Pvt. Ltd. (Formerly known as "POCT Services PVT. Ltd")
10.2016 - Current
Factory Manager
KEE DIAGNOSTICS PVT. LTD., (Formerly Known As KEE GAD BIOGEN PVT. LTD )
11.2014 - 09.2016
Factory Manager
ADI DIAGNOSTICS PVT. LTD
03.2014 - 09.2014
Factory Manager
MEDICLONE BIOTECH PVT. LTD
04.2012 - 11.2013
Production Manager
MEDICLONE BIOTECH PVT. LTD
11.2010 - 04.2012
Product Development Manager
MEDICLONE BIOTECH PVT. LTD
10.2009 - 11.2010
Customer Support Manager
ACCUREX BIOMEDICAL PVT.LTD (
01.2008 - 10.2010
Senior R&D Chemist
ACCUREX BIOMEDICAL PVT.LTD (
04.2006 - 01.2008
Diagnostic Specialist
ACCUREX BIOMEDICAL PVT.LTD (
05.2004 - 03.2006
Biochemist
SARATH LAB
11.2002 - 04.2004
Master of Science - Biochemistry
Bharathidasan University
11.2000 - 04.2002
Bachelor of Science - Biochemistry
Bharathidasan University
07.1995 - 11.1998
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