RAHULKUMAR MANDAL
AHMEDABAD,India
Summary
Accomplished professional with a strong foundation in organizational and planning skills, executive coaching, and visionary leadership. Demonstrates expertise in corporate and internal communication, strategic thinking, and regulatory compliance. Adept at IT systems oversight, risk assessment, and mitigation, with a keen aptitude for decision-making and strategic planning. Recognized for subject matter expertise and the ability to mentor others while maintaining self-awareness. Career goals include leveraging critical thinking skills to drive innovation and enhance corporate strategies.
Overview
9
9
years of professional experience
8
8
years of post-secondary education
1
1
Certification
Work History
SENIOR EXECUTIVE
INTAS PHARMACEUTICAL LTD
Ahmedabad
07.2023 - 03.2025
- Carried out Upstream Mab (HER Inhibitor, Angiogenesis Inhibitor, TNF Inhibitor) manufacturing with zero batch failure in the fiscal year 2024-2025
- Performed the clinical Trails of Two Pipeline products with 89 to 95 % scaleup achievements compared to Satellite batch of Upstream Research and Development with Protein yield of 2.2 mg/ml and 2.4 mg/ml respectively in the scale of 2000L single use system.
- Prepared , Executed URS , QRM, Qualifications documents and commissioned successfully three analytical equipment's.
- Improved operational efficiency by streamlining processes with 6S.
- Implemented cost-saving measures, resulted in significant savings.
- Cultivated high-performance culture, achieved operational excellence.
- Maintaining Manufacturing Records, Deal with Change control Management.
- Responsible for Handling of Shake Flask, Vial thawing, Operation of Single Use Bioreactors and Process Monitoring as per CGMP records
- Providing On job training to new Hires and Trainees.
- Performing Review of SOPs, manufacturing records and dealing with CFTs for Product release.
- Planning, Supervising and Managing team with strong written and Verbal Communication.
- Supervising operations to assess and highlight results.
SENIOR EXECUTIVE
BIOCON BIOLOGICS INDIA LIMITED
BENGALURU
10.2019 - 07.2023
- Responsible for Upstream Operation (Biologics) for two different Mabs manufacturing (US-FDA approved facility).Successfully completed 18 batches and 103 respectively in the year 2022-23.
- Collaborated closely with research team to facilitate clinical trial success.
- Carried out Process Validation of new product with Perfusion technology and ATF Systems with a protein yield of 1.8 mg/ml using a 1000 L Single use system for 68 days.
- Performed three clinical batches trail with Fed batch process in 2000 L scale with average yield of 2.5 mg/ml a successful trail for the Novel molecule.
- Supervise and Manage Shop floor activities with Priorities, adaptability and flexibility to working in different environments.
- Ensured compliance with regulatory standards via diligent documentation and record keeping.
- Identified potential improvements in production processes, fostering efficiency growth.
- Maintained a clean and sterile environment reducing chances of contamination.
- Successfully achieved the Facility clearance for European Medical Agency in the year 2022-23.
EXECUTIVE
INTAS BIOPHARMACEUTICAL LIMITED
Ahmedabad
09.2018 - 09.2019
- Successfully completed Qualification and Validation of Bioreactors, Process vessels, Centrifuge, Homogenizer, spectrophotometer with Vendors in upstream for two different glycoprotein.
- Cooperated with cross-functional teams during project development stages.
- Oversaw installation, testing and commissioning of engineering systems to meet performance and safety requirements.
- Accountable for Shake Flask, Vial thawing activity, Cleaning and sterilization of feed vessels, Bioreactors and Process Monitoring as per manufacturing records for Biologics manufacturing.
- Preparation of SOPs for the equipment ,Proven track record of curiosity with learning agility.
- Self-starter with high initiative and data-driven approach to problem-solving skill.
- Improved workplace safety with stringent enforcement of health and safety regulations.
- Coordinated and supported audit and on-site inspections, which resulted in the EMA approval for one product in 2019.
SENIOR OFFICER
WOCKHARDT LIMITED
Aurangabad
05.2016 - 09.2018
- Responsible Manpower management for media and feed preparation in Cleanroom facility adhering to cGMP.
- Accountable for Cleaning and Sterilization of SS Bioreactors ,Monitoring of process and Performed Scale up for Peptide hormones.
- Performed Quality control test as per Specification and Standard Test Protocols for Peptides using SDS PAGE, Kit based ELISA methods.
- Ensured accuracy of results, verifying laboratory equipment had undergone required servicing and calibration before use.
- Documented test results, deviation reports and trend analyses to guarantee completeness as per cGMP.
- Maintained high standards of personal conduct, contributing to a positive work environment.
- Department member of Fire fighting team to deal with any fire alarms in the cleanroom and to ensure safety.
- Responded promptly and effectively to emergencies using established protocols.
Education
MASTERS OF BIOTECHNOLOGY - Natural sciences, mathematics and statistics
Government Institute Of science
Aurangabad, Maharashtra 05.2014 - 05.2016
BACHELORS OF BIOTECHNOLOGY - Natural sciences, mathematics and statistics
Maulana Azad College of Arts, Science and Commerce
Aurangabad, Maharashtra 05.2011 - 05.2014
CERTIFICATE OF PROFICIENCY IN GERMAN LANGUAGE - Arts
Department of Foreign Language( Dr Babasaheb Marathwada University)
Aurangabad, Maharashtra 05.2012 - 05.2013
NATIONAL CADET CORPS 'B' CERTIFICATE - Military and defence
Ministry of Defence, Government of India
05.2011 - 05.2012
NATIONAL CADET CORPS 'C' CERTIFICATE - Military and defence
Ministry of Defence, Government of India
05.2013 - 05.2014
Skills
- Organizational and planning skills
- Executive coaching and mentoring
- Visionary leadership
- Corporate communication
- Internal communication
- Strategic thinking
- Regulatory compliance
- Self-awareness
- Subject Matter Expertise
- Decision-Making aptitude
- IT systems oversight
- Risk assessment and mitigation
- Good listener and communicator
- Critical thinking
- Decision-making
- Strategic Planning
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Certification
SIX SIGMA WHITE BELT CERTIFICATION, Aveta Business Institute
Custom
(+91) 8793449064, +918793449064
Personal Information
- Date of birth: 09/12/92
- Gender: Male
- Nationality: Indian
Languages
English
Fluent
Hindi
Native
Marathi
Native
Affiliations
- Cooking
- Playing soccer
- Trekking
Timeline
SENIOR EXECUTIVE
INTAS PHARMACEUTICAL LTD
07.2023 - 03.2025
SENIOR EXECUTIVE
BIOCON BIOLOGICS INDIA LIMITED
10.2019 - 07.2023
EXECUTIVE
INTAS BIOPHARMACEUTICAL LIMITED
09.2018 - 09.2019
SENIOR OFFICER
WOCKHARDT LIMITED
05.2016 - 09.2018
MASTERS OF BIOTECHNOLOGY - Natural sciences, mathematics and statistics
Government Institute Of science
05.2014 - 05.2016
NATIONAL CADET CORPS 'C' CERTIFICATE - Military and defence
Ministry of Defence, Government of India
05.2013 - 05.2014
CERTIFICATE OF PROFICIENCY IN GERMAN LANGUAGE - Arts
Department of Foreign Language( Dr Babasaheb Marathwada University)
05.2012 - 05.2013
BACHELORS OF BIOTECHNOLOGY - Natural sciences, mathematics and statistics
Maulana Azad College of Arts, Science and Commerce
05.2011 - 05.2014
NATIONAL CADET CORPS 'B' CERTIFICATE - Military and defence
Ministry of Defence, Government of India
05.2011 - 05.2012
SIX SIGMA WHITE BELT CERTIFICATION, Aveta Business Institute
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