Summary
Overview
Work History
Education
Skills
Certification
Regulatory Quality Assurance
Reporting Details
Family Background
Personal Belief
Personal Information
Awards
Leadership Management Skills
Timeline
Generic
Dattatray Mahanor

Dattatray Mahanor

ADL Manager
Thane

Summary

Highly skilled and results-driven Analytical Team Lead with extensive experience in analytical method development, validation, and quality assurance for API, Intermediate, and specialty chemical testing. Proven expertise in managing and guiding a team of professionals, including officers and executives, ensuring compliance with cGMP standards, and optimizing laboratory operations. Adept at coordinating complex analytical activities, managing instrument calibration, and ensuring the accuracy of raw material and finished product testing.

Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.

Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

17
17
years of professional experience
8021
8021
years of post-secondary education
2
2
Certifications
3
3
Languages

Work History

Manager (ADL Department)

Soujanya Life Sciences
Navi-mumbai
08.2024 - Current
  • Spearheaded the analytical department, overseeing data-driven strategy, process optimization, and cross-functional collaboration to enhance decision-making, operational efficiency, and business growth.
  • Overseeing Analytical Method Development, Method Validation, stability studies, force degradation studies, and method transfer activities for APIs, intermediates, Raw materials, and reaction monitoring using HPLC, GC, MS, PSD, dissolution, and chemical methods. (RS, Assay, Residual solvents, Genotoxic impurities, Nitrosamines, Content method, etc.)
  • Managing daily analytical activities, ensuring compliance with cGMP, safety, and quality standards.
  • Good understanding of the pharmaceutical development process.
  • Good knowledge of Quality by Design (QbD) principles and optimization techniques.
  • Planning and executing raw material and finished product analysis, method validation, and method transfer.
  • Handling instrument calibration, stability analysis, WRS preparation, and reference standards procurement.
  • Reviewing and releasing finished products, intermediates, raw materials, and reaction monitoring results.
  • Managing analytical instruments, including maintenance, calibration, and AMC/CMC coordination.
  • Training recruits on analytical instruments and investigating deviations and incidents.
  • Overseeing procurement activities, chemical inventory, and CAPEX for analytical operations.
  • Managed and motivated employees to be productive and engaged in work.
  • Accomplished multiple tasks within established timeframes.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Controlled costs to keep business operating within budget and increase profits.
  • Improved marketing to attract new customers and promote business.
  • Cross-trained existing employees to maximize team agility and performance.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Developed and maintained relationships with customers and suppliers through account development.
  • Managed budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.
  • Achieved departmental goals by developing and executing strategic plans and performance metrics.
  • Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
  • Established performance goals for employees and provided feedback on methods for reaching those milestones.
  • Reduced waste and pursued revenue development strategies to keep department aligned with sales and profit targets.
  • Launched quality assurance practices for each phase of development
  • Streamlined and monitored quality programs to alleviate overdue compliance activities.
  • Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
  • Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
  • Managed senior-level personnel working in marketing and sales capacities.
  • Controlled resources and assets for department activities to comply with industry standards and government regulations.
  • Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
  • Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
  • Improved staffing during busy periods by creating employee schedules and monitoring call-outs.

Research Scientist (Sr.Manager)

Aarti Research and Technology Center
Navi-mumbai
03.2020 - 08.2024
  • Leading Analytical Team-3 (12 members, including two Assistant Managers and ten Executives).
  • Overseeing Analytical Method Development for APIs, intermediates, impurities, and reaction monitoring using HPLC/GC/Chemical method.
  • Managing daily analytical activities, ensuring compliance with cGMP, safety, and quality standards.
  • Planning and executing raw material and finished product analysis, method validation, and method transfer.
  • Handling instrument calibration, stability analysis, WRS preparation, and reference standards procurement.
  • Reviewing and releasing finished products, intermediates, raw materials, and reaction monitoring results.
  • Managing analytical instruments, including maintenance, calibration, and AMC/CMC coordination.
  • Overseeing procurement activities, chemical inventory, and CAPEX for analytical operations.
  • Evaluated new technologies for potential integration into existing research processes, driving continuous improvement efforts.
  • Designed experiments using sophisticated statistical techniques, yielding robust results that supported key hypotheses.
  • Identified opportunities for innovation by staying abreast of emerging trends in the scientific community.

Research Scientist

MacLeod's Pharmaceuticals
Vapi
09.2017 - 03.2020
  • Led Analytical Method Development, Validation, Verification, and Transfer activities.
  • Planned daily ADL operations to support CRD Lab.
  • Prepared AMS, STP, SOPs, guidelines, and literature surveys for API.
  • Provided on-the-job training for new employees.
  • Ensured GMP compliance and reviewed routine data, audit trails, and tech transfer reports.
  • Evaluated new technologies for potential integration into existing research processes, driving continuous improvement efforts.
  • Mentored junior scientists, fostering professional growth and enhancing team capabilities.
  • Streamlined research processes to meet tight deadlines for multiple projects.
  • Developed novel research methodologies for improved data analysis and interpretation.
  • Identified opportunities for innovation by staying abreast of emerging trends in the scientific community.
  • Generated data models and performed analysis to produce reports outlining results.
  • Presented research findings at international conferences, increasing visibility and recognition within the field.
  • Managed laboratory budgets effectively, allocating funds strategically for maximum impact on research outcomes.
  • Maintained a safe working environment by enforcing strict adherence to laboratory safety guidelines.
  • Completed testing projects by deadline and under budget for company-wide initiatives.
  • Led multidisciplinary teams in solving complex problems, leveraging diverse expertise to achieve innovative solutions.
  • Established partnerships with industry leaders to secure resources and support for cutting-edge research initiatives.
  • Enhanced research efficiency by optimizing experimental designs and protocols.
  • Streamlined laboratory workflows, resulting in reduced costs and increased productivity.
  • Maintained confidentiality of all patient information to conform to HIPAA, internal, and other regulatory standards.
  • Secured intellectual property protection for groundbreaking inventions through diligent patent application processes.
  • Performed research into study topics to increase knowledge and to provide valuable contributions.
  • Documented and reported test results after making graphical solutions and representations.
  • Spearheaded cross-functional projects, ensuring timely completion while maintaining high-quality standards.
  • Utilized expertise in microbiology, chemistry, and hematology to help with diagnosis of medical issues.

Senior Research Associate

Lupin Research Park
Pune
09.2010 - 06.2017
  • Developed and validated analytical methods for APIs and intermediates.
  • Conducted method verification, equivalency, and transfer processes.
  • Managed ADL planning and supported CRD Lab operations.
  • Prepared protocols, investigation reports, and regulatory documentation.
  • Delivered training sessions for new employees.
  • Maintained GMP compliance and reviewed audit trails, routine data, and tech transfer activities.
  • Performed instrument calibration and maintenance.

Research Associate

Calyx Pharmaceuticals Ltd.
Dombivli (E)
10.2008 - 09.2010
  • Conducted routine analysis, method development, and stability studies for bulk drug actives.
  • Calibrated analytical instruments (HPLC, UV-Vis Spectrophotometer, KF, SOR).
  • Provided analytical support for reaction monitoring and synthesis teams.
  • Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
  • Assisted in the development of new research proposals, resulting in increased funding opportunities and project growth potential.
  • Monitored progress against project timelines, ensuring timely completion of deliverables while maintaining high-quality standards.
  • Prepared samples for analysis by performing complex sample preparation tasks.
  • Monitored and documented safety standards to verify compliance.
  • Kept abreast of current industry, scientific and regulatory developments and issues.
  • Interpreted laboratory results to provide technical advice to scientists.
  • Prepared reagents and solutions following standard laboratory formulas and procedures.
  • Cooperated with other technicians to develop and test new protocols.
  • Coordinated and managed laboratory projects and experiments.
  • Collaborated with multidisciplinary teams to drive project success and achieve objectives.

Education

M.Sc. - Organic Chemistry

NAC&S College
Ahmednagar, Pune
07.2008

B.Sc. - Chemistry

NAC&S College
Ahmednagar, Pune
06.2006

H.S.C. -

Dnyaneshwar College
Newasa, Pune

S.S.C. -

Ghadge High School
Newasa, Pune

Skills

  • Analytical Method Development

  • Analytical Instrumentation

  • Analytical Method Validation

  • Vendor Verification

  • IQ, OQ, PQ Activities

  • Calibration Activities

  • Stability Analysis

  • WRS Preparation

  • Characterization activities

  • Preparation and Standardization of Reagents

  • Review and Release of Analytical Data

  • Chemical Inventory Management

  • Control Sample Evaluation

  • Team Leadership

  • Coordination and Supervision

  • Planning and Execution

  • Incident Investigation

  • Deviation Management

  • Compliance with EHS

  • Procurement of Reference Standards

  • QMS

  • DMS

  • Compliance with cGMP

  • Compliance with NABL

  • Compliance with FDA

  • Preparation of SOPs

  • Review of Specifications

  • Coordination of Analytical Method Validation Reports

  • Experience with IQ, OQ, and PQ Documentation

  • Strong Analytical and Problem-Solving Abilities

  • Cross-functional Collaboration

  • Attention to Detail

  • Project Management

  • Problem-Solving & Critical Thinking

  • Computer Proficiency

  • Teamwork & Collaboration

  • Numerical & Analytical Skills

  • Communication & Presentation

Certification

CCIT (Computer course in information technology)

Regulatory Quality Assurance

  • QMS, DMS, Compliance with cGMP (Current Good Manufacturing Practice) Standards.
  • Compliance with NABL (National Accreditation Board for Testing and Calibration Laboratories) and FDA (Food and Drug Administration) Standards.
  • Preparation, Review, and Revision of SOPs (Standard Operating Procedures).
  • Review and Approval of Specifications and Test Procedures.
  • Coordination of Analytical Method Validation Reports.
  • Experience with IQ, OQ, and PQ Documentation of Instruments.

Reporting Details

GM, 2 months, As per company Standards

Family Background

  • Khandu Mahanor, Father, Farmer, 59
  • Manda Mahanor, Mother, Housewife, 55
  • Hema Mahanor, Wife, Housewife, 38
  • Saiviraj Mahanor, Son, 15
  • Aaradhya Mahanor, Daughter, 9

Personal Belief

Success is the result of 5 Qualities- Interest, Confidence, Hard work, Dedication, and Planning.

Personal Information

  • Nationality: Indian
  • Marital Status: Married

Awards

  • Bravo Awards (Lupin Research Park)
  • Best Initiative of the quarter (ARTC)
  • Sustainability champion of the quarter (ARTC)

Leadership Management Skills

  • Team Leadership and Staff Management
  • Coordination and Supervision of Analytical Lab Operations
  • Planning and Execution of Daily Analytical Activities
  • Incident Investigation and Deviation Management
  • Compliance with EHS Statutory Requirements and Promotional Activities
  • Procurement of Reference Standards and Lab Equipment

Timeline

Manager (ADL Department)

Soujanya Life Sciences
08.2024 - Current

Research Scientist (Sr.Manager)

Aarti Research and Technology Center
03.2020 - 08.2024

Research Scientist

MacLeod's Pharmaceuticals
09.2017 - 03.2020

Senior Research Associate

Lupin Research Park
09.2010 - 06.2017

Research Associate

Calyx Pharmaceuticals Ltd.
10.2008 - 09.2010

M.Sc. - Organic Chemistry

NAC&S College

B.Sc. - Chemistry

NAC&S College

H.S.C. -

Dnyaneshwar College

S.S.C. -

Ghadge High School

Similar Profiles

CREATE PROFILE
Dattatray MahanorADL Manager