### Analytical Development Senior Scientist Resume

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**Address:**

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#### Professional Summary

Highly skilled Analytical Development Senior Scientist with over 15 years of experience in the
pharmaceutical industry, specializing in the development, validation, and implementation of
analytical methods for Oral Solid Dosage (OSD) forms. Proven leader with a strong track record in
regulatory compliance, project management, and team development. Committed to providing
innovative solutions and driving growth in a dynamic, international work environment.

Highly experienced Analytical Development Senior Scientist with over 15 years of expertise in leading
analytical development teams for Oral Solid Dosage (OSD) forms. Proven track record in the design,
development, validation, and implementation of analytical methods in compliance with regulatory
requirements. Strong leadership and project management skills with a commitment to quality
assurance and rigorous testing. Excellent communicator with a passion for delivering meaningful
solutions and contributing to organizational growth.

#### Key Skills

- Analytical Method Development & Validation

- Regulatory Compliance (USFDA, EMA, ICH)

- HPLC, Dissolution, KF, IR Techniques

- Project Management & Leadership

- Quality Systems & GMP/GLP Practices

- Technical Documentation & Reporting

- Stakeholder Management

- Experimental Design (QbD, DoE)

- Problem-Solving & Troubleshooting

- Excellent Communication Skills

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#### Professional Experience

**DFE Pharma, Hyderabad, India**

*Analytical Development Senior Scientist*

*Month, Year – Present*

- Lead and manage a team of analytical scientists in the development and validation of analytical
methods for OSD forms.

- Ensure compliance with regulatory guidelines (USFDA, EMA, ICH) and quality standards in all
analytical activities.

- Oversee routine laboratory activities, ensuring analytical methods are qualified and fit for purpose.

- Coordinate multiple projects simultaneously, ensuring timely completion and adherence to project
timelines.

- Prepare and review validation protocols, method transfer protocols, and regulatory submission
reports.

- Implement and maintain quality systems and procedures in the analytical development laboratory.

- Manage laboratory resources, including equipment maintenance, calibration, and budgeting.

- Provide mentorship and development opportunities for team members, fostering a collaborative
and productive work environment.

**ABC Pharma, Location**

*Senior Analytical Scientist*

*Month, Year – Month, Year*

- Developed and validated analytical methods for new drug applications (ANDA and NDA).

- Interacted with regulatory authorities to ensure compliance and address technical queries.
- Coordinated method transfer activities, ensuring seamless transitions and resolving technical issues.

- Documented all analytical activities meticulously, preparing detailed reports for regulatory
submissions.

- Managed laboratory resources and ensured adherence to GMP and GLP practices.

**XYZ Laboratories, Location**

*Analytical Scientist*

*Month, Year – Month, Year*

- Conducted analytical testing and validation for various pharmaceutical products.

- Developed and optimized analytical methods using HPLC, dissolution, KF, and IR techniques.

- Prepared validation protocols and reports in compliance with ICH guidelines.

- Assisted in the maintenance and calibration of analytical instruments.

- Supported the implementation of quality systems and procedures in the laboratory.

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#### Education

**Ph.D. in Chemistry/Pharmaceutical Sciences**

*University Name, Location*

*Year of Completion*

**Master’s Degree in Chemistry/Pharmaceutical Sciences**

*University Name, Location*

*Year of Completion*

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#### Certifications
- Certification in Good Manufacturing Practices (GMP)

- Certification in Good Laboratory Practices (GLP)

- Certification in Project Management

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#### Professional Affiliations

- Member, American Chemical Society (ACS)

- Member, International Society for Pharmaceutical Engineering (ISPE)

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#### Publications & Presentations

- Title of Publication, Journal Name, Date

- Title of Presentation, Conference Name, Date

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#### References

Available upon request.

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This resume highlights your extensive experience and skills relevant to the Analytical Development
Senior Scientist position. It is formatted to be ATS-friendly by using standard headings and bullet
points for easy scanning by applicant tracking systems. Let me know if you need any adjustments or
additional information included!
Work Experience
2023 - Present
Deputy Manager
Azurity pharmaceuticals LLC
Key Result Area
1. Formulated detailed working plans for assigned projects to ensure
efficient execution and adherence to project timelines and provides
timeline to Manager.
2. Develops stability indicative analytical methods for drug substance and
finished product.
3. Identify and resolves analytical method problems as required.
4. Responsible for all activities in Analytical Development, including cGLP,
documentation and implementation of departmental quality systems.
5. Responsible for protocol preparation and approval, planning, execution,
review and report preparation of various analytical method validation
parameters.
6. Ensures analytical methods validation is conducted according to
approved validation protocols in a timely manner with accuracy and
precision in compliance of laboratory SOP and guidelines.
7. Responsible for method verifications and publishing of analytical
methods. .
8. Conducts lab investigations for OOS and OOT results.
9. Responsible for technology transfer and Transfer of analytical
procedures activity to support the supervisor.
10. Communicating the requirements for the Leaders and within the team
members for effective cGLP procedures and departmental quality systems
to achieve all outcomes.
11. Assist in departmental housekeeping and other pertinent duties as
assigned in accordance with safety and GLP.
12. Develops and maintain strong relationships within Analytical R&D to
ensure that the projects are delivered on time.
13. Performs all work in accordance with all established regulatory and
compliance and safety requirements.
14. Works in a safe manner collaborating as a team member to achieve all
outcomes.
15. Demonstrate Behaviours that exhibit organizational Values:
Collaboration, Courage, Perseverance, and Passion.
2021 - 2023
Research Associate
Syngene International Limited
Key Result Area
1. Developed and validated assay and RS method by HPLC with
UV/PDA/RI/CAD and FLD detectors using EMPOWER 3 Software for
simple, lyophilized, and complex Injections, and lipid-based Nano
emulsions.
2. Identified and resolved sample preparation challenges using Solid
Phase Extraction (SPE) Techniques, and analyzed the impact of
impurity profiles.
3. Conducted method development for Drug-Partitioning ratio for lipidbased
Nano emulsions.
4. Proficient in method development and validation for Globule size
determination (GSD) and Zeta potential stability indicating parameters
for lipid-based emulsions by Malvern Zeta sizer (Nano ZS).
5. Familiar with USP Type-IV Dissolution Apparatus.
6. Conducted unknown impurity profiling using LC-MS/MS.
7. Developed and validated residual solvents content methods using
GC/HS.
8. Reviewed methods of analysis, protocols, and method development
facilitated discussions with Tech lead.
9. Prepared detailed PPTs on method development, results
compilation, and challenges for weekly client meetings in coordination
with Tech lead.
10. Evaluated internal SOPs versus practice gaps and conducted
assessments.
2018 - 2021
Senior Research Associate-1
Alphamed formulations(Subsidiary of Aspen Pharma care)
Key Result Area
1. Proficient in developing and validating cleaning, assay, dissolution,
and RS methods using HPLC with UV/PDA/RI detectors and EMPOWER
3 Software.
2. Developed methods for residual solvents content using GC/HS.
3. Prepared and reviewed method development and validation reports,
test methods, SOPs, and specifications.
4. Conducted blend assay, BU, CU, dissolution profile, multi-media
dissolution, and dose-dumping studies for various dosage forms.
5. Actively participated in technology transfer procedures to pilot
plants and production, providing troubleshooting and guidance as
necessary.
6. Executed assay, dissolution, and RS method validations in the QC
Plant.
7. Led laboratory investigations and incident inquiries for stability
result deviations, OOT, and OOS in both R&D and QC facilities.
8. Efficiently coordinated with cross-functional teams to ensure
seamless workflow and timely project delivery.
2017 - 2018
Research Scientist
Albany Molecular Research Hyderabad Research Centre Pvt.
Ltd.
Key Result Area
1. Developed and validated methods on HPLC with UV, PDA, and CAD
detectors, demonstrating expertise in method development and
validation.
2. Conducted method development on GC, showcasing proficiency in
analytical techniques.
3. Independently managed projects, including method development,
preparing weekly updates, and participating in technical meetings with
customers.
4. Monitored the GC and HPLC purity analysis, ensuring accurate and
reliable results.
5. Received and analyzed samples submitted by synthesis chemists,
maintaining high standards of accuracy and precision.
6. Maintained documentation, reference and working standards
consumption records, and addressed instrument-related issues,
ensuring smooth operations.
7. Actively participated in work planning and execution, contributing to
efficient project management.
2016 - 2017
Research Chemist
SAI Life Sciences
Key Result Area
1. Developed new methods for product testing, resulting in a 20%
increase in testing efficiency for Assay & RS by HPLC.
2. Analytical support for R&D batches COA release and in-process
sample analysis.
3. Calibrations of HPLC and GC
2015 - 2016
Associate-2
Laurus Labs Pvt Ltd
Key Result Area
- Conducted analysis of raw materials, in process materials,
intermediates, finished products, and Stability Sample analysis.
- Maintained Good Laboratory Practices (GLP) and Good Documentation
Practices (GDP) in the laboratory.

Write ATS friendly resume for me based on below job description and Using My current
resume
Job Discretion:
We are looking for an Analytical Development senior scientist responsible for leading the
analytical development team in the design, development, validation, and implementation of
analytical methods for Oral Solid Dosage (OSD) forms. This role ensures compliance with
regulatory requirements and supports the formulation development process through rigorous
testing and quality assurance.

Do you possess both strong analytical expertise and a strong motivation to provide meaningful
solutions for DFE Pharma's customers and do you like to be a major impactor on our growth
journey? Now it is your chance to join!

Key Responsibilities:

 Lead the department by supervising, coaching, mentoring, developing, and evaluating

professionals within the team.
 Highly knowledgeable in relevant guidelines for method development, optimization and
validation of analytical methods for drug products in accordance with relevant regulatory
requirements (e.g. USFDA, EMA, ICH, etc.) and quality standards.
 Proven track record in analytical method development (ANDA and/or NDA) and
interaction with regulatory authorities/bodies (e.g. USFDA, EMA. ICH etc.).
 Responsible for ensuring routine analytical lab activities are well-coordinated, analytical
methods are qualified and fit for purpose, and information is effectively communicated
and documented promptly.
 Coordinate and manage multiple projects simultaneously, ensuring timely completion
and adherence to project timelines.
 Preparing analytical method validation or verification protocols in accordance with ICH
requirements, conducting validation as per agreed protocols, and preparing the
corresponding reports.
 Preparing analytical method transfer protocols and reports and assisting in resolving
technical queries arising during method transfer activities.
 Ensure accurate and thorough documentation of all analytical activities, including method
development reports, validation protocols, reports for regulatory submissions.
 Implement and maintain quality systems and procedures for the analytical development
laboratory.
 Manage laboratory resources, including equipment, supplies, and budget.
 Ensure the maintenance and calibration of analytical instruments.
Qualifications:

 Ph.D. or Master’s degree in chemistry, Pharmaceutical Sciences, or a related field.

 Possesses 12 to 15 years of experience in analytical development for oral solid dosage
forms in regulatory markets.
 Experience with leading and managing teams is desired.
 Excellent understanding of analytical techniques (HPLC, Dissolution, Water by KF, IR etc.)
and proven troubleshooting record and resolve analytical issues.
 Proven track record of successful method development and validation.
 Strong leadership and project management skills.
 Excellent communication and high proficiency in English (spoken and written).
 Excellent knowledge of GMP practise and GLP practise.

Complimentary skills

Taking ownership for all aspects of a project including preparing protocols and successful
delivery of project milestones.

Some of the skills required to achieve this are listed below:

 Project management track record

 Excellent analytical and problem-solving skills.
 Knowledge of analytical development strategies including principles of quality by design
(QbD) and experimental design strategies (DoE).
 Strong listening and communication skills, with ability to convey complex scientific
concepts through a variety of mediums to both scientific and non-scientific audiences.
 Stakeholder management skills to build strong connections with industry partners, sales
and, the internal organisation.

What we offer

 A dynamic international work environment.

 Working in a new high end laboratory facility in Hyderabad, India
 Continuous learning and development; your development is not only good for your
career; we also benefit from it.
 Short communication and short decision lines.
 An excellent remuneration package.

Team details

 You will be part of an Analytical team.

  Together with, you will form a global leading OSD, Analytical expert panel at DFE
Pharma’s Centre of Excellence.
 You will report to the Director, Centre of Excellence, with a functional reporting line to
Development Manager.
 You will be working at the Hyderabad CoE.

My Current resume:
Madhu Chandra Lekkala
madhulekkala9@gmail.com / (+91) 8886771115 / Hyderabad, Telangan
Summary
Highly motivated and results-oriented Analytical Research scientist 9 with of experience in developing, validating, and
transferring analytical methods for various pharmaceutical dosage forms (oral solids, liquids, injectables) following
regulatory guidelines (e.g., ICH guidelines). Proven expertise in operating and calibrating analytical instrumentation
(HPLC, GC, UV-Vis, IR, etc.) to generate reliable data for quality control activities. Skilled in troubleshooting analytical
issues and ensuring cGMP compliance in laboratory practices and documentation.
Skills
Analytical Method Development & Validation : Development, validation, and transfer of analytical methods for
pharmaceutical dosage forms (HPLC, GC, UV-Vis, IR, etc.) as per regulatory requirements.
Quality Control: Analysis of routine samples (product development batches, stability studies, raw materials) to
ensure product quality.
Good Laboratory Practices (GLP): Performing analyses and maintaining documentation in accordance with GLP
principles.
Good Manufacturing Practices (GMP): Working in a laboratory environment following cGMP regulations.
Analytical Instrumentation: Operation, calibration, and qualification of analytical instruments (HPLC, GC, UVVis,
IR, Dissolution, Disintegration, Viscometer, DSC, Malvern Particle Sizer).
Standard Operating Procedures (SOPs) & Technical Procedures (TPs): Preparation of SOPs, STPs, specifications,
Certificates of Analysis (CoAs), and stability reports.
Data Analysis & Reporting: Data review and release (as assigned).
Regulatory Knowledge: Understanding of regulatory requirements and quality standards for pharmaceutical
products.
Troubleshooting: Identifying and resolving analytical issues and problems.
Technical Writing: Preparing clear and concise technical documents.
Laboratory Safety: Utilizing personal protective equipment (PPE) and adhering to safe laboratory practices.
Experience
Deputy Manager
Azurity pharmaceuticals LLC • Hyderabad, Telangana
12/2023 - Present
Current Responsibilities
Designing, planning, and executing scientific experiments with minimal guidance for projects at different clinical
phases of drug substance and drug product.
Demonstrating proficiency in regulatory guidelines, including GMP and GLP to ensure quality and compliance.
Authoring, reviewing, and approving GMP documents, such as analytical methods, raw data, SOPs, and
qualification reports for analytical instruments.
Reporting and presenting scientific/technical results internally and contributing to publications, presentations,
and patents.
Enforcing quality metrics, compliance, and Good Documentation Practices (ALCOA+) throughout the development
process.
Collaborating effectively with cross-functional teams to ensure project success within timelines.
Mentoring new team members and actively participating in project meetings and networks.
Collaborating with internal and external stakeholders to define the overall analytical control strategy for the
timely manufacture and delivery of drug product.
Research Associate
Syngene International Limited • 06/2021 - 11/2023 Banglore, Karnataka
Developed, validated, and transferred 15 analytical methods for various pharmaceutical dosage forms (oral solids,
liquids, injectables, nasal sprays) to support quality control activities.
Analyzed 10+ of routine samples (product development batches, stability studies, raw materials) to ensure
product quality and compliance with specifications.
Operated and maintained various analytical instruments (HPLC, GC, UV-Vis, IR, etc.) and ensured their
calibration and qualification for accurate data generation.
Qualified10 of working standards following established procedures.
Reviewed and released analytical data (as assigned) to support timely decision-making.
Authored 5 SOPs, STPs, specifications, CoAs, and stability reports for various analytical procedures.
Troubleshooted 4 of analytical issues and identified effective solutions.
Reviewed analytical development and stability data to ensure data integrity and scientific soundness.
Performed analytical activities in support of the Quality Control department.
Senior Research Associate-1
Alphamed formulations(Subsidiary of Aspen Pharma
care) • Hyderabad, Telangana
12/2018 - 06/2021
Developed and validated analytical methods for dissolution, assay & related substances using HPLC and residual
solvents using GC.
Performed calibration and qualification of various analytical instruments (HPLC, GC, UV, etc.).
Conducted dissolution profile, multimedia dissolution, and dose-dumping studies for diverse dosage forms
(tablets, capsules, parenteral).
Performed solubility studies for drug products using HPLC and UV techniques
Validated analytical methods for dissolution, assay & related substances, and residual solvents.
Prepared specifications and standard test procedures for various products.
Conducted method transfer activities across different laboratories.
Research Scientist
Albany Molecular Research Hyderabad Research Centre
Pvt. Ltd. • Hyderabad, TS
04/2017 - 12/2018
key Achievements:
Developed and validated 9 new analytical methods using HPLC and LC-MS for the control and monitoring of
synthetic drug substance manufacturing processes, leading to 20% reduction in analysis time, increased accuracy.
Conducted method development on GC, showcasing proficiency in diverse analytical techniques.
Successfully managed projects independently, including method development, preparing weekly updates, and
participating in technical meetings with customers.
Maintained high standards of accuracy and precision by monitoring GC and HPLC purity analysis and analyzing
samples submitted by synthesis chemists.
Ensured smooth operations by maintaining documentation, reference and working standards consumption
records, and addressing instrument-related issues.
Managed the quality of active ingredients and intermediates with contract manufacturers, including
implementing product specifications, reviewing external partner data, and ensuring adherence to testing
methods.
Managed and coordinated Quality Assurance Records (QAR) for sample testing, supporting changes in processes,
equipment, raw materials, and specifications.
Research Chemist
SAI Life Sciences • Hyderabad, TS
08/2016 - 04/2017
Key Achievements:
Increased product testing efficiency by 20%: Developed new methods for Assay & RS analysis using HPLC,
significantly improving testing speed and throughput.
Provided comprehensive analytical support: Supported R&D batches by performing COA release analysis and inprocess
sample testing, ensuring product quality and timely release.
Maintained instrument accuracy: Conducted regular calibrations of HPLC and GC instruments, guaranteeing
reliable and consistent data.
Associate-2
Laurus Labs Pvt Ltd • Hyderabad, TS
03/2015 - 07/2016
Key Achievements:
Comprehensive Analytical Support: Conducted analysis of raw materials, in-process materials, intermediates,
finished products, and stability samples, ensuring quality control throughout the production process.
Adherence to Regulatory Standards: Maintained strict adherence to Good Laboratory Practices (GLP) and Good
Documentation Practices (GDP) in the laboratory, guaranteeing data integrity and compliance.
Skills
Analytical Method Development & Validation, Analytical Method Transfer, Regulatory Compliance, In-depth
Instrumentation Knowledge, HPLC, Gas Chromatography, MS Office Suite (Word, Excel, PowerPoint), Excellent
communication and collaboration skills., Strong attention to detail and accuracy., Ability to work independently and as
part of a team., Problem-solving and critical thinking skills., Time management and organizational skills.
Education
Post Graduation in Chemistry
Osmania University • Hyderabad, TS
04/2013

nalytical Development Senior Scientist

Syngene International Limited | Bangalore, Karnataka | 06/2021 - 11/2023

 Led analytical method development and validation for a diverse portfolio of

pharmaceutical dosage forms (oral solids, liquids, injectables, nasal sprays), ensuring
compliance with stringent regulatory guidelines (USFDA, EMA, ICH).
 Optimized laboratory operations by managing and maintaining advanced analytical
instrumentation (HPLC, GC, UV-Vis, IR), resulting in accurate and reliable data
generation.
 Enhanced product quality and compliance through rigorous analysis of routine
samples, including product development batches, stability studies, and raw materials.
 Implemented and maintained robust quality systems and procedures in the
analytical development laboratory, ensuring adherence to GMP and GLP standards.
 Successfully transferred 15+ analytical methods to support quality control activities,
facilitating smooth product launch.
 Collaborated effectively with cross-functional teams to ensure timely project
completion and meet critical milestones.

Alphamed Formulations (Subsidiary of Aspen Pharmacare) | Hyderabad, Telangana |

12/2018 - 06/2021

 Developed and validated analytical methods for dissolution, assay, and related
substances using HPLC, and residual solvents using GC, to support product
development and registration.
 Conducted comprehensive dissolution studies (profile, multimedia, dose-dumping)
for various dosage forms (tablets, capsules, parenteral) to characterize product
performance.
 Ensured data integrity and compliance by adhering to GLP and GDP guidelines
throughout the analytical process.

Albany Molecular Research Hyderabad Research Centre Pvt. Ltd. | Hyderabad, TS |

04/2017 - 12/2018

 Accelerated product development by developing and validating 9 new analytical

methods using HPLC and LC-MS, leading to a 20% reduction in analysis time.
 Demonstrated expertise in method development on GC, expanding analytical
capabilities for complex sample matrices.
 Managed and coordinated quality assurance records for sample testing, ensuring
compliance with product specifications and regulatory requirements.

SAI Life Sciences | Hyderabad, TS | 08/2016 - 04/2017

  Enhanced product testing efficiency by developing and implementing new HPLC
methods for assay and related substances analysis.
 Provided critical analytical support for R&D batches through COA release and in-
process sample testing.

Laurus Labs Pvt Ltd | Hyderabad, TS | 03/2015 - 07/2016

 Ensured product quality and compliance through rigorous analysis of raw

materials, in-process materials, intermediates, finished products, and stability
samples.
 Maintained a compliant laboratory environment by adhering to GLP and GDP
guidelines.

Skills

 Analytical Method Development and Validation

 HPLC, GC, Dissolution, Water by KF, IR
 Regulatory Compliance (USFDA, EMA, ICH, GMP, GLP)
 Project Management
 Leadership and Team Management
 Data Analysis and Interpretation
 Problem-Solving and Troubleshooting