Playing Badminton & Travelling
Kalesha Reddy N
Technology Transfer Expert (CIP-AVD)
Hyderabad
Summary
8 Years of experience in Product development from Lab scale to commercial scale implementation in Soft gelatin Capsules. Formulation development of Oral solids, Liquids and Semi-solid dosage forms.
To achieve a challenging and responsible position in the Organization where, I can utilize my technical and interpersonal skills in contributing effectively towards the growth of the organization that offers me professional growth while being resourceful, innovative, and flexible.
Overview
8
8
years of professional experience
2016
2016
years of post-secondary education
6
6
Languages
Work History
Technology Transfer Expert (CIP-AVD)
Dr. Reddy's Laboratories
11.2023 - Current
- Cost improvement process for the commercially approved products for all the non-sterile dosage forms.
- Alternate Vendor Development for the approved drug products (Soft gels, Tablets, Liquids and Semi-Solids).
- Managed time efficiently in order to complete all tasks within deadlines.
- Support for launching batches at External manufacturing site (CMO).
- Adhered to strict safety procedure and safety checks
- Strictly adhered to GDP, cGMP, GLP, Quality and Safety guidelines
Senior Executive Formulation Development
Medreich Limited
11.2022 - 11.2023
- Formulation Design and Development of Solid orals (Tablets) for Regulatory markets like EU & Canadian markets
- Conducting Pre-formulation studies, Process development & process optimization for new drug products
- Troubleshooting activities & Process improvement for existing products for the solid orals
- Patent evaluation, literature search and preparation of formulation strategies
- Reference product characterization/Evaluation
- Preparation of Stability protocols, Compatibility study protocols & reports and etc.
Executive Formulation Development
Strides Pharma Science Ltd
01.2021 - 11.2022
- Formulation Design and Development of Softgelatin Capsules for Regulatory markets like US, EU, TGA & Canadian markets.
- Some ROW markets.
- Development of various drug products for both ANDA & 505(b)(2)
- Conducting Pre-formulation studies, Process development & process optimization for new drug products
- Troubleshooting activities & Process improvement for existing products.
- Development of Veg based soft gelatin capsules & Chewable soft gelatin Capsules.
- Patent evaluation, literature search and preparation of formulation strategies.
- Reference product characterization/Evaluation.
- Preparation of Product Development Protocols, Development BMR’s and BPR’s, Stability protocols, Compatibility study protocols & reports and etc.
- Coordinating with various CFT departments like production / Quality Assurance / Drug Regulatory Affairs for timely Execution of batches.
- Preparation of department SOP’s and their compliance in the department during various operations
- Accurately prepare and maintain records, documents and can perform project work as necessary.
Research Associate (Formulation R&D)
Softgel Healthcare Pvt. Ltd.
02.2017 - 12.2020
- Formulation Design and Development of Softgelatin Capsules for Regulatory markets like US, EU, TGA & Canadian markets & Some ROW markets.
- Development of various drug products for both ANDA.
- Conducting Pre-formulation studies, Process development & process optimization for new drug products.
- Troubleshooting activities & Process improvement for existing products.
- Development of Coating for soft gelatin capsules.
- Patent evaluation, literature search and preparation of formulation strategies
- Reference product characterization/Evaluation
- Execution and Troubleshooting of Ink printing, Laser printing & Coating for Softgelatin capsules
- Preparation of Product Development Protocols, Development BMR’s and BPR’s, Master Formula Records, Stability protocols, Compatibility study protocols & reports and etc.
- Coordinating with various CFT departments like production / Quality Assurance / Drug Regulatory Affairs for timely Execution of batches
- Preparation of department SOP’s and their compliance in the department during various operations
- Knowledge on Equipment/Instrument Qualification activities.
Education
Master of Pharmacy - Pharmaceutics
C.L Baid Metha College of Pharmacy
Chennai, Tamil NaduBachelor of Pharmacy - undefined
M.L. College of Pharmacy
S. Konda, A. P12th/Intermediate - undefined
Sri Chaitanya Junior Kalasala
Ongole, A. P10th/SSC - undefined
Naryana High School
Ongole, A. PSkills
Formulation Development of Oral Solid Dosage form
Trouble shooting & Problem solving
Learning mindset
Friendly, positive attitude
Teamwork and collaboration
Flexible and adaptable
Computer skills
Technical Skills
· Strong understanding on the R&D equipment’s and plant equipment’s.
· Strong skillset in the due diligence of different dosage forms.
· Cross functional collaboration & stake holder management.
· Cost effective formulation development, manufacturing and process.
· Strong understanding on the life cycle management of the product from introduction to launch.
Interests
Personal Information
- Date of Birth: 05/06/93
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
Timeline
Technology Transfer Expert (CIP-AVD)
Dr. Reddy's Laboratories
11.2023 - Current
Senior Executive Formulation Development
Medreich Limited
11.2022 - 11.2023
Executive Formulation Development
Strides Pharma Science Ltd
01.2021 - 11.2022
Research Associate (Formulation R&D)
Softgel Healthcare Pvt. Ltd.
02.2017 - 12.2020
Bachelor of Pharmacy - undefined
M.L. College of Pharmacy
12th/Intermediate - undefined
Sri Chaitanya Junior Kalasala
10th/SSC - undefined
Naryana High School
Master of Pharmacy - Pharmaceutics
C.L Baid Metha College of Pharmacy
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