Scientist Differentiated Formulation Development

7+ years

Not Disclosed

Hyderabad

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: M.Sc./PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Name: Dr. Reddy’s Laboratories Ltd.
Location: India (Integrated Product Development Organisation)
Date: Immediate

Company Overview

Dr. Reddy’s Laboratories Ltd. is a global leader in the pharmaceutical industry, dedicated to accelerating access to affordable and innovative medicines. Since 1984, the company has expanded its reach to over 66 countries, employing more than 24,000 people. Dr. Reddy’s core values emphasize access, affordability, innovation, and sustainability, aiming to reach over 1.5 billion patients globally by 2030. The company fosters an inclusive work environment and values diversity in its workforce.

Job Title: Scientist - Differentiated Formulation Development

Department: Integrated Product Development Organisation
Location: India

Job Summary

Dr. Reddy’s is seeking a Scientist to join the Differentiated Formulation Development team. This role involves the development of differentiated product formulations, ensuring successful completion of bio studies, scaling up, and responding to deficiencies with proper justification for global markets. You will lead the development of robust, stable formulations from bench scale to commercial level, ensuring that products meet regulatory standards and are suitable for bioequivalence studies.

Key Responsibilities

Formulation Development:
- Review and analyze data, collaborate with the Strategy design team, and prioritize product criticality.
- Coordinate with preformulation teams to strategize reverse engineering studies and ensure comprehensive characterization.
- Oversee product development, ensure timely milestone achievements, and conduct formulation experiments.
- Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to filing preparation.
Documentation and Compliance:
- Write batch plans, protocols, and sampling plans.
- Perform and review experiments, maintaining proper documentation (ELN).
- Prepare comprehensive responses to regulatory queries related to formulation development.
Regulatory and Safety:
- Ensure robust regulatory strategies for drug products, including compliance with FDA, cGMP, and cGLP standards.
- Develop Standard Operating Procedures (SOPs) for formulation processes and ensure adherence to safety standards.
Team Development:
- Provide guidance to develop formulation capabilities within the team and foster an environment of learning and growth.

Qualifications

Education: Masters/Ph.D. in Pharmaceutics.
Experience: M. Pharm with 7+ years or Ph.D. with 2+ years of experience in Differentiated Formulation Development.

Skills & Attributes

Technical Skills:

Extensive experience in end-to-end product development for differentiated formulations.
Knowledge of oral solid dosage forms and experience in delivering products to global markets.
Understanding of regulatory requirements such as FDA guidelines, cGMP, and cGLP.
Strong analytical skills and practical knowledge of formulation research and development stages.

Behavioral Skills:

Excellent communication and interpersonal skills.
Strong analytical and problem-solving abilities.
Ability to collaborate effectively within cross-functional teams.
Business acumen and decision-making capabilities.
Commitment to learning and coaching others.

About the Department: Integrated Product Development Organisation

Dr. Reddy’s Integrated Product Development Organisation combines deep science and cutting-edge technology to create innovative and affordable therapies for patients worldwide. With a focus on delivering both innovative and generic products, the department handles everything from APIs and formulations to clinical research and regulatory affairs. The team has filed over 1,000 patents and published extensively in peer-reviewed journals, driving the company’s global impact.

Why Join Dr. Reddy’s?

Dr. Reddy’s is a dynamic, science-driven organization that offers personalized growth opportunities and a culture of empathy and innovation. By joining the team, you will contribute directly to advancing healthcare solutions and helping patients around the world live healthier lives.

For more details and to apply, visit: Dr. Reddy's Careers.

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Scientist Differentiated Formulation Development

Job Description

Company Overview

Job Title: Scientist - Differentiated Formulation Development

Job Summary

Key Responsibilities

Qualifications

Skills & Attributes

About the Department: Integrated Product Development Organisation

Why Join Dr. Reddy’s?

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