Formulation Scientist - Differentiated Formulations

Dr.Reddy's

2+ years

Not Disclosed

Hyderabad

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/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 Description

Dr. Reddy’s Laboratories Ltd. is a global leader in the pharmaceutical industry, with a presence in 66 countries and a workforce of over 24,000 employees. Since its founding in 1984, Dr. Reddy’s has focused on delivering affordable, innovative medicines through a combination of deep scientific expertise, sustainable practices, and a commitment to corporate governance. The company's goal is to provide access to high-quality healthcare for over 1.5 billion patients by 2030. Dr. Reddy’s is committed to fostering an inclusive and diverse workforce, emphasizing merit and diversity in every aspect of its operations.

Job Description

Position: Scientist - Differentiated Formulation Development

Dr. Reddy’s is seeking a dynamic and experienced Scientist to join the Differentiated Formulation Development team. This role involves overseeing the development of differentiated product formulations, managing the successful completion of Proof of Concept (PoC), pilot and pivotal bio studies, and scaling up the formulation process from bench scale to commercial level.

Roles & Responsibilities:

Formulation Development: Oversee the development of robust, stable formulations for global markets, ensuring they meet regulatory requirements and industry standards.
Preformulation and Characterization: Collaborate with the Strategy Design team to prioritize product criticality and plan preformulation studies. Coordinate reverse engineering studies and comprehensive characterization with the preformulation team.
Data Analysis and Strategy: Review and analyze data to identify potential formulation challenges. Devise contingency strategies and develop product milestones for formulation experiments.
Pilot and Exhibit Batch Processes: Facilitate pilot and exhibit batch processes, process optimization trials, and collaborate on filing preparation for the development of bioequivalent drug products.
Documentation and Compliance: Prepare and review experimental documentation, including batch plans, protocols, and sampling plans. Ensure adherence to regulatory standards and company procedures (SOPs).
Regulatory Response: Address regulatory queries related to formulation development and contribute to the creation of robust regulatory strategies for drug products.
Laboratory Maintenance and Safety: Oversee laboratory and equipment maintenance, ensuring implementation of company safety standards. Prepare and review SOPs related to formulation development.

Qualifications

Educational Qualifications:

Master’s or Ph.D. in Pharmaceutics or related field.

Experience:

M. Pharm with 2+ years of experience or Ph.D. in Differentiated Formulation Development.

Skills & Expertise:

Technical Skills:

Experience in end-to-end product development and troubleshooting in differentiated formulation development for global markets.
Proven track record in developing oral solid dosage forms, with 3-4 successful product launches for global markets.
Strong theoretical and practical understanding of formulation research and development, including analytical evaluation and characterization tools.
Familiarity with process controls, equipment scale-ups, and regulatory guidelines (FDA, cGMP, cGLP).
Comprehensive knowledge of preclinical/clinical studies, regulatory aspects, and intellectual property laws.

Behavioral Skills:

Excellent communication, interpersonal, and analytical skills.
Strong business acumen and decision-making abilities.
Ability to collaborate effectively with cross-functional teams.
Committed to coaching and developing team capabilities.

About the Department

Integrated Product Development Organisation is dedicated to bringing innovative, accessible, and affordable therapies to patients worldwide. With end-to-end capabilities in API, formulations, clinical development, intellectual property, and regulatory affairs, the department is responsible for serving over 55 global markets. Dr. Reddy’s robust R&D team includes over 200 scientists and experts, with more than 1,000 products in the pipeline, as well as 1,071 patents filed and over 1,000 peer-reviewed publications.

Benefits Offered

Competitive benefits including joining and relocation support, medical coverage for you and your family, life coverage, maternity and paternity benefits, and professional development opportunities.

Work Culture

Dr. Reddy’s fosters a culture driven by the belief that "Good Health Can’t Wait." This guiding principle shapes the company's commitment to delivering impactful healthcare solutions. The environment promotes teamwork, innovation, and personal growth, where diverse talents are united by a shared purpose. Employees thrive in a culture of empathy, dynamism, and collaboration.

For more information, visit Dr. Reddy’s Careers website.

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Formulation Scientist - Differentiated Formulations

Job Description

Company Description

Job Description

Roles & Responsibilities:

Qualifications

Skills & Expertise:

About the Department

Benefits Offered

Work Culture

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