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Formulator

4+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: M. Pharm 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

Job Details

Position: Product Development Scientist
Division: Integrated Product Development (IPD)
Department: IPD
Employment Type: Permanent
Location: Vikhroli


Job Purpose

To execute end-to-end formula and process development for pharmaceutical products while adhering to good laboratory practices, ensuring robust quality, and meeting regulatory, budgetary, and timeline requirements.


Key Accountabilities

1. Literature Review

  • Collate and review pharmaceutical literature, including guidelines from USFDA, to leverage insights during product development.

2. Documentation for Stage Gates

  • Submit stage gate documents to cross-functional teams (CFT) based on development trial data to facilitate batch execution at the plant.

3. Pre-Formulation Studies

  • Conduct pre-formulation studies by characterizing the reference product and optimizing formulas to ensure the development of robust products.

4. Procurement Coordination

  • Submit indents through supply chain management for procuring filters, raw materials (RM), and packaging materials (PM) required for product development and submission batches.

5. Regulatory Submission

  • Generate regulatory submission data by conducting R&D trials and executing submission batches at the unit to enable successful filings.

6. Deficiency Response Support

  • Provide support for deficiency responses by generating data at R&D/unit required for product approval.

Education Qualification

  • Master in Pharmacy (Specialization in Pharmaceutics)

Relevant Work Experience

  • 4 years of experience in R&D (preferably in injectables).

Key Competencies/Skills

  1. Collaborate to Succeed: Work effectively with cross-functional teams to achieve product development goals.
  2. Innovate to Excel: Employ innovative methods to enhance formula and process development.
  3. Perform with Accountability: Take responsibility for project timelines, regulatory compliance, and product quality.
  4. Lead with Empathy: Foster a collaborative and inclusive environment within teams.
  5. Act with Agility: Adapt to changing regulatory requirements, project timelines, and development challenges.
  6. Strong Domain Knowledge: Expertise in pharmaceutical formulation, particularly for injectables.
  7. People Management: Guide and mentor team members to enhance their performance and skills.

Summary

This position plays a critical role in developing robust pharmaceutical products. The ideal candidate will leverage technical expertise and cross-functional collaboration to ensure efficient product development, compliance with regulatory standards, and successful market entry.