As a Formulator, you will manage the end-to-end formula and process development for products, adhering to Good Laboratory Practices (GLP). This role requires keen attention to data quality, regulatory standards, and budget constraints to deliver robust pharmaceutical products.

Key Accountabilities

1. Pharma Literature Review:
   • Gather insights from USFDA and other regulatory sources to guide product development.
2. Document Submission:
   • Compile and submit stage-gate documents to cross-functional teams (CFT) for plant batch execution.
3. Pre-Formulation Studies:
   • Conduct reference product characterization and optimize formulas to develop robust pharmaceutical products.
4. Material Procurement:
   • Collaborate with supply chain management to source raw materials (RM), packaging materials (PM), and filters for development and submission batches.
5. Regulatory Compliance:
   • Perform R&D trials, execute regulatory submission batches, and prepare data for successful filings.
6. Deficiency Response Support:
   • Generate required data at R&D or the manufacturing unit to address regulatory queries and secure product approval.

Education and Qualifications

• Master’s Degree in Pharmacy (Specialization in Pharmaceutics).

Relevant Work Experience

• Minimum 4 years of experience in R&D, preferably in injectables.

Key Skills and Competencies

Core Competencies

• Collaborate to Succeed: Work effectively with cross-functional teams.
• Innovate to Excel: Utilize innovative solutions for robust product development.
• Perform with Accountability: Deliver on commitments with precision and integrity.
• Lead with Empathy: Build strong interpersonal relationships.
• Act with Agility: Adapt quickly to dynamic work requirements.

Technical Expertise

• Strong domain knowledge in pharmaceutical product development.
• Experience in regulatory data preparation and submissions.
• Proficiency in managing R&D and manufacturing processes.

Application Link