Urgent Hiring | Executive/Sr.Executive- F&D (Solid and liquid orals)

Marksans Pharma; Navi Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Marksans Pharma in Navi Mumbai invites applications for Executive/Sr. Executive - FR&D (liquid & solid orals). You will contribute to formulation development of liquid and solid oral dosage forms and support regulatory submissions.

The role involves pre-formulation studies, QbD-based formulation optimization, stability batches, and coordination with Analytical, Regulatory, QA, MS&T to ensure smooth tech transfer and regulatory compliance.

Qualifications

• Formulation and development experience for liquid oral dosage forms in regulatory markets (US/EU/Aus).
• Ability to conduct literature and patent searches and follow regulatory guidances.
• Experience preparing regulatory filings like forms 29/11/RLD import license (as per procedures).
• Procurement of raw materials and packaging materials in consultation with regulatory & purchase teams.
• Conduct pre-formulation studies and QbD-based formulation optimization.
• Manufacture batches for stability studies and perform studies on optimized formulations.
• Review analytical reports and prepare compilation sheets for discussion with supervisors.

Responsibilities

• Coordinate with Analytical, Regulatory, QA, and MS&T teams.
• Prepare technology transfer documents such as MFC, PDR, stability protocols.
• Execute scale-up and exhibit batches as required.
• Address regulatory queries and ensure compliance.

Skills

Formulation & Development

Literature & Patent Search

Regulatory Guidelines Familiarity

Technology Transfer Documentation

Cross-functional Coordination

Job description

We have urgent opening for Executive/ Sr.Executive - FR&D (liquid & solid orals)

JD for Liquid Oral dosage form:

• 1. Experience in formulation & Development of liquid oral dosage form (Solutions & Suspensions) in regulatory market (US/EU/Aus).
• 2. To conduct literature search, patent search of assigned project and should be familiar with regulatory guidances.
• 3. To prepare application for form 29, form 11, RLD import license, form 25 etc.
• 4. To procure raw materials (API/Excipients), Packing material and Innovator samples in consultation with packaging/Regulatory & Purchase department.
• 5. To execute pre-formulation and formulation optimization trials with QbD approach and develop a robust formulation.
• 6. To manufacture batches for stability studies and perform other studies on optimized formulation.
• 7. To review analytical reports and prepare compilation sheet and discuss with superiors.
• 8. To co-ordinate with cross functional departments like Analytical, Regulatory, QA, MS&T etc.
• 9. To prepare Technology transfer documents like MFC, PDR, Stability Protocols, Risk assessment and execute scale up and Exhibit batches.
• 10. Address the regulatory queries.