Role Objective:

To execute hands-on laboratory experiments for the formulation development of sterile liquid injectables, drug-device combination products, and lyophilized formulations. This role focuses on day-to-day experimental execution, cycle optimization, device compatibility evaluation, and operational troubleshooting under the guidance of senior team members to ensure smooth project progression.

KEY RESPONSIBILITIES

- Formulation Execution: Conduct routine laboratory experiments to develop stable, robust sterile liquid injectable dosage forms and troubleshoot technical issues during development.

- Drug-Device Testing: Perform compatibility, functional testing, and quality evaluations for drug-device combination products in alignment with regulatory expectations.

- Lyophilization Support: Execute freeze-drying runs for peptides, proteins, and small molecules, aiding in cycle development, optimization, and characterization.

- Laboratory Operations: Maintain analytical and processing equipment, document experimental protocols, keep meticulous laboratory notebooks, and draft standard operating procedures (SOPs).

- Scale-Up Assistance: Assist senior scientists in technology transfer activities, batch manufacturing records (BMR) preparation, and pilot batch execution.

- Compliance: Ensure strict adherence to cGMP guidelines, safety standards, and internal quality systems in all daily laboratory activities.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

- Interaction with: Senior Scientists, Analytical R&D;, Quality Assurance,



and Packaging Development.

- Nature of Interaction: Daily routine work alignment, reporting experimental results, sample handover for analytical testing, and technical data discussion.

Type of Interaction: External
- Interaction with: Raw material suppliers and analytical/equipment vendors.

- Nature of Interaction: Procurement of lab samples/reagents, routine equipment calibration support, and gathering technical product specifications.

JOB REQUIREMENTS

Skilled Experience and Relevant Skills

- Experience: 2 to 5 years of relevant hands-on experience in sterile injectable formulation R&D.;

- Technical Expertise

1. Operational understanding of aseptic processing techniques, sterile compounding, filtration, and lyo cycle monitoring.

2. Basic familiarity with ICH guidelines, GLP/cGMP protocols, and device compatibility metrics.

- Skills

1. Hands-on formulation development of sterile liquid injectables and basic troubleshooting capabilities.

2. Exposure to drug-device combination product testing, device functionality, and compatibility setups.

3. Practical experience operating lyophilizers and supporting freeze-drying cycle optimization for small molecules, peptides, or proteins.

Academic Qualifications & Certifications
- Educational Qualification: M.Pharm / B. Pharm / M.Sc. in Pharmaceutics, Chemistry, or relevant Life Sciences.

DEI Statement: USV provides equal employment opportunities to all applicants based on merit, without discrimination of any kind

📌 Executive- Formulation & Development (Sterile) (Maharashtra)
🏢 USV
📍 Maharashtra