PDL

Alkem Laboratories; Navi Mumbai; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Alkem Laboratories in Navi Mumbai seeks a formulation development specialist with 3–5 years’ experience across tablet, liquid, capsule, and dosage forms for regulatory markets. The role encompasses vendor development, tech transfer, pre-formulation, and DoE-based optimization to support scale‑up and process control.

You will work with cross-functional teams, compile lab data, and ensure compliance with global regulatory guidelines while maintaining meticulous documentation and lab records.

Qualifications

• Experience in formulation development for regulatory market.
• Experience in vendor development and technology transfer documentation.
• Familiarity with DoE, OFAT and design of experiments for process optimization.

Responsibilities

• Alternate vendor development and troubleshooting for oral dosage forms.
• Support for technology transfer and development documentation.
• Provide inputs for DoE-based optimization and scaling up of processes.
• Stability data generation and review for lab-scale batches.
• Maintain lab notebooks and development related documents.
• Conduct literature searches and apply findings to product development.
• Handle pre-formulation studies and initial process development.
• Ensure compliance with safety and environmental guidelines.

Skills

Vendor development

Regulatory knowledge

QbD software

DoE studies

Data analysis

Documentation

Literature search

Pre-formulation

Stability testing

Education

M Pharm

Pharmaceutics

Tools

QbD software

MS Office

Job description

Role & responsibilities

1. Responsible for Alternate vendor development and commercial troubleshooting of different oral dosage forms (Tablet/liquid/capsule/immediate release/modified release dosage forms) for regulatory market.
2. Responsible for alternate vendor development activities, support for technology transfer and preparation of documents during development.
3. Responsible for providing inputs for designing QbD based experimentation strategy for formula and process optimization (including OFAT and DoE studies, identification of critical formulation and process variables, etc.) DoE based Design suggestions, data modelling and data analysis, interpretation of results and provide way forward. Providing inputs for scaling up of the process variables and preparation of control strategy for process control

4. Responsible for market extension activities.

5. Lab trial data compilation and discussion with group leader for new trials planning and decision making.

6. Online completion of lab notebook and development related documents.

7. Literature search and implementation in product development.

8. Application of form-29 and form-11 for assigned projects.

9. Responsible for pre-formulation study/process development.

10. Stability charging of lab scale batches with monitoring and review of stability data.

11. Keep the work area clean and the laboratory under controlled temperature.

12. Understand the safety and environmental aspect.

13. Analyse the formulation strategy, efficiency, working relations and cross-functional issues in R&D

14. Proactive readiness for material /change part arrangement.

1. Try to solve the problem related to alternate vendor product development, process development and discuss with group leader.

Preferred candidate profile

3 to 5 years with exposure to different types of oral dosage forms (Tablet/liquid/capsule/immediate release/modified release dosage forms) for regulatory market.

Functional Skills :( List the skills required)

1. Experience on various formulation development like immediate release/extended release/delayed release/ liquid dosage forms for regulatory market.

2. Experience on various equipment used in formulation development, QbD software.

3. Experience in technology transfer from R&D to pilot scale/commercial scale.

4. Knowledge about US FDA/EU/TGA and other regulated market guidelines.

5. Good oral and written communication skills

6. Adequate knowledge of Microsoft office (MS-Word, MS-Power Point and MS-Excel).

Qualification:

• Basic: M Pharm
• Professional: Pharmaceutics
• Desired: Well acquainted with QbD approach and primary understanding of design of experiment software, process scale up from lab to pilot to commercial scale.