Pre Formulations -Research Associate-Shameerpet

SAI Life Sciences; Turakapally; On-site; INR 900,000 - 1,200,000; Full time

Job summary

SAI Life Sciences is seeking an experienced formulation scientist to lead pre-formulation and development activities for solid oral dosage forms. The role involves early phase formulation, stability and solubility work, and coordinating cross-functional teams to meet development timelines.

The candidate will prepare regulatory documents, support technology transfer to GMP sites, and contribute to project discussions with clients, bringing strong analytical and communication skills to the team.

Qualifications

• Sound experience of fundamentals of pre-formulation, preclinical formulation and clinical formulation development.
• Excellent problem-solving and experimental skills.
• Strong written and verbal communication skills.

Responsibilities

• Perform formulation development activities for tablets and capsules to achieve product development timelines.
• Transfer developed products to GMP sites and monitor clinical batch manufacturing.
• Execute preclinical and formulation development work packages.
• Perform solubility, stability, and excipient compatibility studies for new chemical entities.
• Carry out phase-appropriate formulation studies for exploratory projects (API/Blend in capsule/tablet).
• Prepare and review TD, BMR, PDR, risk assessments, and regulatory documents.
• Support regulatory licenses for R&D, clinical, and import/export of drug substances/products.
• Collate data and provide scientific inputs in discussions with clients.
• Prepare reports, SOPs, URS, protocols, and observations in ELN/LNB.
• Collaborate across functions to ensure timely project completion.
• Assist in maintaining/upgrading lab facilities and support teams.

Skills

Pre-formulation fundamentals

Formulation development

Problem solving

Communication skills

Education

M.S. Pharm or M. Pharm in Pharmaceutics

Job description

Role & responsibilities

KEY JOB RESPONSIBILITIES

1. Perform formulation development activities (tablet/capsules) on innovative approach for new chemical entities to achieve product development within stipulated timeline while ensuring good lab and documentation practices.
2. Experience of transferring the developed product to GMP site and monitor clinical batch manufacturing.
3. Execution of preclinical and formulation development work packages.
4. Perform the solubility, stability, excipient compatibilities studies etc., of new chemical entities and apply this knowledge to develop robust product.
5. Operational execution of phase appropriate formulation development studies for exploratory projects i.e. API/Blend in Capsule, API/Blend in bottle, Tablets, Capsules etc. (Early phase formulation development).
6. Prepare and review the Technology Transfer Document (TTD), Batch manufacturing Record (BMR), Product Development Report (PDR), Risk assessment and other regulatory documents for product development.
7. Support and coordinate application of various regulatory licenses required for R&D, clinical and import/export of drug substance and product.
8. Ability to collate and scientifically present the data & observations and provide scientific inputs in discussions with internal or external customer (clients).
9. Prepare reports/presentations/SOPs/guidelines/URS/protocols/reports, follow good documentation practices and record observations in Electronic Lab Notebook (ELN) or manual Lab Notebook (LNB).
10. Collaborate and work across functions and engage in cross departmental activities to ensure timely completion of project as per requirement.
11. Support in developing, maintaining and upgrading the existing lab facility and support facility team to maintain and run the lab efficiently.

Key Competencies (Technical, Functional & Behavioural)

Technical & Functional

• Sound experience of fundamentals of pre-formulation, preclinical formulation and clinical formulation development.
• Excellent problem-solving and experimental skills.
• Strong written and verbal communication skills.

QUALIFICATION AND EDUCATION:

• M.S. Pharm or M. Pharm. In Pharmaceutics or pharmaceutical technology formulations with 5 to 7 years of relevant industrial experience.