Formulation Development Pharmacist R and D Scientist Generic Pharmaceu

Food Safety Consulting Services, Acts Biotech; Chennai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Food Safety Consulting Services in Chennai seeks a Formulation Development Pharmacist / R&D Scientist to build its R&D function for generic pharmaceutical formulations. You will develop tablets and oral liquids, oversee preformulation, analytical testing, stability, and technology transfer to manufacturing.

The role requires 3–5 years’ hands-on experience and preferably a Ph.D. or an M.Pharm in pharmaceutics, with strong regulatory documentation and GMP compliance skills.

Qualifications

• Ph.D. or M.Pharm with focus on pharmaceutics, drug delivery or related area.
• 3–5 years hands-on experience in pharmaceutical formulation development or R&D.
• Experience with generic tablet formulations, preformulation and stability studies.
• Experience preparing development reports and regulatory documentation.

Responsibilities

• Develop and optimise generic formulations, initially tablets.
• Coordinate preformulation, excipient selection and dissolution testing.
• Plan stability studies and coordinate analytical testing with QC.
• Prepare formulation development reports and tech documentation.
• Support scale-up, process transfer and regulatory submissions.
• Ensure GMP-compliant documentation and QA coordination.

Skills

Formulation development

R&D

Scale-up knowledge

Analytical testing

Regulatory documentation

GMP awareness

Troubleshooting

Education

Ph.D. in Pharmaceutics or related field

M.Pharm in Pharmaceutics or related field

Job description

Job Title: Formulation Development Pharmacist / R&D Scientist Generic Pharmaceutical Formulations

Company Name: Food Safety Consulting Services
Location: Chennai, Tamil Nadu
Department: Research & Development / Formulation Development
Employment Type: Full-time
Work Mode: On-site
Experience: 3–5 years
Educational Qualification: Ph.D. or M.Pharm in Pharmaceutics, Pharmaceutical Sciences, Industrial Pharmacy or a closely related specialisation.

About the Company

Food Safety Consulting Services is establishing a pharmaceutical formulation manufacturing business focused on developing and manufacturing quality generic medicines for the Indian market and international export markets.

We are seeking a technically competent and research-oriented Formulation Development Pharmacist / R&D Scientist to help establish our pharmaceutical R&D function, develop generic formulations, and support the transition of products from laboratory development to commercial manufacturing.

This is an opportunity to join a growing pharmaceutical business at an early stage and contribute to product development, technical documentation, process optimisation and commercialisation.

Job Summary

The selected candidate will be responsible for developing and optimising generic pharmaceutical formulations, conducting preformulation studies, preparing development documentation, coordinating analytical testing and stability studies, and supporting scale-up and technology transfer to commercial production.

The initial focus will be on conventional oral solid dosage forms, particularly tablets. Experience in oral liquid formulations, including syrups and suspensions, will be an advantage as the product portfolio expands.

Key Responsibilities

1. Formulation Development and Research

• Develop and optimise generic pharmaceutical formulations, initially focusing on conventional immediate-release tablets.
• Conduct preformulation studies and evaluate the physicochemical properties of active pharmaceutical ingredients (APIs) and excipients.
• Select suitable excipients, establish formulation compositions and assess compatibility, manufacturability and product performance.
• Develop formulations for selected generic medicines, including paracetamol tablets, in accordance with the approved product development plan.
• Support the future development of oral liquid formulations, including cough syrups and suspensions, where appropriate.
• Troubleshoot formulation problems such as poor powder flow, sticking, capping, inadequate tablet hardness, disintegration failures, dissolution issues and content uniformity variations.
• Evaluate scientific literature, pharmacopoeial requirements and relevant reference products to guide formulation development.

2. Process Development and Scale-Up

• Develop and optimise manufacturing processes, including blending, granulation, drying, compression and coating, where applicable.
• Establish preliminary process parameters and recommend suitable in-process controls.
• Coordinate laboratory and pilot-scale trials and support technology transfer to commercial manufacturing.
• Collaborate with production personnel to resolve formulation and process-related problems during scale-up and commercial batches.
• Support process validation and continued process improvement in coordination with the Quality Assurance and Production departments.

3. Analytical Testing and Stability Studies

• Coordinate with the Quality Control laboratory for assay, dissolution, disintegration, content uniformity and other relevant product tests.
• Review and interpret analytical results to support formulation optimisation.
• Plan and coordinate stability studies in accordance with applicable Indian regulatory requirements and relevant destination-market requirements.
• Investigate stability-related issues, including changes in assay, dissolution, appearance, moisture content and other critical product characteristics.
• Coordinate analytical method development, verification or validation with the QC team or an appropriate external laboratory.
• Support comparative dissolution studies and other product-performance evaluations where required.

4. Regulatory and Technical Documentation

• Prepare formulation development reports, master formula records, batch manufacturing instructions, product specifications and supporting technical documentation.
• Maintain laboratory notebooks, experimental data, development records and change histories.
• Support preparation of product dossiers and technical documents required for Indian product permissions and export registrations.
• Coordinate with Regulatory Affairs, QA and external consultants regarding applicable CDSCO, State Licensing Authority and destination-country requirements.
• Identify product-specific requirements for bioequivalence studies, comparative dissolution studies or other evidence, and coordinate with qualified external organisations where necessary.

5. Raw Material and Supplier Evaluation

• Evaluate APIs and excipients in coordination with QA and QC.
• Review API and excipient specifications, certificates of analysis and technical documentation.
• Assist in identifying and technically evaluating reliable suppliers and contract manufacturers.
• Support assessment of raw materials, packaging materials and alternative suppliers.
• Help assess the technical feasibility and cost-effectiveness of proposed generic products.

6. GMP and Quality Compliance

• Ensure that development work is accurately documented and performed in accordance with applicable GMP, laboratory safety and data-integrity requirements.
• Work closely with QA, QC and Production to ensure that products are developed with appropriate quality controls.
• Participate in investigations involving formulation failures, deviations, out-of-specification results and stability problems.
• Support technical reviews, audits and corrective and preventive actions relevant to formulation development.
• Contribute to establishing appropriate R&D procedures, documentation practices and product development workflows.

Educational Qualifications

• Preferred: Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Industrial Pharmacy, Drug Delivery or a closely related pharmaceutical specialisation.
• Also eligible: M.Pharm in Pharmaceutics, Industrial Pharmacy or a closely related specialisation.
• Candidates must possess qualifications from recognised institutions.
• Preference will be given to candidates with research experience directly relevant to pharmaceutical formulation development and generic medicines.

Experience Required

• 3–5 years of hands‑on experience in pharmaceutical formulation development or pharmaceutical R&D.
• Practical experience in developing conventional generic tablet formulations is strongly preferred.
• Experience in preformulation studies, excipient selection, formulation optimisation, dissolution studies and stability testing.
• Experience in preparing formulation development reports, master formula records and technology-transfer documentation.
• Exposure to pilot-scale or commercial-scale manufacturing is highly desirable.
• Experience in oral liquid formulations, including syrups and suspensions, will be an added advantage.
• Experience supporting product dossiers, regulatory submissions or export product registrations will be advantageous.
• Candidates with a Ph.D. should demonstrate practical formulation development capabilities in addition to academic or research experience.

Technical Skills

• Strong understanding of pharmaceutical preformulation and formulation development.
• Knowledge of APIs, excipients, compatibility studies and critical quality attributes.
• Understanding of granulation, blending, tablet compression and other relevant manufacturing processes.
• Knowledge of dissolution, disintegration, assay, content uniformity and stability studies.
• Familiarity with GMP, pharmaceutical documentation, data integrity and quality systems.
• Ability to interpret scientific literature and translate research findings into practical formulation development.
• Strong analytical thinking, troubleshooting, scientific writing and problem-solving skills.

Preferred Candidate Profile

• A practical, scientifically oriented professional capable of helping establish an R&D function in a growing pharmaceutical business.
• Able to work independently while coordinating with QA, QC, Production and Regulatory Affairs.
• Willing to contribute to both experimental development and technical documentation.
• Commercially aware and able to balance product quality, manufacturability, regulatory compliance and development costs.
• Comfortable working in a start-up environment with evolving product development priorities.

What We Offer

• An opportunity to establish and develop the formulation R&D function of a growing pharmaceutical business.
• Exposure to generic medicine development for domestic and international markets.
• Opportunities to contribute to product selection, formulation development, scale-up and commercialisation.
• Professional growth and remuneration commensurate with qualifications, relevant experience and technical expertise.