Advanced Researcher Formulation Development Soft Gelatine

Sri Indrakshi Informatics; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sri Indrakshi Informatics in Hyderabad is seeking an Advanced Researcher in Formulation Development with deep Soft Gelatine expertise. You will lead R&D on gels, manage design and scale-up, and mentor junior scientists in a regulatory, cgmp environment for global markets.

Your role focuses on shell/formulation optimization, QbD-driven development, and cross-functional collaboration with RA, QA, and Manufacturing to drive successful tech transfers and product launches.

Qualifications

• 8+ years in formulation development with hands-on Soft Gelatine capsule work.
• Strong knowledge of QbD, formulation design, and regulatory expectations.
• Experience writing PDRs and compiling development reports.
• Familiarity with IVIVC/IVIVR and risk assessment (FMEA).
• Ability to lead cross-functional teams and mentor scientists.
• Experience with amorphization tech and containment for HPAPIs.

Responsibilities

• Lead Soft Gelatine and other dosage form development for global markets.
• Design and execute pre-formulation and formulation experiments under QbD.
• Drive shell, fill formulation, and process development for gels.
• Coordinate scale-up, exhibit, and manufacturing troubleshooting.
• Review docs per cgmp/ICH; ensure data integrity for audits.
• Prepare PDR, FMEA, and project reports for management/regulatory.
• Mentor Scientists and Sr. Scientists; provide technical guidance.
• Support regulatory responses and tech transfer with RA/QA/Manufacturing.
• Evaluate new tech/equipment for amorphization and process improvements.
• Represent formulation in project reviews and risk mitigation planning.

Skills

Soft Gelatine encapsulation

Quality by Design (QbD)

PDR writing

IVIVC/IVIVR analysis

Cross-functional leadership

Mentorship

Tools

HME

Spray Drying

Pelletization

Job description

Role & responsibilities

I. Title

Job: Advanced Researcher Formulation Development (Soft Gelatine)

II. Position in the organizational structure

Immediate Supervisor: POD Lead Formulation Development

III. Main objective

To lead and drive advanced research and development activities in formulation development, with specialized expertise in Soft Gelatine (Soft gel) capsule technology, novel formulations, complex generics and generic products. The role owns the design, experimentation, scale-up, and continuous improvement of new and existing products as per Quality by Design (QbD), while providing technical mentorship to junior scientists and driving cross-functional project delivery.

IV. Key responsibilities of the Role:

• 1. Lead formulation and process development activities for Soft Gelatine capsules, along with other solid dosage forms (tablets, capsules) and delivery forms (liquids, powders, semi-solids) for Global regulated markets.
• 2. Independently design and conduct advanced pre-formulation and formulation development experiments using a QbD approach; evaluate stability data and finalize formulation composition for complex and novel products.
• 3. Drive Soft Gelatine encapsulation technology development including shell formulation, fill-shell compatibility, plasticizer selection, cross-linking behaviour, and gelatin / non-gelatin shell optimization.
• 4. Lead cross-functional activities at the plant for scale-up, exhibit batches, and commercial batches, including troubleshooting of manufacturing and process-related issues for assigned projects.
• 5. Review and approve documentation as per cGMP and ICH guidelines, including product development protocols, stability study protocols and reports, and SOPs; ensure maintenance of critical data records for regulatory audits.
• 6. Prepare and review product development reports (PDR), risk assessment reports (FMEA), and compile project reports for management and regulatory submissions.
• 7. Provide technical guidance, training, and mentorship to Scientists / Sr. Scientists in the team, supporting their capability development.
• 8. Support responses to regulatory queries (RTQ) and interact with cross-functional teams (RA, QA, Manufacturing) to ensure successful technology transfer.
• 9. Evaluate and implement new technologies / equipment for Amorphization and Soft Gel manufacturing to improve efficiency and product quality.
• 10. Represent the formulation team in project review meetings and provide technical inputs for project planning and risk mitigation.

V. Essential Skills & Experience:

• 1. Professional experience: Minimum 8 years of overall experience in formulation development, of which at least 4 years should be dedicated hands-on experience in Soft Gelatine (Softgel) capsule formulation and manufacturing technology.
• 2. Strong expertise in pharmaceutical formulation principles, techniques, and technologies, including scale-up in a regulatory and cGMP framework, for global regulated markets (US / EU / ROW).
• 3. Advanced knowledge and hands-on experience in Soft Gelatine Encapsulation Technology - shell / fill formulation, plasticizer systems, cross-linking, and dissolution behavior of soft gels.
• 4. Excellent communication and stakeholder management skills, with demonstrated ability to lead cross-functional teams and mentor junior scientists.
• 5. Strong expertise in QbD, PDR writing, IVIVC / IVIVR, risk assessment (FMEA), and data compilation & analysis.
• 6. Hands-on experience in Amorphization Technologies such as HME / Spray Drying / Pelletization, and experience working with High Potent APIs under containment.
• 7. Prior experience handling regulatory audits / inspections and responding to regulatory queries is preferred.
• 8. Exposure to technology transfer and scale-up from lab to commercial manufacturing scale.

VI. Interrelations and subordination of the job

Internal: POD Lead - Formulation Development; interacts with all employees in the company considering the job description; mentors Scientist / Sr. Scientist team members.

External: Liaise with manufacturers, raw material / shell suppliers, equipment vendors and/or their representatives in connection with the work performed.