Research Associate I - Formulation R&D (OSD)

Why This Role Matters

The Research Associate I – Formulation R&D (OSD) plays a critical role in developing robust and scalable oral solid dosage (OSD) formulations from concept to commercialization. This position supports end-to-end product development, ensuring scientific rigor, regulatory compliance, and successful technology transfer to manufacturing sites.
By applying Quality by Design (QbD) principles, conducting Design of Experiments (DoE), and ensuring cGMP and ICH compliance, the role directly contributes to high-quality pharmaceutical product development for domestic and regulated markets.

Job Description

The selected candidate will be responsible for developing OSD formulations across all stages including pre-formulation studies, laboratory development, scale-up, and technology transfer. The role involves experimental design, documentation preparation, stability support, validation coordination, and regulatory submission assistance.
Based in Hyderabad, this permanent position is ideal for candidates with hands-on formulation experience and exposure to statistical tools used in pharmaceutical development.

Key Features of the Role

• Position: Research Associate I – Formulation R&D (OSD)
• Location: Hyderabad, Telangana
• Experience Required: 1–4 years
• Employment Type: Permanent
• Function: Formulation Research & Development
• Market Exposure: Domestic & Regulated Markets

Key Responsibilities

• Develop Oral Solid Dosage (OSD) formulations from pre-formulation to scale-up
• Conduct DoE and QbD-based formulation optimization studies
• Perform granulation, compression, and coating activities
• Support technology transfer to manufacturing units
• Author Product Development Reports (PDR) and CMC documentation
• Assist in regulatory submission documentation for domestic and regulated markets
• Support stability studies and validation activities
• Ensure compliance with cGMP, ICH guidelines, and data integrity requirements
• Coordinate cross-functionally with QA, QC, Regulatory, and Manufacturing teams

Required Qualifications

Educational Background:
• M.Pharm
• B.Pharm
• M.Sc (Relevant specialization)

Experience:
• 1–4 years of experience in OSD formulation development

Technical Skills:
• Hands-on experience in granulation (wet/dry), compression, and coating processes
• Exposure to statistical software such as Design-Expert or Minitab
• Strong understanding of QbD and DoE principles
• Knowledge of cGMP, ICH guidelines, and data integrity practices
• Experience in documentation for PDR and CMC modules

Nice to Have:
• Modified Release (MR) / Sustained Release (SR) formulation expertise
• Bioequivalence (BE) study support exposure
• Experience in tech transfer to regulated manufacturing plants

Soft Skills:
• Strong analytical and problem-solving ability
• Technical documentation proficiency
• Cross-functional collaboration skills
• Ability to manage multiple development projects

Salary Insights

Compensation will be aligned with industry standards for Research Associate roles in Formulation R&D and may vary based on hands-on expertise and exposure to regulated markets.

FAQs

Q1. Is regulated market experience mandatory?
Exposure is preferred but not mandatory for all candidates.

Q2. Is hands-on OSD processing required?
Yes, practical experience in granulation, compression, and coating is essential.

Q3. Is statistical software knowledge necessary?
Yes, exposure to Design-Expert or Minitab is expected.

Q4. Does the role involve regulatory documentation?
Yes, preparation of PDR and CMC documentation is a key responsibility.

Q5. Is this a permanent position?
Yes, this is a permanent role based in Hyderabad.

Application Tip

• Clearly mention OSD formulation experience
• Highlight DoE/QbD project work
• Include statistical software exposure
• Showcase regulatory documentation experience
• Mention any MR/SR formulation or BE support exposure