Formulation Executive

Bioplus Life Sciences; Krishnagiri District; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Bioplus Life Sciences in India is seeking a formulation scientist to lead development from preformulation through pilot scale. You will design strategies, interpret stability data, and drive optimization while integrating IP considerations and regulatory alignment. Mentoring the team and coordinating with R&D, QA, Production, and marketing will be core to the role.

The position emphasizes innovation in drug delivery platforms and ensuring compliance with GMP and data integrity standards.

Qualifications

• Expertise in formulation science and drug delivery design across solid oral, liquid, parenteral, and modified release.
• Experience with pre-formulation and excipient compatibility assessment, and stability data interpretation.
• Familiarity with QbD, CMAs and CPPs, and scale-up from lab to pilot.
• Strong documentation for PD Reports, Stability Protocols and Specifications.
• IP-oriented development with patentable concepts and invention disclosures.
• Regulatory alignment with GMP and data integrity standards.

Responsibilities

• Formulation development from preformulating through lab and pilot scale.
• Design formulation strategies based on literature, patents, and benchmarks.
• Interpret data, identify risks, and drive optimization decisions.
• Prepare core technical documentation (PIF, PDR, stability reports, MFR).
• Coordinate with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing.
• Provide regulatory responses in line with global expectations.
• Mentor formulation team and drive capability building.
• Drive innovation in new drug delivery platforms.

Skills

Formulation science

Drug delivery design

Pre-formulation

Stability data interpretation

QbD development

Documentation skills

IP strategy

Regulatory knowledge

Leadership

Cross-functional collaboration

Job description

Key Responsibilities

• Formulation development (from preformulating through lab and pilot scale) for robust, scalable, and compliant products.
• Design formulation and drug delivery strategies based on literature, patent landscape, and market/innovator benchmarks.
• Interpret preformulating and stability data, identify risks and degradation pathways, and drive science-based optimization decisions.
• Integrate IP thinking into development by identifying white space, generating patentable formulation/process concepts, and supporting invention disclosures.
• Prepare and review core technical documentation (PIF, PDR, stability protocols/reports, specifications, MFR, formulation certificates, costing).
• Coordinate cross-functionally with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing to ensure seamless project execution.
• Provide scientific justifications and responses to regulatory queries in line with global regulatory expectations.
• Mentor and lead the formulation team, ensuring high-quality experimental design, data integrity, and continuous capability building.
• Drive innovation in new drug delivery platforms and differentiated product concepts that support portfolio growth and competitive positioning.

Skills and Competencies

• Formulation science and drug delivery design (solid oral, liquid, parenteral, modified release, platform technologies).
• Pre-formulation and drugexcipient compatibility assessment, including interpretation of physicochemical and stability data.
• Stability study design and data interpretation (ICH conditions, degradation pathways, kinetic understanding).
• QbD-based development, including identification and control of CMAs and CPPs, and scale-up from lab to pilot.
• Strong documentation skills for Product Development Reports, Stability Protocols, Specifications, and MFRs.

Intellectual Property and Innovation

• Integration of IP strategy into formulation development and drug delivery platform design.
• Ability to identify white space, generate patentable concepts, and support invention disclosures with experimental data.
• Understanding of patent landscapes, prior art, and differentiation strategies at formulation and process level.

Regulatory and Compliance Skills

• Preparation of scientific justifications and responses to regulatory queries (USFDA, EMA, MHRA, etc.).
• Familiarity with CMC expectations for formulation development, stability, and product specifications.
• Alignment of development strategies with regulatory and quality standards (GMP, data integrity).

Cross-functional and Business Skills

• Coordination with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing.
• Costing and commercial thinking for new product development (materials, process, scalability).
• Vendor and stakeholder management, including organizing technical seminars and evaluations.

Leadership and People Skills

• Leading and mentoring scientific teams in experimental design, problem-solving, and data interpretation.
• Planning and prioritizing projects, resource allocation, and on-time delivery of development milestones.