PDL OSD (Executive )

The Product Development Leader (PDL) for Oral Solid Dosage (OSD) will play a pivotal role in leading the development of oral solid dosage forms (tablets, capsules, etc.) from early-stage formulation to commercialization. This position requires strong leadership in overseeing product development strategies, managing cross-functional teams, ensuring timely project execution, and ensuring compliance with regulatory requirements. The PDL will work closely with various internal departments such as formulation development, analytical services, regulatory affairs, and manufacturing.

Role & Responsibilities:

• Formulation Development and Optimization:

Lead the formulation development for OSD products, including immediate-release, sustained-release, and controlled-release formulations.

Design, develop, and optimize drug formulations based on pre-formulation studies, physicochemical properties, and therapeutic needs.

Troubleshoot formulation issues and implement innovative solutions to improve product quality and performance.

• Project Leadership and Management:

Manage product development projects, ensuring adherence to timelines, budgets, and resources.

Provide technical guidance and oversight to formulation development teams.

Lead cross-functional teams to drive development from laboratory scale to pilot and commercial scale.

Monitor and report on project progress, adjusting plans as needed to meet milestones.

• Regulatory Compliance:

Ensure formulations and development processes comply with regulatory requirements (e.g., FDA, EMA, ICH, GMP).

Prepare and review technical documentation, including IND, NDA submissions, stability studies, and other regulatory documents.

Interface with regulatory bodies as required and support the preparation of regulatory filings.

• Technology Transfer:

Oversee technology transfer activities from R&D to manufacturing, ensuring smooth transition and scale-up.

Work closely with manufacturing teams to resolve technical issues and ensure consistency during scale-up.

• Collaboration & Cross-functional Interaction:

Collaborate with analytical development teams to establish appropriate testing methods and specifications.

Work closely with quality assurance and manufacturing to ensure compliance with SOPs and GMP standards.

Collaborate with clinical and regulatory teams to develop and submit data for clinical trials and regulatory filings.

• Innovation and Process Improvement:

Stay current with industry trends, emerging technologies, and best practices related to OSD formulations and NDDS.

Identify opportunities for process improvements, cost reductions, and product innovation.

• Stability & Product Performance:

Oversee stability studies and product performance evaluation to determine shelf-life, formulation stability, and product quality. Analyse and interpret data from stability studies and recommend formulation adjustments as needed.

Desired Experience & Expertise:

• At least 1-5 years of experience in product development, with a focus on oral solid dosage (OSD) forms.
• Strong knowledge of formulation development techniques, including granulation, compression, coating, and packaging.
• Experience with advanced drug delivery systems (NDDS) is a plus.
• Demonstrated experience in project management, regulatory submissions, and technology transfer.

Key Skills:

• Strong understanding of pharmaceutical formulation, pre-formulation studies, and drug delivery systems.
• Expertise in developing controlled release, extended release, and immediate-release formulations.
• In-depth knowledge of ICH, GMP, and regulatory guidelines.

Qualification : M. Pharm with relevant function experience