Process Development Lab

4 days ago

Ahmedabad, Gujarat, India Intas Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Job Overview:

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

Roles & Responsibilities:

Formulation Development and Optimization

  • Lead the development of OSD formulations including immediate-release, sustained-release, and controlled-release dosage forms.
  • Design, develop, and optimize drug formulations based on pre-formulation studies, physicochemical properties, and therapeutic objectives.
  • Troubleshoot formulation issues and implement innovative solutions to enhance product quality and performance.

Project Leadership and Management

  • Manage product development projects to ensure timelines, budgets, and resource allocations are met.
  • Provide technical guidance and oversight to formulation development teams.
  • Lead cross-functional teams from laboratory scale through pilot and commercial scale production.
  • Monitor project progress and adjust plans to achieve milestones.

Regulatory Compliance

  • Ensure all formulations and development processes comply with regulatory standards (FDA, EMA, ICH, GMP).
  • Prepare and review technical documentation including IND, NDA submissions, and stability reports.
  • Interface with regulatory authorities as required to support filings and approvals.

Technology Transfer

  • Oversee smooth transfer of technology from R&D to manufacturing ensuring scale-up consistency.
  • Collaborate with manufacturing teams to resolve technical issues during scale-up and production.

Collaboration & Cross-functional Interaction

  • Work closely with analytical development teams to establish testing methods and product specifications.
  • Collaborate with quality assurance and manufacturing departments to maintain compliance with SOPs and GMP.
  • Partner with clinical and regulatory teams to support clinical trial submissions and regulatory documentation.

Innovation and Process Improvement

  • Keep abreast of industry trends, emerging technologies, and best practices related to OSD and novel drug delivery systems (NDDS).
  • Identify opportunities for product innovation, cost optimization, and process improvements.

Stability & Product Performance

  • Manage stability studies to evaluate shelf-life and product quality.
  • Analyze stability data and recommend formulation modifications as necessary.

Desired Experience & Expertise:

  • 1 to 5 years of experience in product development with a focus on oral solid dosage forms.
  • Strong knowledge of formulation techniques including granulation, compression, coating, and packaging.
  • Proven experience in project management, regulatory submissions, and technology transfer.

Key Skills:

  • Strong expertise in pharmaceutical formulation and pre-formulation studies.
  • Skilled in developing controlled, extended, and immediate-release dosage forms.
  • Thorough knowledge of ICH guidelines, GMP, and regulatory frameworks.

Qualification:

  • M. Pharm (Master of Pharmacy) with relevant functional experience.

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