Lead Formulation Research & Development (Injectables & Pen Devices)

Purpose

Lead the Formulation R&D function for injectables and pen devices, driving innovation, regulatory compliance, and product development to ensure the successful launch of high-quality, stable, and patient-friendly formulations.

Key Responsibilities

- Develop and execute formulation strategies for injectables (vials, prefilled syringes, lyophilized products) and pen devices.

- Oversee pre-formulation studies, formulation development, process optimization, and scale-up.

- Ensure compliance with global regulatory requirements (FDA, EMA, MHRA, WHO, DCGI).

- Collaborate with CMC (Chemistry, Manufacturing & Controls), Analytical R&D, Regulatory Affairs, and Quality teams for seamless product development.

- Drive innovation in novel drug delivery systems, biosimilars, and combination products.

- Provide technical leadership in stability studies, packaging selection, and extractables & leachables studies.

- Evaluate and implement advanced technologies for long-acting injectables, depot formulations, and targeted delivery systems.

- Troubleshoot formulation challenges related to stability, solubility, and compatibility with devices.

- Lead technology transfers from R&D to manufacturing at pilot and commercial scale.

- Manage interactions with regulatory agencies for product filings, IND/NDA submissions, and query resolution.

Key Performance Indicators (KPIs)

- Successful development and regulatory approval of new injectable & pen device formulations.

- Adherence to timelines for product development milestones.

- Stability and bioavailability optimization for formulations.

- Regulatory approval success rate and first-cycle approval.

- Efficiency in technology transfer and scale-up to manufacturing.

- IP creation (patents, novel formulation technologies).

Key Relationships

- Regulatory Affairs, Quality Assurance (QA), Analytical R&D, CMC teams.

- Manufacturing, Supply Chain, and Packaging Development.

- Business Development, Licensing, and External Partners.

- Regulatory Agencies (FDA, EMA, MHRA, DCGI, etc.).

Scope of Authority

- Decision-making authority on formulation design, process development, and troubleshooting.

- Approval of technology transfer and scale-up strategies.

- Final say in technical documentation and regulatory submission data.

Skills and Competencies

- Expertise in injectables (vials, prefilled syringes, lyophilized products) and pen device formulations.

- Strong knowledge of sterile processing, aseptic techniques, and cGMP guidelines.

- Experience in regulatory filings (IND, NDA, ANDA, BLA) and clinical phase development.

- Analytical problem-solving skills for stability and formulation challenges.

- Leadership in cross-functional collaboration and project management.

- Experience with QbD (Quality by Design) and risk-based approaches.

Challenges/Complexities

- Ensuring compatibility of formulations with pen devices and injection systems.

- Regulatory challenges in new product approvals and compliance with evolving guidelines.

- Scaling up from lab-scale to commercial manufacturing without compromising stability and quality.

- Managing timelines for global regulatory submissions.

Reporting Structure

Reports to the Executive Vice President

Decision-Making Scope

- Selection of formulation strategy and excipient compatibility.

- Approval of stability studies, scale-up processes, and technical reports.

- Budget and resource allocation for formulation projects.

Required Collaboration

- Works closely with Analytical R&D, Manufacturing, Regulatory Affairs, and Business Development.

- Engages with external partners, CDMOs, and regulatory agencies.