Lead, mentor, and inspire the Formulation and Analytical teams to drive excellence in product / drug development activities.
Collaborate strategically with cross-functional teams to achieve critical milestones and ensure on-time delivery of key objectives.
Provide visionary leadership and mentorship to middle management, guiding them on generic / innovative development projects.
Ensure the successful execution and timely delivery of product / drug development activities, along with the preparation of comprehensive development reports for regulatory submissions.
Empower and support middle management in achieving technical and organizational goals.
Drive and coordinate efforts with cross-functional teams, including Tech Transfer, Production, Quality Assurance, and Quality Control, to guarantee a seamless transition from lab-scale development to commercial manufacturing.
Offer strategic technical support to Regulatory Affairs and Quality Assurance teams for efficient product registration and compliance.
Oversee and lead all aspects of Product Development Project Management, ensuring progress on critical milestones and innovative solutions.
Lead global business initiatives e.g. Nitrosamine & Scientific Publishing
Ensure compliance with statutory requirements and fulfill responsibilities associated with the role of Occupier as defined under the Factories Act.
Oversee all aspects of operations, including product / drug development, quality, maintenance, and people, ensuring compliance with regulations like GMP and safety standards.
The Site Head also manages the site's budget, develops and implements operational strategies.
How you’ll spend your day
Review, Approve and lead the product / drug development strategies, specifications, master formulae, development reports, and validation protocols.
Inspire and lead formulation & analytical teams to excel in product development projects.
Oversee nitrosamine and scientific publishing activities to drive growth.
Drive cross-departmental collaborations, ensuring smooth product scale-up from the development stage to commercial manufacturing.
Act as a strategic partner to Regulatory and QA teams, facilitating seamless product registrations.
Conduct and lead project review meetings, strategy sessions with legal and R&D teams, and intra-departmental discussions on new initiatives.
Partner with Biopharmaceutics and BE centers to ensure the timely and successful completion of BEQ studies.
Develop and evolve efficient departmental systems to enhance productivity, cost/time management, and foster a culture of innovation and collaboration.
Forge strong partnerships across departments and manage vendor/supplier relationships to meet project needs.
Spearhead the sourcing of new equipment, vendor evaluations, and preparation of techno-commercial analyses and recommendations.
Collaborate closely with senior leadership on strategic initiatives for new formulation development.
Lead the integration of QbD principles during development and scale-up stages, ensuring robust and scalable processes.
Manage and optimize the product development budget and provide accurate forecasting.
Champion continuous professional / talent development through self-learning and training programs for the team.
Your experience and qualifications
Minimum year of Pharma R&D Experience - 15+ years. And 10+ years in the leadership role