Director- Formulation R&D

Brief team/department description:

R&D – Product Development

Delivery Captain Role: The “delivery captain” is a pivotal leadership role in end-to-end product development, responsible for steering a multidisciplinary team including formulation scientists, analytical scientists, and a project manager through every stage of the process. This leader coordinates closely with cross-functional teams such as clinical, regulatory, QA, and packaging, ensuring that each development stage receives the right expertise and input.

Relevance:
The delivery captain model is designed to maximize project success by integrating technical, regulatory, and commercial perspectives, ensuring seamless progression from concept to market. This approach not only accelerates development timelines but also strengthens accountability and cross-functional alignment, making the delivery captain critical to the organization’s innovation and growth strategy.

Roles & Responsibilities

• Assist product ideation and selection activities with a technical due diligence on feasibility within IP constraints, assessing timelines, patentability evaluations with IP department, making ballpark budgetary estimates, evaluating outsourcing verses in house developmental options, defining feasible TPP, clinical and regulatory pathways by consulting with respective internal or external stakeholders.
• Identify needs for outsourcing. To facilitate identification of right partner, provide all detailed scope of work / services / material requirements to alliance manager. Evaluate the various identified partners based on quality, time, cost, and prior experience and make recommendations.
• Support laying down various legal and commercial agreements with partners such as confidentiality disclosure agreement, master service agreement, pricing agreements, cost change orders etc.
• Evaluate and recommend need for consultation with external subject matter expert or a formal correspondence (Pre-IND, Pre-NDA, IND, Pre-ANDA, Controlled correspondences) with Agency to get clarity for focused efforts.
• Lay down milestone wise timelines for the allocated programs in consultation with cross functional teams. Identify and communicate various decision-making milestones during the lifecycle of a program.
• Drive timely execution and delivery of each program milestones. Effectively communicating with internal stakeholders, provide timely and accurate inputs or escalations on various aspects to minimize the slippage.
• Carry-out necessary internal reviews with ELT and CFTs to ensure that all key-stake holders are updated about the status of the program and possible delays with suggestions for readjustments and its impact on overall program timelines.
• Support annual budget preparation for allocated programs based on the estimates and understanding of various developmental, technology transfer, consultation, clinical etc costs.
• Monitor budgetary spends with the help of finance team. Provide timely estimates for unavoidable, unforeseen expenditures and take due approval for such spending by providing justifications.
• Monitor product development activities at the Azurity R&D centers. With the help of R&D team, ensure the activities are carried out in compliance with various quality, regulatory and EHS norms.
• Timely identify program needs such as equipment, instruments, manpower, facility modification and communicate recommendations to get necessary approvals from management.
• Identify need for various regulatory licenses required for R&D, clinical, and import activities. Timely providing inputs to the concerned department, follow up, escalate to ensure timely availability of such licenses.
• Actively monitor outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and decisions for successful task completions. Facilitate alignment on technical, quality and financial matters between the cross functional teams of respective companies.
• Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.
• Ensure the development is adequate, fulfilling recommended regulatory requirements provided by the respective departments to facilitate timely submission and minimizing deficiencies. Identify need for rationalization of regulatory needs and facilitate decision making by providing right inputs to CFT and management.
• Support the product launch team, sales and marketing team for any technical inputs / timely execution.
• Identify travel needs for project and get necessary approvals from superiors or management.
• Ensure compliance to quality and other policies / systems laid down by organization.
• Support creation or renewal and training of relevant SOP and guidelines for smooth functioning of the operations. Communicate any identified need for new clearer procedure or simplification of the existing procedures.

Qualifications and Experience Requirements

• Pharm or Ph.D in Pharmacy with minimum industrial experience of greater than 15 years in product development and scale-up of products.
• Preferred areas of expertise are Extended Release Oral Solid and Liquid Dosage forms, hands on experience in Bioavailability Enhancement techniques like Hot melt extrusion, SMEDDS and nanoparticulate drug delivery.
• Good understanding of PK/PD aspects of a dosage form.
• Candidate must have a minimum of 24 months experience in Azurity in his current role.