Senior Director, Synthetics Late-Stage Analytical Development

As the Senior Director and Lead of the Late-Stage Analytical Development teams in Mumbai, you will have a unique opportunity to drive excellence and innovation in method development and stability activities for our Synthetic R&D products. With a team comprising around 65 highly skilled analytical scientists and bolstered by the capabilities of an External Contract Lab (ECL) based in Mumbai, you will have the resources and talent necessary to achieve exceptional results.

Furthermore, you will play a crucial role as the primary Synthetics Indian based senior leader in supporting the global organization's efforts to expand R&D activities beyond Late-Stage Analytical Development.

In addition to leading the analytical development efforts, you will serve as the Site Lead for Mumbai, ensuring seamless operational functionality of the JJIM Mumbai facilities.

Responsibilities:

Lead the late-stage method development and stability teams based in Mumbai, ensuring efficient and high-quality analytical support for synthetic products throughout their lifecycle. Drive the development and validation of analytical methods for late-stage programs, facilitating the efficient transfer of methods to commercial manufacturing sites. Lead troubleshooting efforts for method-related issues, providing technical expertise and driving the resolution of challenges. Oversee stability studies and ensure compliance with regulatory requirements, guiding the team in the implementation of stability protocols and the execution of stability testing.

Act as the primary point of contact for cross-functional collaboration with global teams, providing technical expertise and guidance as necessary.

Develop and execute strategic plans to optimize resource allocation and utilization across teams, fostering a culture of innovation, collaboration, and continuous improvement.

Build and nurture an external network of Contract Development and Manufacturing Organizations (CDMOs) in India, specifically in API (Active Pharmaceutical Ingredient), DP (Drug Product), and AD (Analytical Development) areas.

Collaborate with internal stakeholders, including manufacturing, regulatory, and quality teams, to align on project goals, timelines, and deliverables. Collaborate with cross-functional teams, including Analytical Development, Quality Control, and Regulatory Affairs, to ensure alignment and seamless integration of activities.

Drive the implementation of industry best practices and regulatory standards in late stage method development and stability studies, ensuring compliance and adherence to relevant guidelines.

Foster a culture of talent development, providing mentorship, support, and guidance to the team members, fostering their professional growth and ensuring a high-performance work environment.

Stay updated with the latest advancements in analytical technologies, industry trends, and regulatory requirements, and drive their incorporation within the teams and projects.

Site Lead for Mumbai ensuring seamless operational functionality of the JJIM Mumbai facilities.

A Ph.D. in Analytical Chemistry or a related field with a minimum of 12 years of relevant experience, preferably in the pharmaceutical industry.

Strong technical expertise in late-stage method development and stability studies for synthetic products, with a track record of successful project execution. Solid understanding of regulatory guidelines and requirements (e.g., ICH, FDA, EMA) pertaining to method development and stability studies.

Demonstrated leadership experience, including managing cross-functional teams and optimizing resources across multiple projects.

Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively with stakeholders at various levels within the organization. - Proven ability to build and maintain relationships with external partners and CDMOs.

In-depth knowledge of regulatory requirements and industry guidelines related to late-stage analytical development.

Strong problem-solving skills, adaptability, and the ability to drive change in a complex and fast-paced environment.

Travel: