Senior Vice President- Business Development CMC

About the Company:

Great opportunity to lead the CMC function, steering both product and business development efforts. The position will oversee CMC's strategy and execution to ensure successful product development through its full cycle and compliance with regulatory requirements and industry standards. Must have experience leading a team and head of CMC. Must have experience experience driving client engagement and business development through long-term relationship building.

About the Role:

• Lead, develop, and mentor the team members, while driving efforts that support the company vision and mission

• Develop long-term client relationships by understanding their needs, personalizing services, maintaining transparent communication, and consistently exceeding expectations.

• Formulate strategies for diverse business modules like standalone, integrated, market-specific, and client insight analysis.

• Spearhead the design of BioDev's comprehensive integrated technical capability portfolio.

• Formulate, lead, and articulate CMC strategies tailored to each phase, aligning with corporate goals and regulatory mandates, encompassing product characterization, process development, validation, and clinical and commercial supply.

Set guidelines, oversee the selection, and manage CDMOs to ensure the efficient and cost-effective execution of development and manufacturing projects, including negotiating contracts, project management, and evaluating performance.

Oversee the enhancement and scaling of GMP manufacturing processes to meet clinical and commercial supply requirements, ensuring product quality and regulatory standards adherence.

• Partner closely with senior leadership and cross-functional teams to integrate CMC considerations into comprehensive product development plans, ensuring alignment and proactively identifying risks with corresponding mitigation strategies.

• Champion efforts to enhance excellence and streamline the progression of projects through CMC development stages.

• Remain updated on emerging trends, technologies, and best practices in CMC development to guide informed decision-making and strategy implementation.

• Serve as the company's liaison with regulatory agencies, offering CMC expertise and support for regulatory submissions, inspections, and responding to inquiries.

Qualifications:

• Degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Sciences, or related discipline
• Experienced in successfully leading and managing business development teams to drive growth and achieve strategic objectives.
• In-depth understanding of regulatory standards and guidelines that govern CMC activities within pharmaceutical product development.
• Extensive technical proficiency in CMC development and manufacturing, essential for advancing clinical programs and achieving commercialization goals.
• Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, senior leadership, and external partners
• Proven track record of strategic thinking, solving complex challenges, and delivering results in a dynamic and fast-moving environment.