Director CMC Project Management

Job Title: Director, CMC Project Management

Location: Hyderabad, India

Client: US based biotech

About the Company:

My client are a well-funded, rapidly growing US based biotech company dedicated to discovering and developing innovative biologics in Oncology and Immunology. Their mission is to transform cutting-edge science into breakthrough therapies that address critical unmet medical needs. With a team of experienced professionals, they are expanding our operations to support the next wave of programs through regulatory submission and clinical development.

Position Overview:

My client is seeking a highly motivated and results-driven Director, CMC Project Management to lead and coordinate CMC activities at a Contract Development and Manufacturing Organization (CDMO) in Hyderabad, India. The role may also involve oversight of additional sites within the country. The ideal candidate will possess deep expertise in drug development at CDMOs, a strategic mindset, and the ability to drive complex projects in a fast-paced biotech environment. This role requires exceptional leadership, organizational, and communication skills to oversee CMC operations from early to late-phase clinical development at CDMOs.

Key Responsibilities:

• Develop and manage comprehensive CMC project plans, ensuring alignment with corporate objectives and program milestones.
• Lead high-impact CMC projects at CDMO sites, ensuring timely execution and adherence to strategic goals.
• Oversee project delivery, focusing on milestone achievement, risk mitigation, and scope management.
• Implement advanced project management methodologies to enhance project efficiency.
• Manage multiple projects simultaneously, ensuring they are delivered on time and within budget.
• Identify risks and proactively develop mitigation and contingency plans.
• Facilitate regular team meetings, including agenda setting, action tracking, and follow-ups.
• Ensure financial accountability by managing budgets and change controls effectively.
• Prepare reports, dashboards, and presentations to communicate project status, key metrics, and risk mitigation strategies.
• Foster cross-functional collaboration to align CMC activities with overall project goals.
• Provide project updates to stakeholders, ensuring transparency in decision-making.
• Coordinate the preparation and submission of regulatory filings as required.

Qualifications:

• Advanced degree in science, engineering, or a health-related field.
• PMP or equivalent project management certification preferred.
• Minimum 10+ years of experience in CMC operations within the biotech or pharmaceutical industry, with at least 5+ years in project management leadership roles.
• Strong understanding of the drug development process, including CMC, clinical, and regulatory filing activities.
• Proven experience using project management tools and methodologies for CMC activities.
• Experience managing contract manufacturing/testing organization (CMO/CTO) relationships and projects.
• Strong attention to detail, time management, and organizational skills.
• Ability to learn quickly and adapt to a fast-paced, evolving environment.
• Demonstrated ability to lead cross-functional teams and foster a collaborative culture.
• Proven track record of driving projects to completion while maintaining a positive and transparent team environment.
• Strong leadership and interpersonal skills with the ability to interact and influence across functions.
• Ability to manage multiple priorities in a dynamic, virtual, and small biotech environment.
• Proficiency in MS Office (Excel, PowerPoint, Word) with strong presentation and data visualization skills.
• Logical, analytical, and strategic thinking capabilities.
• Remote position with travel required as needed.

What They Offer:

• A chance to make a significant impact in developing innovative therapies in Oncology and Immunology.
• A collaborative and innovative work environment with passionate professionals.
• Competitive compensation, including equity options.
• Comprehensive benefits package.
• Professional growth and development opportunities within a rapidly growing company.

How to Apply

Interested candidates should submit their resume and a cover letter outlining their relevant experience.