Senior Director of Manufacturing

Senior Director of Manufacturing 
Location: Maryland

About Our Client:
Our client is a leading biotech company at the forefront of innovation, focused on developing cutting-edge therapies that address unmet medical needs. With a diverse pipeline of small molecule and gene therapy projects, they are committed to advancing healthcare through scientific excellence and collaboration.

Position Overview:
We are recruiting a Senior Director of Manufacturing to lead and direct all aspects of Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical drugs and agents. In this critical role, you will oversee the manufacturing processes and analytical work associated with CMC across all small molecule projects and potentially gene therapy initiatives. This leadership position is key to ensuring successful product development and regulatory compliance as our client continues to advance its drug pipeline.

Key Responsibilities:

• Oversee all CMC activities for small molecule pharmaceutical projects, including the development, manufacturing, and regulatory compliance of drug substances and products.
• Provide strategic direction and leadership for manufacturing operations, ensuring alignment with company goals and project timelines.
• Manage analytical development, including method development, validation, and stability studies, to support CMC activities.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) for manufacturing and quality standards across all projects.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and external partners, to drive project success.
• Lead and mentor a team of scientists and engineers, fostering a culture of innovation, accountability, and operational excellence.
• Develop and manage CMC budgets, timelines, and resource allocation to optimize project delivery.
• Stay current with industry trends and technological advancements in CMC, applying best practices to manufacturing operations.

Qualifications:

• PhD in Chemistry, Biochemistry, Chemical Engineering, or a related field.
• 10+ years of experience in CMC roles, with a strong background in pharmaceutical manufacturing, especially in small molecule drugs.
• Expertise in CMC regulatory requirements (FDA, EMA) and experience managing interactions with regulatory agencies.
• Proven leadership experience in directing manufacturing and analytical teams in a biotech or pharmaceutical environment.
• Strong problem-solving skills and ability to work in a fast-paced, dynamic environment.
• Excellent communication and collaboration skills, with the ability to manage cross-functional teams and external partners.

Why Apply?
This is a unique opportunity to play a pivotal role in the development and commercialization of life-saving therapies. If you are a driven leader with deep expertise in CMC and a passion for innovation, this role offers the chance to make a meaningful impact in a leading biotech company.