VP, CMC & Technical Operations - Growth Leader

EO; Maryland; On-site; USD 300,000 - 450,000; Full time

Job summary

EPM Scientific is partnering with a Maryland biopharmaceutical company to identify a Head of CMC and Technical Operations. This executive will lead the CMC strategy and ensure alignment with clinical and business goals through IND enabling, clinical development and commercialization.

The role requires building capabilities, leading multidisciplinary teams, and driving regulatory interactions with health authorities, including the FDA, to advance complex biologic programs toward BLA approval and

Qualifications

• Ph.D. or equivalent advanced degree in a relevant scientific or engineering discipline.
• Approximately 20+ years of experience across biopharmaceutical development, CMC, manufacturing and/or technical operations, with progressive leadership responsibility.
• Significant experience leading CMC activities for complex biologic products or technically demanding manufacturing platforms within a biotechnology or biopharmaceutical environment is preferred (C&GT is a plus).
• Broad technical understanding across areas such as process development, manufacturing, analytical development, quality control and supply chain.
• Demonstrated ability to lead multidisciplinary technical teams while remaining sufficiently close to the work to address critical scientific, manufacturing and operational challenges.
• Experience developing CMC strategies appropriate to different phases of clinical development and adapting technical capabilities as programs mature.
• Meaningful experience with regulatory submissions and direct interactions with the FDA and/or other global health authorities.
• Experience advancing programs from IND-enabling development through BLA approval and successful commercial launch is highly preferred.

Responsibilities

• Establish and lead the organization’s overall CMC strategy, ensuring development timelines remain aligned with broader clinical and business objectives.
• Provide leadership across key technical functions, including process development, analytical sciences, quality control, & supply chain.
• Guide CMC activities across the development lifecycle, from IND-enabling through pivotal clinical development, BLA submission and commercialization.
• Assess existing technical capabilities and identify opportunities to strengthen processes, infrastructure, systems and organizational capabilities as programs advance.
• Maintain active involvement in complex technical and operational challenges, providing both executive leadership and hands‑on problem solving when required.
• Ensure CMC activities are conducted within appropriate quality and cGMP frameworks and evolve appropriately as programs progress.
• Provide senior CMC leadership for regulatory strategy, submissions and interactions with health authorities.
• Recruit, develop and mentor technical leaders while creating a collaborative, high-performing CMC organization.
• Partner closely with executive leadership and cross-functional stakeholders to establish priorities, allocate resources and prepare the organization for continued growth.

Skills

CMC leadership

Regulatory submissions

Biopharmaceutical development

Process development

Analytical development

Quality control

Supply chain

Strategic leadership

FDA interactions

Education

Ph.D. or equivalent

Job description

EPM Scientific is partnering with a Maryland biopharmaceutical company to identify a Head of CMC and Technical Operations. This executive will lead the CMC strategy and ensure alignment with clinical and business goals through IND enabling, clinical development and commercialization.

The role requires building capabilities, leading multidisciplinary teams, and driving regulatory interactions with health authorities, including the FDA, to advance complex biologic programs toward BLA approval and