Head of CMC; VP​/SVP Technical Operations

Head of CMC (VP/SVP) & Technical Operations (PR/610405) Maryland, USA

Salary: USD
300000 - USD
450000 per year

Head of CMC (VP/SVP) & Technical Operations

Location: Maryland

EPM Scientific is exclusively partnering with a clinical-stage biotech in the Maryland to identify aHead of CMC & Technical Operations during an important period of organizational and pipeline growth.

This individual will provide leadership across CMC and technical operations, with responsibility for building the capabilities, teams and infrastructure required to support programs from IND enabling, throughout clinical development, and into commercialization. The mandate is particularly well suited to an executive who enjoys operating in a growing biotech environment where strategy and hands-on execution are equally important.

• 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,BLAsubmission 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.

• 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> 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.