Senior Manager, Bioprocess Manufacturing Operations

EPM Scientific is partnered with a leading CDMO organization undergoing significant expansion across its biologics manufacturing network. As part of a strategic investment in plasmid DNA production capabilities, the organization is building out a highly visible manufacturing program that will play a critical role in supporting future client demand, technology transfers, and commercial-scale operations.

This opportunity offers the chance to join a growing leadership team and take ownership of a newly expanding manufacturing platform. The ideal candidate will combine strong GMP manufacturing expertise with the ability to build teams, develop operational strategy, and drive execution in a fast-paced CDMO environment. This role is highly visible within the organization and offers long-term career growth potential into broader operational leadership positions.

Responsibilities

• Lead day-to-day GMP manufacturing operations supporting biologics production activities across fermentation, harvest, purification, filtration, buffer preparation, and related manufacturing processes.
• Provide leadership and oversight for a growing team of supervisors, group leaders, and manufacturing associates.
• Drive successful execution of technology transfers, engineering runs, process scale-up activities, and manufacturing readiness initiatives.
• Partner closely with MS&T, Quality, Supply Chain, Validation, Engineering, and Project Management teams to achieve production objectives.
• Develop and implement strategies to improve throughput, schedule adherence, right-first-time execution, and overall manufacturing performance.
• Lead investigations, root-cause analyses, deviation management, and CAPA activities to ensure sustainable operational excellence.
• Establish a culture centered around safety, quality, accountability, and continuous improvement.
• Support client-facing activities including audits, inspections, technical discussions, and operational reviews.
• Monitor operational KPIs and utilize data-driven decision-making to identify opportunities for efficiency and process improvement.
• Serve as a key leadership representative for the manufacturing organization, helping shape long-term program strategy and organizational growth.

Qualifications

• 8+ years of experience within GMP biologics, biotechnology, vaccine, microbial fermentation, or related manufacturing environments.
• Prior leadership experience overseeing manufacturing teams, supervisors, and cross-functional operations within a regulated environment.
• Strong understanding of upstream manufacturing processes, including microbial fermentation and associated production operations.
• Experience supporting technology transfer, process scale-up, engineering runs, or commercial manufacturing readiness programs.
• Demonstrated success leading operational improvements, troubleshooting manufacturing challenges, and driving performance through metrics.
• Experience working within a CDMO environment is strongly preferred.
• Strong business acumen with the ability to operate both strategically and tactically across complex manufacturing organizations.
• Excellent communication and stakeholder management skills with the ability to influence teams across multiple functions.
• Proven ability to build, develop, and mentor high-performing teams in a fast-paced growth environment.
• Bachelor's degree required; advanced scientific, engineering, or biotechnology degree preferred.