Manufacturing Manager, Drug Substance

Position Overview

The Manufacturing Manager, Drug Substance will lead and manage all aspects of upstream and downstream manufacturing operations. This role is critical for ensuring the compliant, safe, and efficient production of biologics drug substance. You will be responsible for leading a team of manufacturing associates, driving operational excellence and fostering a strong culture of quality and continuous improvement within a GMP environment. Your leadership will be key to the successful technology transfer and scale-up of client processes.

Key Responsibilities

• Leadership & Team Management: Lead, mentor, coach and develop a high-performing manufacturing team. Set clear performance expectations, foster a culture of accountability, and ensure a safe and engaged working environment.

• Manufacturing Operations: Oversee day-to-day drug substance manufacturing (upstream and/or downstream) including cell culture, centrifugation, chromatography, TFF, and depth filtration. Ensure production schedules are met while adhering to the highest quality and safety standards.

• GMP & Compliance: Ensure strict adherence to cGMP, FDA, and other regulatory requirements. Oversee cGMP documentation, batch record compliance, and be inspection-ready at all times.

• Process Improvement & Tech Transfer: Drive continuous improvement initiatives (Lean/Six Sigma) to optimize processes, increase throughput, reduce costs and enhance process robustness. Partner with cross-functional teams (MSAT, Quality, Engineering) to support successful technology transfer and new product introduction.

• Quality & Investigations: Lead or support deviation investigations, root cause analyses, and the implementation of effective CAPAs to resolve operational issues and prevent recurrence.

• Strategic Planning: Own departmental operations including budget, capacity planning, resource allocation, and staffing strategies to meet business objectives.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related technical field required. Master's degree preferred.

• Experience: A minimum of 5-8+ years of progressive experience in a cGMP manufacturing environment within the pharmaceutical or biopharmaceutical industry. Proven experience in biologics drug substance manufacturing, specifically in upstream cell culture or downstream purification processes. At least 3+ years of experience directly managing people and leading teams. Experience in a CDMO environment is highly preferred. Experience with facility start-up, operational readiness, or capital projects is a significant advantage.

Skills

• In-depth knowledge of GMP regulations, quality systems (change control, deviations, CAPAs) and FDA regulatory requirements.

• Strong leadership, teambuilding, and coaching skills.

• Excellent problem-solving, analytical, and decision-making abilities.

• Strong written and verbal communication skills, with the ability to collaborate effectively across all levels of the organization.