Position Summary

The Drug Product Group Lead is responsible for the day-to-day leadership, technical oversight, and compliant execution of Drug Product (DP) manufacturing at Northway Biotech's Waltham site. The role oversees clinical fill-finish operations, process implementation, technology transfers, validation activities, and continuous improvement in accordance with cGMP, regulatory requirements, and customer expectations.

This is a hands-on technical leadership position within a small manufacturing team. In addition to coordinating and supervising DP activities, the DP Lead is expected to personally perform routine manufacturing operations within the production suite and actively participate in the execution of manufacturing processes.

The DP Lead works closely with Quality, MS&T, Engineering, Supply Chain, Program Management, and other functions to ensure manufacturing readiness and successful execution of client programs.

Key Responsibilities

• Lead and actively participate in day-to-day Drug Product manufacturing operations, including aseptic filling, formulation, final filtration, filling line operations, visual inspection, labeling, and packaging.

• Personally perform routine Drug Product manufacturing activities within the production suite, including equipment setup, operation, aseptic processing, filling operations, and associated manufacturing tasks.

• Provide direct supervision, technical guidance, and hands-on support to a small team of DP manufacturing personnel while remaining actively involved in daily production activities.

• Coordinate manufacturing priorities, staffing, resources, and readiness of processes, equipment, and documentation to support scheduled manufacturing campaigns.

• Provide hands-on technical leadership during manufacturing execution, equipment troubleshooting, deviation investigations, and resolution of operational issues.

• Lead and actively support customer Drug Product process implementation and technology transfers from development through clinical manufacturing, including engineering runs, PPQ, process validation, and continued process verification.

• Ensure compliance with cGMP, FDA, EMA, ICH, and internal quality systems; partner with Quality Assurance and maintain audit and inspection readiness.

• Prepare, review, and approve relevant SOPs, batch records, change controls, deviations, CAPAs, investigations, and validation documentation within delegated authority.

• Drive right-first-time performance, schedule adherence, operational KPIs, productivity, and continuous improvement initiatives.

• Train, coach, and develop Drug Product staff through direct technical instruction, hands-on demonstrations, and participation in manufacturing activities.

• Serve as the Drug Product technical point of contact for cross-functional teams and clients; support technical discussions, project scoping, and customer meetings as needed.

Qualifications & Requirements

• Bachelor's degree in Biotechnology, Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biology, or a related scientific discipline; advanced degree preferred.

• 8+ years of experience in biopharmaceutical manufacturing or pharmaceutical operations, including 3+ years in a leadership or supervisory role; CDMO experience strongly preferred.

• Demonstrated, extensive hands-on experience in clinical fill-finish manufacturing, aseptic processing, filling equipment operation, formulation, filtration, technology transfers, process validation, and troubleshooting.

• Proven ability and willingness to personally execute routine GMP manufacturing operations while simultaneously providing technical leadership and supervision to a small team.

• Recent practical experience working directly in GMP manufacturing environments, including cleanroom operations, manufacturing equipment setup, and execution of aseptic processes.

• Strong knowledge of GMP manufacturing, process validation and continued process verification, deviation and CAPA systems, and regulatory requirements for biologics manufacturing.

• Experience supporting regulatory and client inspections.

• Ability to work on-site at the Waltham, Massachusetts facility and regularly participate in manufacturing activities within the production suite.

Key Competencies

• Strong hands-on technical expertise in Drug Product manufacturing and aseptic fill-finish operations.

• Practical, execution-focused leadership approach with a willingness to work alongside manufacturing personnel.

• Ability to effectively lead a small team while independently executing technical and operational responsibilities.

• Strong troubleshooting skills and ability to resolve manufacturing and equipment-related issues directly.

• Ability to organize priorities, coordinate resources, and execute effectively in a dynamic manufacturing environment.

• Excellent communication, collaboration, coaching, and client-facing skills.

• Data-driven decision-making and continuous improvement mindset.

• Strong analytical, problem-solving, and risk-management capabilities.

• High integrity and strong commitment to quality, compliance, and operational excellence.