The Manufacturing Manager is responsible for the operational and strategic management of manufacturing activities including formulation, antibody conjugation, automated liquid handling-based workflows (e.g., Hamilton platforms), lyophilization, filling, and packaging in a regulated environment. This role ensures manufacturing operations are executed safely, compliantly, and efficiently while supporting both near-term production needs and long-term manufacturing readiness and scale, aligning with product demand and strategy defined by Operations leadership. In addition to overseeing daily manufacturing execution, the Manufacturing Manager leads manufacturing planning, capacity forecasting, and operational strategy, aligning manufacturing capabilities with product demand, technology roadmaps, and organizational growth. This role provides direct leadership to manufacturing staff, ensures personnel are trained and qualified for assigned tasks, and partners cross-functionally with Quality, Engineering, Supply Chain, and Product Development teams to support new product and process introduction, technology transfer, validation readiness, and sustained operations.

Responsibilities:

• Oversee daily manufacturing operations for reagent formulations, antibody conjugations, lyophilization, filling, and packaging.
• Ensure manufacturing documentation and records comply with GMP and ISO 13485 regulations.
• Ensure batch record review readiness and timely completion of manufacturing documentation.
• Develop and execute short- and mid-term manufacturing plans aligned with demand forecasts, capacity constraints, material availability, and quality requirements.
• Lead troubleshooting for manufacturing and equipment issues; escalate appropriately and coordinate cross-functional resolution.
• Establish and monitor manufacturing performance metrics (yield, throughput, utilization, deviations) and drive data-based decision-making.
• Forecast manufacturing capacity (equipment, staffing, consumables) and recommend actions to support growth and product roadmap needs.
• Drive process optimization to improve yield, cycle time, robustness, and quality.
• Partner with Operations leadership to support manufacturing strategy initiatives, including automation adoption, scale-up planning, and operational readiness.
• Partner cross-functionally with internal teams to support technology transfer, scale-up, and production launch.
• Lead Manufacturing participation in new product introduction (NPI) and new process introduction (PPI) to ensure manufacturing readiness from development through routine production.
• Identify training needs, ensure training plans are created and executed, and maintain qualification readiness per ISO 13485 requirements.
• Provide regular coaching, performance feedback, and development support for Manufacturing staff.
• Maintain manufacturing areas in an organized, controlled, and inspection-ready state; enforce safe work practices and compliance expectations.
• Support internal and external audits and regulatory inspections; maintain a continuous inspection-ready posture.
• Ensure execution of cycle counts and inventory controls; resolve discrepancies and implement preventative measures.

Required Qualifications:

• Bachelor's degree in biology, chemistry, biochemical engineering, or related field OR equivalent combination of education and progressive manufacturing leadership experience.
• 10+ years experience in regulated manufacturing (biotech, pharma, medical device, diagnostics), including 3+ years in a supervisory or management role.
• Demonstrated experience across formulation, filling/packaging/labeling, antibody conjugation, automated liquid handling platforms (e.g., Hamilton), and lyophilization
• Strong working knowledge of GMP and ISO 13485.
• Experience leading cross-functional initiatives supporting NPI/PPI or technology transfer.
• Proven leadership, problem-solving, and communication skills.

Preferred Qualifications:

• Hands-on familiarity with process characterization, scale-up, and validation readiness activities (e.g., support of IQ/OQ/PQ planning or execution).
• Practical experience driving or supporting continuous improvement initiatives within a manufacturing or operations organization.
• Experience implementing or supporting automation and digital manufacturing tools, including ERP, MES, or electronic batch record systems.
• Demonstrated ability to lead cross-functional teams by influence, aligning Manufacturing, Quality, Engineering, and Supply Chain toward shared objectives.

Physical Requirement:

• Ability to lift up to 25 lbs.
• Periodic presence on the manufacturing floor, including extended standing or walking as required.

The base salary range for this full-time position is $140,000 - $160,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.