Sr. Manager, Manufacturing Operations

Core Responsibilities

• Manage 24/7, 365-day laboratory operations, ensuring consistent execution of automated and manual workflows.
• Own staffing, shift scheduling, utilization, and day-to-day operational performance of the laboratory.
• Ensure reliable service delivery, turnaround times, and adherence to operating standards.
• Provide direct supervisory oversight for laboratory operations teams across all shifts.
• Lead workforce planning, recruitment, onboarding, training, and ongoing development.
• Establish clear expectations, accountability, and communication rhythms through 1:1s, team meetings.
• Foster a culture of engagement, ownership, and continuous improvement in a 24/7 environment.
• Define, track, and enforce key performance indicators (KPIs) related to throughput, efficiency, turnaround time, and quality.
• Identify performance gaps, bottlenecks, and improvement opportunities; lead continuous improvement initiatives to optimize operations.
• Support implementation of scalable processes and best practices during periods of growth and change.
• Ensure adherence to cGMP, FDA, ICH, USP, EU, and other applicable regulatory standards.
• Promote a strong safety culture and proactively address risks that could impact employees or operations.
• Provide operational oversight of incoming and outgoing shipments of research supplies and client samples.
• Maintain inventory levels and coordinate ordering of laboratory supplies to support uninterrupted operations.
• Partner with other department leaders to support root cause analysis and investigations.
• Engage as needed in company-wide initiatives (e.g., internal task forces, special projects).

Required Qualifications

• Bachelor’s degree in Operations Management, Engineering or a related field.
• 5+ years of experience in Operations or Manufacturing Engineering roles in regulated industry.
• Experience in pharmaceutical, biotech, or similarly regulated laboratory or manufacturing environments.
• Strong working knowledge of cGMP, FDA, and ISO regulatory requirements.
• Proven ability to lead teams in fast-paced, high-growth, operationally complex environments.
• Strong data orientation with experience using KPIs to drive operational performance.

Preferred Experience

• Bachelor’s degree in Operations Management, Engineering or a related field.
• Master’s degree in Operations Management, Engineering or a related field.
• Experience leading operations teams in a startup environment.
• Exposure to common coding languages (Python, R, Mathematica, etc).
• Experience managing both Exempt and Non Exempt employees.
• Leverage Lean Certification and/or Six Sigma Greenbelt or Black Belt.