Senior Manager, Manufacturing Operations

Position Summary

The Senior Manager, Manufacturing Operations leads the Manufacturing Operations function at the Minnetonka facility and is accountable for safe, compliant, and efficient cGMP assembly, labeling, packaging, and related production activities for combination pharmaceutical products. This role provides leadership across multi-shift operations while building the systems, processes, talent, and capabilities required to scale clinical and commercial production in support of long-term business growth.

Essential Functions And Responsibilities

• Lead safe, compliant, and efficient multi-shift manufacturing operations for cGMP assembly, labeling, packaging, and related production activities supporting clinical and commercial product supply.
• Translate site and business objectives into manufacturing strategy, staffing plans, capacity models, operating priorities, and execution roadmaps that support operational scale-up and long-term growth.
• Drive manufacturing performance through disciplined resource planning, escalation practices, risk-based decision-making, and metrics including safety, quality, schedule adherence, throughput, utilization, productivity, yield, and right-first-time performance.
• Lead monthly cross functional meetings to review and improve performance.
• Lead continuous improvement and operational excellence practices that improve stability, reliability, and scalability.
• Execute Strategic Initiatives.
• Ensure Manufacturing Operations complies with cGMP regulations and the current quality management system.
• Build, coach, mentor, and develop manufacturing leaders and team members while strengthening technical capability, supervisory effectiveness, training programs, qualification expectations, procedural compliance, operational ownership, and succession readiness.
• Provide executive-ready communication, operational updates, business case input, and escalation support related to manufacturing performance, capacity, risks, constraints, and improvement priorities.
• Foster cross-functional governance and collaboration with Quality, Engineering, Facilities, Materials Management, Planning, IT, EHS, HR, Supply Chain, and external partners to ensure aligned execution of manufacturing priorities.
• Operate and monitor manufacturing equipment, as needed, to support clinical and commercial pharmaceutical product production.

Education, Experience, Knowledge, Skills And Abilities

• Bachelor’s degree in Engineering, Science, Operations, Supply Chain, Business, or related technical discipline required; Science or Engineering degree preferred.
• Advanced degree in Business, Operations, Engineering, or related leadership discipline preferred; equivalent progressive operations leadership experience may be considered.
• 8+ years of experience working in a production environment in the medical device or pharmaceutical industry which incorporated robotics/automation within their processes.
• 5+ years of experience managing a team working on manufacturing lines for the production and packaging of Medical Device and/or pharmaceutical products.
• Demonstrated ability to translate business and site objectives into manufacturing strategies, capacity plans, staffing models, execution roadmaps, and measurable operational outcomes.
• Experience supporting clinical-to-commercial scale-up, production expansion, new product introduction, technology transfer, automation implementation, Manufacturing Execution Systems, electronic batch records, ERP or production planning systems, digital workflows, and data-driven performance management preferred.
• Strong knowledge of cGMP, quality systems, ISO standards, regulatory expectations, audit readiness, deviation management, CAPA, change control, validation, inspection support, and related documentation requirements.
• Operational excellence mindset with experience applying Lean Manufacturing, Six Sigma, 5S, standard work, visual management, root cause analysis, and continuous improvement methods to improve manufacturing performance.
• Proven ability to lead transformational change, manage competing priorities, make risk-based decisions, resolve operational constraints, and deliver results in a fast-paced, high-growth manufacturing environment while keeping team members engaged throughout the process.
• Strong people leadership skills with demonstrated ability to coach, mentor, develop, and hold leaders and team members accountable while building organizational capability and succession readiness.
• Able to build effective cross-functional relationships and governance routines with Quality, Engineering, Facilities, Planning, Materials Management, IT, EHS, HR, Supply Chain, and external partners.
• Excellent written, verbal, and executive-level communication skills with demonstrated leadership maturity, strategic thinking, ownership, learning agility, and readiness for broader site operations leadership responsibilities.

Environmental Conditions

• Physical Activities: This role requires a combination of office-based work and regular presence in manufacturing areas. On a continuous basis, the employee may be seated at a desk, use a computer, answer the telephone, attend meetings, and review documentation. The role may also require walking through production areas, standing for periods of time, entering controlled manufacturing environments, following applicable gowning or safety requirements, and occasionally lifting up to 30 lbs.
• The noise level in the work environment is typically low to moderate but may vary in manufacturing areas.

Manufacturing and Controlled Environment Activities, if applicable

• Work may require entry into manufacturing, packaging, warehouse, laboratory, or controlled environments.
• The employee must follow applicable environmental, health, safety, gowning, hygiene, and cGMP requirements.

Travel

• Travel may be required up to 5% of your time.