Senior Manager, Manufacturing Operations

Antares Pharma; Hopkins (MN); On-site; USD 180,000 - 230,000; Full time

Job summary

Antares Pharma in Minnetonka seeks a Senior Manager of Manufacturing Operations to lead multi‑shift cGMP assembly, labeling and packaging. You will translate site goals into capacity plans, staffing models, and execution roadmaps while enabling scalable clinical and commercial production.

You will drive performance through disciplined resource planning, risk‑based decision making, and cross‑functional governance with Quality, Engineering, Facilities, IT, and Supply Chain.

Qualifications

• Requires 8+ years in production environments within medical device or pharma with robotics/automation.
• 5+ years in people leadership for manufacturing lines and packaging.
• Experience scaling clinical-to-commercial production, tech transfer, and automation adoption.

Responsibilities

• Lead multi‑shift manufacturing operations for assembly, labeling, packaging, and related production.
• Develop manufacturing strategy, capacity models, staffing plans, and execution roadmaps.
• Drive performance using metrics on safety, quality, schedule adherence, and yield.
• Lead cross‑functional reviews and continuous improvement initiatives.
• Ensure compliance with cGMP and quality systems.
• Coach and develop manufacturing leaders and teams for succession readiness.

Skills

Leadership

Strategic planning

Lean Manufacturing

Six Sigma

Cross-functional collaboration

Executive communication

Risk-based decisions

Education

Bachelor's degree in Engineering

MBA or related master’s (preferred)

Tools

MES

ERP

Automation tools

Job description

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.

The Senior Manager translates site and business objectives into manufacturing strategy, capacity plans, operating priorities, and execution roadmaps. This individual drives strategic execution through effective resource planning, performance management, automation readiness, Manufacturing Execution System utilization, continuous improvement, and cross‑functional governance with Quality, Engineering, Facilities, Materials Management, Planning, IT, EHS, and other business partners. The role requires sound risk‑based decision‑making, executive‑ready communication, and the ability to lead transformational change while developing the next level of manufacturing leadership.

This individual operates in accordance with Halozyme policies and procedures, environmental, health, safety, and cGMP guidelines, and is expected to demonstrate readiness for broader site operations leadership as the organization continues to scale.

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.
• Other duties as assigned.

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.
• Ability 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

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.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

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.