Shift Manager, Manufacturing Operations - Front End Nights - Biotech

About the role

The Shift Manager, Manufacturing Operations is responsible for leading safe, compliant, and efficient GMP manufacturing operations while developing a high-performing operations team. This role oversees daily GMP production activities for our night shift upstream and downstream drug substance manufacturing processes, drives operational excellence; and ensures alignment with business, quality, and regulatory objectives.

Responsibilities

• Lead, coach, and develop employees to build a high-performing, engaged, and inclusive team environment that supports operational excellence and continuous improvement
• Manage day-to-day personnel responsibilities including staffing, scheduling, performance management, employee relations, and consistent application of company policies, procedures, and leadership expectations
• Establish and manage clear goals, priorities, performance expectations, Individual Development Plans (IDPs), and learning plans aligned with business objectives
• Foster a culture aligned with the Novo Nordisk Way and NNWay essentials through employee engagement, recognition, collaboration, and support of organizational change initiatives across teams and functions
• Lead and oversee manufacturing and shift operations to ensure safe, compliant, and efficient execution of production activities while meeting business, quality, customer, and stakeholder objectives
• Establish, maintain, and continuously improve operational processes through standardization, simplification, problem solving, and sustainable process improvements across teams and shifts
• Align operational activities with production lead-time targets, site priorities, and performance expectations to support operational continuity and business objectives
• Support the implementation, validation, maintenance, and continuous improvement of manufacturing systems, equipment, and processes as required
• Lead and collaborate on cross-functional operational initiatives, improvement projects, audits, inspections, and regulatory interactions to ensure operational readiness and compliance
• Supports manufacturing activities in other departments as instructed by manager

Requirements

• Bachelor’s degree from an accredited university with a minimum of three (3) years of experience in a manufacturing organization required, preferably pharmaceutical manufacturing
• May consider an Associate’s degree from an accredited university with a minimum of five (5) years of experience in a manufacturing environment, required, preferably pharmaceutical manufacturing
• May consider a High School diploma or GED with seven (7) years of experience in a manufacturing environment, required, preferably pharmaceutical manufacturing
• Minimum of three (3) years of direct supervisory experience required or for internal candidates may consider successful completion of NN leadership talent development program (ie: GROW or other combination of training and experience)
• Comprehensive knowledge of pharmaceutical manufacturing operations and production processes within a regulated cGMP environment required
• Strong communication, interpersonal, and influencing skills with the ability to collaborate effectively across all organizational levels and functions required
• Ability to maintain compliance with cGMP requirements, company policies, regulatory expectations, and ethical business standards while ensuring inspection readiness required
• Computer expertise in the following applications: MS Word, Outlook, Excel, PowerPoint and Access, PLCs, PAS-X and SAP a plus
• Ability to read, write and understand complicated product documentation and standard operating procedures with attention to detail required
• Proven ability to drive continuous improvement through process optimization, data-driven problem-solving, organizational change leadership, and application of Lean and Six Sigma methodologies
• Skilled in fostering a culture of quality, compliance, safety, and operational excellence preferred
• Ability to lead and develop employees through coaching, performance management, feedback, recognition, and career development planning required
• Proven ability to effectively manage change, promote employee engagement, and support a positive and inclusive work environment
• Knowledge of environmental, health, safety, and compliance requirements and their application in manufacturing operations

Qualifications

• Bachelor’s degree from an accredited university with a minimum of three (3) years of experience in a manufacturing organization required, preferably pharmaceutical manufacturing
• May consider an Associate’s degree from an accredited university with a minimum of five (5) years of experience in a manufacturing environment, required, preferably pharmaceutical manufacturing
• May consider a High School diploma or GED with seven (7) years of experience in a manufacturing environment, required, preferably pharmaceutical manufacturing
• Minimum of three (3) years of direct supervisory experience required or for internal candidates may consider successful completion of NN leadership talent development program (ie: GROW or other combination of training and experience)
• Comprehensive knowledge of pharmaceutical manufacturing operations and production processes within a regulated cGMP environment required
• Strong communication, interpersonal, and influencing skills with the ability to collaborate effectively across all organizational levels and functions required
• Ability to maintain compliance with cGMP requirements, company policies, regulatory expectations, and ethical business standards while ensuring inspection readiness required
• Computer expertise in the following applications: MS Word, Outlook, Excel, PowerPoint and Access, PLCs, PAS-X and SAP a plus
• Ability to read, write and understand complicated product documentation and standard operating procedures with attention to detail required
• Proven ability to drive continuous improvement through process optimization, data-driven problem-solving, organizational change leadership, and application of Lean and Six Sigma methodologies
• Skilled in fostering a culture of quality, compliance, safety, and operational excellence preferred
• Ability to lead and develop employees through coaching, performance management, feedback, recognition, and career development planning required
• Proven ability to effectively manage change, promote employee engagement, and support a positive and inclusive work environment
• Knowledge of environmental, health, safety, and compliance requirements and their application in manufacturing operations