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. The position partners cross-functionally to improve processes, standardize operations, and support continuous improvement initiatives across the manufacturing organization.

Essential Functions

• 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
• Provide ongoing coaching, feedback, training, and development opportunities to support employee growth, technical capability, accountability, and succession planning
• 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
• Promote and maintain a strong culture of safety, environmental stewardship, compliance, and operational excellence in alignment with cGMPs, quality standards, regulatory requirements, and Novo Nordisk values
• 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
• Support the implementation, validation, maintenance, and continuous improvement of manufacturing systems, equipment, and processes as required
• Working in the cleanroom areas may require wearing: hairnet, beard cover, frocks/coveralls, shoe covers, snood, face mask, sterile gloves, and to follow GMP processes at all times. Examples of prohibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelry, cosmetics, nail acrylics, perfume/cologne, and personal cell phones

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
• Ability to identify operational risks, evaluate complex situations, and make sound decisions in a fast-paced manufacturing environment preferred
• 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
• 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