Johnson & Johnson is currently seeking Operations Manager Bioprocess to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

• Manage all activities within the Operations function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Ensure that all activities within the Operations function are planned and executed to meet business needs, customer needs and the Operations schedule.
• Responsibility for managing resources within the Operations function.
• Providing leadership and direction to colleagues within the Operations function.
• Promote a culture of continuous improvement and open communication.
• Ensure that personnel are recruited and trained to support activities in line with business needs and site recruitment plan.
• Support Commissioning, Qualification, Validation and Technical Support activities related to the Operations function.
• Lead by example and strive to perform to high standards at all times in compliance with Credo and Leadership Behaviors. Act as a role model for all colleagues within the Operations department.
• Responsible and accountable for assuring the safe accomplishment of job activities in the Operations function and following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
• Providing leadership and direction to colleagues within the Operations function to ensure that goals, targets and expectations are communicated clearly.
• Respond to all concerns/issues raised by colleagues in an appropriate and timely manner.
• Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
• Monitor Operations, quality and EHS metrics/KPIs to ensure that departmental goals and targets are met.
• Provide coaching and feedback to team and individuals to enable them to perform effectively.
• Promote a culture of continuous improvement and open communication. Listen to, and involve colleagues in departmental decisions, goal setting etc. Seek feedback from colleagues to ensure that needs are being met and to ensure proper focus of resources.
• Recognize and respond to sources of change and manage change effectively. Promote a culture where change is viewed with a positive outlook.
• Completion of assigned tasks/projects/activities to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
• Directly responsible person during internal and external audits (e.g. Compliance audit, Internal audit) and able to articulate and walk auditors through all processes in detail.
• Ensuring that colleagues within the Operations function are provided with appropriate training to perform their assigned duties to meet the business needs and regulatory requirements.
• Pursue opportunities to develop colleagues within Operations function.

• Customer Service Levels / OTS / OTD / OTIF / LIFR
• Inventory KPIs
• Quality - Critical Observations / Field Escalations / CAPA Closure
• Cost Improvement plans
• EHS&S - Good Saves, Significant Good Saves, Lost Working Days

• B.S. degree in engineering, science or an IT discipline
• A minimum of 6 years of relevant experience in a manufacturing GMP environment, biopharmaceutical or pharmaceutical industry Extensive people management and leadership experience, including developing colleagues within operations.
• Strong interpersonal skills to build productive relationships, collaborate effectively, and work well within a team while treating others with dignity and respect.
• Flexibility and adaptability in a dynamic supply chain environment, with the ability to act quickly and with accountability to meet organizational goals.
• Cultural sensitivity and ability to thrive in a multi-cultural and matrixed environment.
• Strong enterprise awareness, enabling informed decisions that align with organizational priorities.
• Customer-focused and results-driven, with a clear understanding of how your work impacts the enterprise, leading to effective decision-making and prioritization
• Extensive GMP compliance experience in pharmaceutical manufacturing.
• Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals.
• Maintain high ethical standards and integrity through Credo-based actions.
• Facilitate continuous improvement and innovation, challenging the status quo to drive positive change.
• Work as a strategic partner with all departments across the company.
• Hold yourself accountable for compliant and flawless execution.
• Advanced proficiency in English (speaking, reading, and writing).

• Experience in bioprocessing and managing audits
• Experience of Media & Buffer preparation in an Operations environment.
• Experience of Microsoft Word Excel and Outlook.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.
• Experience of SAP or other business systems.
• Experience in Cleaning and Sterilization
• Experience of Autoclaves and Sterilization.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year