Operations Manager Bioprocess

1 week ago

NC United States J&J Family of Companies Full time
Job Summary

We are seeking an experienced Bioprocess Operations Manager to join our team at Johnson & Johnson Innovative Medicine Supply Chain organization in Wilson, North Carolina. As a key member of our operations team, you will be responsible for leading the bioprocess operations, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.

Key Responsibilities
  • Manage all activities within the bioprocess operations function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
  • Ensure that all activities within the bioprocess operations function are planned and executed to meet business needs, customer needs, and the operations schedule.
  • Provide leadership and direction to colleagues within the bioprocess 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 bioprocess operations function.
  • Lead by example and strive to perform to high standards at all times in compliance with Credo and Leadership Behaviors.
  • Responsible and accountable for assuring the safe accomplishment of job activities in the bioprocess operations function and following good environmental practices and procedures.
  • Provide coaching and feedback to team and individuals to enable them to perform effectively.
  • Promote a culture of continuous improvement and open communication.
  • Recognize and respond to sources of change and manage change effectively.
  • 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.
  • Ensure that colleagues within the bioprocess 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 the bioprocess operations function.
Key Business Results
  • 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
Qualifications
  • 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
  • Experience in bioprocessing and managing audits
  • 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)
Preferred Qualifications
  • 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

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes - Within Country

Job Function Plant Management

Req ID: 2406205415W

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