Business Unit Manager - Cell Culture-1420990W
Description
Position Title: Business Unit Manager – Cell Culture
Department: Operations
Location: JBIL - Ringaskiddy
Travel: As required
Global Compensation Framework Band Number: 31
Company Summary: (As per standard for other Janssen Biologics ad’s)
Position Summary:
This position is responsible for managing the Cell Culture function within the Operations department. This includes but is not limited to:
• Manage all activities within the Cell Culture function in compliance with corporate,
cGMP, EHS, and other regulatory requirements.
• Ensure that activities within the Cell Culture area are planned and executed to meet
business needs and Operations schedule.
• Responsibility for managing resources within Cell Culture unit operations of Pre-Culture,
Cell Culture, Media Preparation, Equipment Preparation and Weigh & Dispense.
• Providing leadership and direction to colleagues within the Cell Culture 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, PDMS and GTS activities related to Cell
Culture operations.
Main duties and responsibilities:
• Lead by example and strive to perform to high standards at all times in compliance with Credo and Standards of Leadership. Act as a role model for all colleagues within the Operations Department.
• Responsible and accountable for assuring the safe accomplishment of job activities in Operations Cell Culture and following good environmental practices and procedures
• Manage all activities within the Cell Culture function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Ensure that all activities within the Cell Culture function are planned and executed to meet business needs, customer needs and Operations schedule.
• Responsibility for managing resources within Cell Culture unit operations of Pre-Culture,
Cell Culture, Media Preparation, Equipment Preparation and Weigh & Dispense.
• Providing leadership and direction to colleagues within the Cell Culture function to ensure that goals, targets and expectations are communicated clearly.
• Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
• 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 colleague in departmental decisions, goal setting etc. Seek feedback from colleagues to ensure that needs are being met and to ensure proper focus of resources.
• Support to Commissioning, Qualification, Validation, PDMS & GTS activities.
• Pursue opportunities to develop colleagues within Cell Culture and other Operations functions.
• Ensure that housekeeping standards in Cell Culture areas and other areas within the Operations facility are maintained to a very high standard of GMP readiness.
• Manage resources of the Cell Culture function within budgetary constraints.
• Deputize to Cell Culture Team Leads and Team Co-ordinator as appropriate.
• Delegate responsibility and empower reports where appropriate to ensure personal effectiveness.
• Deputize for Purification Manager, Technical Operations Manager and Director of Operations as appropriate
• Ensure visibility in the Cell Culture Operations area through regular walkthrough of the area.
• Travel to JSC, J&J and other external sites as required for meetings, training etc.
Key Skills and Competencies required:
• Leadership and development of all colleagues within the Business Unit
• Customer focused and results driven
• Collaboration and teamwork across site functions and other JSC / J&J sites
• Demonstrate Integrity and Credo-based actions at all times
• Work as a strategic partner with all other departments within the company and to align across other JSC / J&J sites
Qualifications
Education and Experience:
ESSENTIAL
• Third level qualification in science or engineering discipline.
• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
• Experience in supervison/management of people and resources.
DESIRABLE
• Operations experience within a Life Sciences or Biopharmaceutical Environment
• Experience of Cell Culture / Fermentation in an Operations environment.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Production
Description
Position Title: Business Unit Manager – Cell Culture
Department: Operations
Location: JBIL - Ringaskiddy
Travel: As required
Global Compensation Framework Band Number: 31
Company Summary: (As per standard for other Janssen Biologics ad’s)
Position Summary:
This position is responsible for managing the Cell Culture function within the Operations department. This includes but is not limited to:
• Manage all activities within the Cell Culture function in compliance with corporate,
cGMP, EHS, and other regulatory requirements.
• Ensure that activities within the Cell Culture area are planned and executed to meet
business needs and Operations schedule.
• Responsibility for managing resources within Cell Culture unit operations of Pre-Culture,
Cell Culture, Media Preparation, Equipment Preparation and Weigh & Dispense.
• Providing leadership and direction to colleagues within the Cell Culture 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, PDMS and GTS activities related to Cell
Culture operations.
Main duties and responsibilities:
• Lead by example and strive to perform to high standards at all times in compliance with Credo and Standards of Leadership. Act as a role model for all colleagues within the Operations Department.
• Responsible and accountable for assuring the safe accomplishment of job activities in Operations Cell Culture and following good environmental practices and procedures
• Manage all activities within the Cell Culture function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Ensure that all activities within the Cell Culture function are planned and executed to meet business needs, customer needs and Operations schedule.
• Responsibility for managing resources within Cell Culture unit operations of Pre-Culture,
Cell Culture, Media Preparation, Equipment Preparation and Weigh & Dispense.
• Providing leadership and direction to colleagues within the Cell Culture function to ensure that goals, targets and expectations are communicated clearly.
• Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
• 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 colleague in departmental decisions, goal setting etc. Seek feedback from colleagues to ensure that needs are being met and to ensure proper focus of resources.
• Support to Commissioning, Qualification, Validation, PDMS & GTS activities.
• Pursue opportunities to develop colleagues within Cell Culture and other Operations functions.
• Ensure that housekeeping standards in Cell Culture areas and other areas within the Operations facility are maintained to a very high standard of GMP readiness.
• Manage resources of the Cell Culture function within budgetary constraints.
• Deputize to Cell Culture Team Leads and Team Co-ordinator as appropriate.
• Delegate responsibility and empower reports where appropriate to ensure personal effectiveness.
• Deputize for Purification Manager, Technical Operations Manager and Director of Operations as appropriate
• Ensure visibility in the Cell Culture Operations area through regular walkthrough of the area.
• Travel to JSC, J&J and other external sites as required for meetings, training etc.
Key Skills and Competencies required:
• Leadership and development of all colleagues within the Business Unit
• Customer focused and results driven
• Collaboration and teamwork across site functions and other JSC / J&J sites
• Demonstrate Integrity and Credo-based actions at all times
• Work as a strategic partner with all other departments within the company and to align across other JSC / J&J sites
Qualifications
Education and Experience:
ESSENTIAL
• Third level qualification in science or engineering discipline.
• Minimum of 5 years of experience within a pharmaceutical or GMP regulated Operations environment.
• Experience in supervison/management of people and resources.
DESIRABLE
• Operations experience within a Life Sciences or Biopharmaceutical Environment
• Experience of Cell Culture / Fermentation in an Operations environment.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Production