PDMS CRS Team Lead-1424487W
Description
Position: PDMS-CRS Laboratory Lead
Department: Pharmaceutical Development and Manufacturing Sciences – Analytical Development – Clinical Release and Stability (PDMS-AD CRS)
Report to: PDMS-CRS Sr. Manager
Location: Cork
Travel: 10%
Global Compensation Framework Band Number: 26
Position Summary
Global Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). The department is responsible for Clinical Stability Management and Clinical Release/Stability testing of drug substance and drug product, as well for Small Molecules as for Large Molecules.
The Clinical Release & Stability Department in Cork, Ireland, is responsible for the biotechnology scope of the PDMS product portfolio.
Main Duties and Responsibilities
• Manage the laboratory testing of clinical stability and release samples for the Separations Technology team.
• Drive and support a proactive safety culture within the Laboratory.
• Ensure laboratory activities are carried out in compliance with cGMP and appropriate
regulatory standards.
• Motivate and develop reports in addition to developing and setting measurable and challenging goals for the group and enable regular constructive feedback through the PC&D process.
• Co-ordinates and plans activities related to the successful transfer of Analytical methods for relevant NMEs in partnership with the Large molecule method development group.
• Collaborate with the LMMD group to ensure alignment between CRS and LMMD and to increase the technical capability and knowledge of the CRS Cork team.
• Anticipate and plan for future equipment and resource requirements within the group.
• Report on Key performance indicators for the group.
• Promote a Lean/CI culture and identify and drive improvement initiatives.
• Work with site QA colleagues to increase the scope of the Adaptive Quality process.
• Participate in regulatory and internal audits as required.
• Drive laboratory investigations in a comprehensive and timely manner.
• Communicate effectively so that all relevant stakeholders are kept informed of potential bottlenecks, resource requirements and project progress.
• Represent CRS Cork where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
Qualifications
Education and Experience/Competencies
• A minimum of Master’s degree in Chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent through experience.
• A minimum of 5 years’ experience within the pharmaceutical industry.
• Experience in ‘large molecule’ analytical technology with particular emphasis on separations technologies.
• Proven Lean experience (Lean qualification would be an advantage)
• Project management and problem solving skills.
• Problem solving and attention to detail.
• Ability to foster team productivity and cohesiveness and to work collaboratively in a global matrix environment.
• Coaching and mentoring style
• Customer focus and result driven.
• Efficient, flexible and dynamic.
• Excellent communication skills.
• Strategic thinking
• Work effectively with people that have diverse styles, talents and ideas
NB: The position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all the elements of the position. Management reserves the right to modify the position description at any time, or to vary the duties and responsibilities of the position to meet business needs
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: R&D
Description
Position: PDMS-CRS Laboratory Lead
Department: Pharmaceutical Development and Manufacturing Sciences – Analytical Development – Clinical Release and Stability (PDMS-AD CRS)
Report to: PDMS-CRS Sr. Manager
Location: Cork
Travel: 10%
Global Compensation Framework Band Number: 26
Position Summary
Global Clinical Release & Stability is a department of Pharmaceutical Development and Manufacturing Sciences – Analytical Development (PDMS-AD). The department is responsible for Clinical Stability Management and Clinical Release/Stability testing of drug substance and drug product, as well for Small Molecules as for Large Molecules.
The Clinical Release & Stability Department in Cork, Ireland, is responsible for the biotechnology scope of the PDMS product portfolio.
Main Duties and Responsibilities
• Manage the laboratory testing of clinical stability and release samples for the Separations Technology team.
• Drive and support a proactive safety culture within the Laboratory.
• Ensure laboratory activities are carried out in compliance with cGMP and appropriate
regulatory standards.
• Motivate and develop reports in addition to developing and setting measurable and challenging goals for the group and enable regular constructive feedback through the PC&D process.
• Co-ordinates and plans activities related to the successful transfer of Analytical methods for relevant NMEs in partnership with the Large molecule method development group.
• Collaborate with the LMMD group to ensure alignment between CRS and LMMD and to increase the technical capability and knowledge of the CRS Cork team.
• Anticipate and plan for future equipment and resource requirements within the group.
• Report on Key performance indicators for the group.
• Promote a Lean/CI culture and identify and drive improvement initiatives.
• Work with site QA colleagues to increase the scope of the Adaptive Quality process.
• Participate in regulatory and internal audits as required.
• Drive laboratory investigations in a comprehensive and timely manner.
• Communicate effectively so that all relevant stakeholders are kept informed of potential bottlenecks, resource requirements and project progress.
• Represent CRS Cork where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
Qualifications
Education and Experience/Competencies
• A minimum of Master’s degree in Chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent through experience.
• A minimum of 5 years’ experience within the pharmaceutical industry.
• Experience in ‘large molecule’ analytical technology with particular emphasis on separations technologies.
• Proven Lean experience (Lean qualification would be an advantage)
• Project management and problem solving skills.
• Problem solving and attention to detail.
• Ability to foster team productivity and cohesiveness and to work collaboratively in a global matrix environment.
• Coaching and mentoring style
• Customer focus and result driven.
• Efficient, flexible and dynamic.
• Excellent communication skills.
• Strategic thinking
• Work effectively with people that have diverse styles, talents and ideas
NB: The position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all the elements of the position. Management reserves the right to modify the position description at any time, or to vary the duties and responsibilities of the position to meet business needs
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: R&D