Senior Supervisor (Team Lead) Biologics AD

Reporting to the Associate Director/Senior Manager, Separation Sciences (TDS-AD) Cork , the person will be focused on release testing of the large molecule clinical pipeline and be responsible for the resolution of product related issues. Data monitoring, method optimization, investigations, trouble shooting and strong communication with our partners within TDS will also form a key part of the role.

Given the diversifying of the Johnson and Johnson clinical portfolio, this may include a diverse class of molecules/entities including monoclonal antibodies, bis-specific antibodies, antibody drug conjugates and advanced therapeutic medicinal products (ATMP's).

This individual should demonstrate technical leadership in analytical technologies and stability sciences and will represent the department on cross-functional and external teams and act as a technical expert.

Main duties and responsibilities:

• Manage the laboratory testing of a wide range of large molecule biologics across the Separations technologies.

• 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.

• Co-ordinates and plans activities related to the successful transfer/qualification/validation of analytical methods for clinical products in partnership with the method development group.

• Collaborate with the method development group to ensure alignment between transferring and receiving lab and to increase the technical capability and knowledge of the AD Cork team.

• Anticipate and plan for future equipment and resource requirements within the group.

• Report on key performance indicators for the group.

• Act as AD Cork point of contact for tactical supply/batch release to ensure on-time delivery for the clinical supply unit.

• 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 AD Cork where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.

• Problem solving and attention to detail. Efficient, flexible and dynamic.
• Ability to contribute to area management operational and strategic initiatives.
• Ability to foster team productivity and cohesiveness and to work collaboratively in a matrixed global environment.
• Ability to involve all team members in the planning and delivery of results to ensure all team members are fully aligned.
• Coaching and mentoring style
• Customer focused and results driven.

• A minimum of a BSc degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Sciences, Bioengineering.
• A minimum of 3-5 years' experience within the pharmaceutical industry.
• Technical expertise in Separations and/or excipient analytical technologies).
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• Knowledge of the biopharmaceuticals manufacturing process and the relationship to process impurity testing and data interpretation.