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Job Description:

Therapeutics Development & Supply, Analytical Development (TDS-AD) Cork, is a department responsible for the clinical release and stability testing of drug substance and drug product materials and stability management of the large molecule (therapeutic proteins) portfolio. In addition to clinical release & stability activities, TDS-AD Cork is responsible for analytical support of large molecules through analytical method transfer, evolving method knowledge as part of the product lifecycle and investigations and manufacturing support.

This job description will outline the role of the Associate Manager Biologics AD who will be responsible for people leadership and talent development of a team of scientists that are responsible for the release and stability testing activities with particular emphasis on identity and process impurity assays:

Position Summary:

Reporting to the Manager, Bioassay and Advanced Therapy Stability Sciences (TDS-AD) Cork, the person will be focused on the validation and testing of process impurity related assays (Residual Protein A, Residual HCP and Residual DNA), Identity assays (Dot blot) & release testing of the large molecule clinical pipeline and be responsible for the resolution of product related issues. Data monitoring, method optimization, trouble shooting and assessing the impact of new product matrices to assay performance 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 impurity assays (Residual DNA, Residual Protein-A, & Residual HCP), Identity and release samples for the Bioassay 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.

• Co-ordinates and plans activities related to the successful transfer/qualification 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.

Key Skills and Competencies required:

• 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.

Education and Experience:

• A minimum BSc degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Sciences, Bioengineering.

• A minimum of 5-7 years’ experience within the pharmaceutical industry.

• Technical expertise in analytical technologies pertinent to process impurity assays (e.g. ELISA/binding assays and qPCR) and Identity assays (e.g. Dot Blot).

• Knowledge of the biopharmaceuticals manufacturing process and the relationship to process impurity testing and data interpretation.