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Senior Associate Scientist

  • Título Senior Associate Scientist
  • Función R&D
  • Sub función R&D
  • Ubicación Cork, Ireland
  • Publicado
  • Identificación requerida (Req ID) 2306108950W
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Position Title: BTDS AD -Senior Associate Scientist

Department: Discovery, Product Development and Supply; BioTherapeutics Development & Supply Analytical Development – (DPDS, BTDS-AD)

Report to: Team Lead, Separation Sciences

Location: Cork

Travel : 5-10%

Global Compensation Framework Band Number: 25

Company Summary: Janssen Sciences Ireland UC is a pioneer in the use of mammalian cells to manufacture monoclonal antibodies. €537 million was invested in Cork to build a manufacturing facility to produce the next generation of fully humanized antibodies. The Cork facility was the largest green field start up ever undertaken by J&J.

BioTherapeutics, Development and Supply (BTDS) Analytical Development (AD) group is a department of Discovery, Product Development and Supply, Janssen R&D organization. The department is responsible for Tox release testing, Clinical release and stability testing for drug substance and drug product, chamber and sample handling and stability management. The AD department in Cork, Ireland, is responsible for analytical support for large molecules.

Position Summary:

Reporting to one of three Separation Sciences Technology Team Leads (HPLC, cIEF and cSDS), the person will participate in various projects, focused on Separations based assays and associated analytical techniques, while being responsible for testing and resolution of product related issues in support of the Separation Sciences team. They will partner with other AD teams and departments to ensure that all BTDS AD activities are completed in an efficient manner.

Main duties and responsibilities:

  • Co-ordination and execution of routine release and stability testing Separations Methods for pre-clinical and clinical product development.
  • Analytical Technology Transfer activities.
  • Testing to support assay validation/qualification and other studies.
  • Review, interpretation, and trending of Laboratory generated data.
  • Review operation and maintenance of laboratory equipment.
  • Completion of documentation in adherence to GMP.
  • Participates in Technical discussions with AD Method development group.
  • Promotes a continuous improvement culture and participates in continuous improvement projects.
  • Supports troubleshooting and laboratory investigations.
  • Perform Data Trending to support investigations, demonstrate method capability and product profile.
  • Write SOP’s, protocols, work instructions and training modules.
  • Promotes a continuous improvement culture
  • Ensures trainings are completed on time and all tasks are performed only after completion of trainings on current effective procedures.
  • Perform laboratory support activities as per training and perform tasks related to audit readiness.
  • Is an active member of team and aids with other group activities as required and communicates relevant issues to the BTDS AD Team Leader and Manager.
  • Supports non-conformances/ deviations in an accurate and timely manner.
  • Maintains and develops knowledge of analytical technology as well as cGMP Standards.
  • Other duties as assigned by team lead



Key Skills and Competencies required:

  • Collaboration and teamwork.
  • Demonstrates leadership
  • Strategic thinker.
  • Problem solving and attention to detail.
  • Results and performance driven.
  • Integrity, trustworthiness, and objectivity.
  • Customer focus.
  • Clear interpersonal and communication skills.
  • Adaptable and flexible.
  • Proven Separations expertise particularly with size exclusion and capillary methodologies.
  • Experience with Method Development/Transfer/ Validation
  • Familiar with applicable cGMP and other business compliance regulations.
  • Ability to work well within team structures and provide leadership.

Education and Experience:

  • A minimum of a Degree in Molecular Biology, Biochemistry, Pharmacy, or related scientific field is required.
  • Proven experience (4 to 8 years) in a laboratory-testing environment within the biological and/or pharmaceutical industry. Advanced degree (MSc) advantageous.
  • Knowledge of computer systems/programs e.g LIMS, Empower, MS Word, Excel.
  • Strong understanding of quality and attention to detail.
  • Demonstrated knowledge and testing experience in an FDA/IMB approved laboratory.

Significant Safety or Working Considerations:

All employees are required to follow the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:

  • Take reasonable care to protect themselves and the safety of their colleagues who may be affected by their actions.
  • Follow EHS rules and procedures at all times.
  • Understand the potential EHS impact of their activities.
  • Attend and participate in EHS training as required.
  • Use PPE and safety equipment as required.
  • Report all incidents, accidents, and near miss events.
  • Report unsafe plant, equipment, acts, procedures, or issues.
  • Make suggestions to improve health and safety in the workplace.
  • Actively participate in work area EHS teams.
  • Not turn ignore unsafe acts or situations.


This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this description at any time, or to vary the duties and responsibilities to meet production, scheduling, or other business needs.

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