MSD Technical Specialist Biochemistry & Cell Biology 

Ireland 

754654502

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Develop lead and coach the Quality Control team in relation to the technical aspect of the lab activities and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Support the performance and optimisation of advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Works under minimal supervision.
• Prepare and update SOPs as required.
• Drive the development of technical skills through coaching and motivate a high performing culture across the team.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Support the preparation of laboratory protocol studies/validations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations.
• Consistently deliver on specific area Key Performance Indicators.
• Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A Master’s degree qualification in Science/Quality/Technical disciplines with 5 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) Or PhD with 3 years’ experience•
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Excellent trouble shooting and problem solving skills.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

Adaptability, Adaptability, Aseptic Manufacturing, Assay, Biochemical Assays, Cell-Based Assays, Cell Physiology, cGMP Compliance, Coach Team Members, Data Analysis, Decision Making, Documentation Review, Enzyme Linked Immunosorbent Assay (ELISA), FDA Regulations, GMP Compliance, Integrity Management, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Management Process, Quality Control Management, Quality Inspections, Quality Operations, Regulatory Compliance {+ 5 more}

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