Clinical Method Development & Validations Lead TLNT1_NI in Newry

Clinical Method Development & Validations Lead TLNT1_NI in Newry

Newry Full-Time 46000 - 52000 £ / year (est.) No working from home possible
Norbrook Labs Ltd

At a Glance

  • Tasks: Lead method development and validation in a clinical lab, ensuring compliance with international guidelines.
  • Company: Join a leading bioanalytical company focused on innovation and quality.
  • Benefits: Competitive salary, career growth opportunities, and a supportive team environment.
  • Other info: Dynamic role with opportunities for mentorship and continuous improvement.
  • Why this job: Make a real impact in healthcare by developing cutting-edge bioanalytical methods.
  • Qualifications: Degree in Biochemistry or related field and 4+ years lab experience with chromatography.

The predicted salary is between 46000 - 52000 £ per year.

Permanent Location: Thursday 25 Jun

Main Activities/Tasks:

  • Subject matter expert in method development and validation.
  • Daily supervision, technical and managerial guidance of the Method Development and validation team.
  • Provide expertise and training to deliver methods and validations to facilitate delivery of the New Product Development bioanalytical programme.
  • Plan, lead and manage all bioanalytical method development and validation within the clinical laboratory in line with GLP, protocols, SOPs, VICH and other relevant international guidance.
  • Lead troubleshooting and root cause analysis of new and existing bioanalytical methods.
  • Write and approve Methods of Analysis for routine use within the laboratory.
  • Assessment of method performance after validation to identify and implement continuous improvements within the department.
  • Support preparation of documentation and responses to regulatory submissions and queries.
  • Assist in the preparation, implementation and review of GLP SOPs and ensure adherence to same within the laboratory.
  • Identify and implement continuous improvements within the department.
  • Hold regular team and one to one meetings to mentor, lead and further engage and support staff and build team skills.

Qualifications:

  • A relevant Biochemistry, Biomedical or other applicable Science based degree.
  • A minimum of 4 years' experience working in a laboratory environment with HPLC, UPLC, LCMSMS and frequent use of a chromatography data management system.
  • Good knowledge of Regulatory Guidelines.
  • Experience of preparing and reviewing validation protocols, SOMs & SOPs.

Desirable Criteria:

  • Experienced in DOE approach to method development.
  • Empower & Mass Lynx Chromatography Data management system experience.
  • GC experience.
  • Experience in regulatory inspections and preparing regulatory responses.
  • Knowledge of Regulatory Guidelines applicable to the GLP Laboratories.

Clinical Method Development & Validations Lead TLNT1_NI in Newry employer: Norbrook Labs Ltd

As a leading employer in the bioanalytical field, we offer a dynamic work environment that fosters innovation and professional growth. Our commitment to employee development is reflected in our comprehensive training programmes and supportive culture, where team collaboration and continuous improvement are at the forefront. Located in a vibrant area, we provide our staff with unique opportunities to engage in meaningful work that contributes to the advancement of healthcare solutions.

Norbrook Labs Ltd

Contact Details:

Norbrook Labs Ltd Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Clinical Method Development & Validations Lead TLNT1_NI in Newry

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We think you need these skills to ace Clinical Method Development & Validations Lead TLNT1_NI in Newry

Method Development
Method Validation
Technical Supervision
Bioanalytical Techniques
GLP Compliance
Troubleshooting
Root Cause Analysis

Some tips for your application 🫡

Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Norbrook Labs Ltd that you have the hands-on skills they need.

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Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Norbrook Labs Ltd does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.

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How to prepare for a job interview at Norbrook Labs Ltd

Brush Up on Lab Techniques

Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Norbrook Labs Ltd. You might even be asked to demonstrate your understanding of these processes.

Know Your Bioinformatics Tools

Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.

Show Your Teamwork Skills

Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Norbrook Labs Ltd's culture.

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