At a Glance
- Tasks: Lead a dynamic team in managing laboratory activities and ensuring compliance with GMP standards.
- Company: Join a leading pharmaceutical company focused on innovation and quality.
- Benefits: Enjoy a permanent position with opportunities for professional growth and development.
- Other info: Collaborative environment with a focus on continuous improvement and team training.
- Why this job: Make a real impact in pharmaceutical development while working with cutting-edge analytical methods.
- Qualifications: Degree in a science discipline and 4 years of experience in a cGMP environment required.
The predicted salary is between 36000 - 44000 £ per year.
The successful candidate will manage a small team, alongside the wider analytical Pharmaceutical Development group and oversee the day-to-day running of the laboratory. The role will require the candidate to work on a range of projects including both New Product Development and remediation support for existing finished product methods. The candidate will manage both chemical and physical testing to support both the introduction of new products and where required the lifecycle management of existing products. The candidate will actively assist the regulatory affairs department in responses to regulatory bodies related to analytical methods and results to ensure successful submission of new products. The candidate will liaise with the Quality assurance team regularly, ensuring a high GMP standard of all analytical raw data and documentation within the department.
Main Activities/Tasks
- Effective management of team ensuring staff have the skills necessary to operate within their required competency level as per key skills matrix.
- Manage laboratory activities and personnel to ensure GMP compliance and the laboratory is audit ready at all times.
- To compile and report analytical results taking into consideration internal SOPs, V(ICH) guidelines, Pharmacopeial Monographs and appropriate regulatory guidance's and legislation as applicable.
- Direct Analytical method development, validation and transfer of finished product stability indicating methods.
- Support the analytical testing of pre-approval process validation batches and to engage in any root cause analysis investigations and Risk assessment review.
- Schedule stability study analysis, covering the full V(ICH) study design.
- To troubleshoot projects which necessitate technical analytical input as they arise across the company not limited to R&D projects.
- To schedule team activities within the laboratory to ensure work is carried out in support of projects to agreed timelines.
- To lead trending of analytical data and approve investigations for out of specification results in accordance with company procedures.
- To identify areas for continuous improvement within the team and highlight to department management.
- Oversee training of new and existing laboratory staff, maintenance of associated training records, and identification of training requirements.
- Support preparation and review of Standard Operating Procedures, MOA's, report books and technical documentation.
- To maintain an awareness of current guidelines (USP, Ph Eur, (V)ICH), and industry best practice for stability and process validation studies of pharmaceutical products.
- To oversee and manage the overall performance of the analytical team and direct reports.
Essential Criteria:
- Educated to degree level in a science related discipline.
- At least 4 years previous experience working in a cGMP environment.
- HPLC, UPLC, GC and practical wet chemistry experience.
- Knowledge of VICH guidance for Method Validation of Finished product methods, Process validation and Stability studies.
Desirable Criteria:
- Post graduate qualification.
- Mass spectrometry experience.
- At least 1 year GMP laboratory experience in a supervisory role.
- Previous analytical Method Development and Validation experience.
- Knowledge of AQbD principles.
- Finished product stability study experience.
- Knowledge of Process validation for pre-approval studies.
- Experience with troubleshooting relevant lab equipment; HPLC, UPLC, GC etc.
To Apply Please forward your CV via the APPLY Now button below.
R&D Analytical Team Lead TLNT1_NI in Newry employer: IrishJobs
As a Waste Resource Team Leader with our esteemed local authority client, you will be part of a dedicated team committed to enhancing community sustainability and environmental responsibility. Our organisation fosters a supportive work culture that prioritises employee development, offering training opportunities and a clear path for career progression. With competitive remuneration, including pension and holiday pay, along with the chance to make a meaningful impact in your community, this role is an excellent opportunity for those seeking rewarding employment in the public sector.
StudySmarter Expert Advice🤫
We think this is how you could land R&D Analytical Team Lead TLNT1_NI in Newry
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We think you need these skills to ace R&D Analytical Team Lead TLNT1_NI in Newry
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at IrishJobs!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show IrishJobs that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at IrishJobs!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At IrishJobs, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at IrishJobs
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at IrishJobs that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with IrishJobs’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
