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For Companies At a Glance
- Tasks: Lead bioanalytical studies and develop innovative assays to improve patient lives.
- Company: Join a fast-growing CRO dedicated to advancing clinical development.
- Benefits: Competitive salary, career growth, and the chance to work on groundbreaking therapies.
- Why this job: Make a real impact in clinical research and collaborate with industry experts.
- Qualifications: Science degree and significant experience in regulated laboratory environments required.
- Other info: Dynamic team environment with opportunities for mentorship and professional development.
The predicted salary is between 60000 - 80000 £ per year.
Our Mission Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.
The Role We are seeking a Principal Scientist to join our Laboratory Services team, acting as a Subject Matter Expert with accountability for assigned bioanalytical studies and projects. The role is responsible for ensuring regulatory compliance and data integrity are maintained in line with company standards. You will lead the development and validation of bioanalytical assays, including ELISA-based methods, to analyse drugs, metabolites, and other analytes in biological samples generated from clinical trials, while maintaining accurate and contemporaneous data records. Working closely with Project Managers and other Principal Scientists, you will ensure studies are appropriately planned, resourced, and executed against key performance indicators of time, cost, and quality. As an ambassador for Laboratory Services, you will represent the function both internally and externally, including client and vendor interactions, support business development activities, and contribute to the ongoing development of colleagues within the department.
Key Accountabilities
- Provide technical advice to Business Development and participate in laboratory-related discussions with auditors, Sponsors and Simbec-Orion employees.
- Act as a Laboratory Services Ambassador for Simbec-Orion, presenting at conferences, trade shows, and academic institutes whilst demonstrating the department's expertise.
- Coordinate analytical studies from client onboarding to final reporting with accountability for the study’s regulatory compliance and scientific integrity.
- Develop methods of analysis in order to deliver fully validated assays.
- Support in mentoring and developing colleagues within the Laboratory Services department.
- Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment (e.g. GCP, EMA and FDA).
- Document procedures undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA+.
- Communicate the status of work performed with Laboratory Management, Laboratory Project Manager, and other team members.
- Produce or review/approve relevant documentation such as protocols, procedures, validation/study reports, SOPs, CAPAs, and file notes.
- Ensure all relevant study documents are delivered to the client and archived within expected timeframes.
- Ensure the required resources are available to properly perform research tasks and ensure efficient use of consumables and instrumentation.
- Maintain personal training records to demonstrate adequate competency for the position held associated responsibilities.
Essential Skills Required
- Science degree or equivalent
- Significant experience working within a regulated laboratory environment (e.g., MHRA GCP for labs, GLP or GMP)
- Significant experience in leading regulated studies to GCP, GLP and/or GMP guidelines
- Demonstrable ability to use and troubleshoot analytical processes/systems
- Demonstrable ability to develop and validate analytical methods
- Demonstrable ability to document laboratory information to a GXP standard
- Demonstrable ability to perform quality control processes
- Good organisation skills with the ability to prioritise work to meet deadlines
- Demonstrable experience in working to written instructions
- Excellent verbal and written skills, with the ability to tailor communication to a variety of internal and external stakeholders
- Track record of effective working within a team environment
Desirable
- MSc, PhD in a relevant discipline
- Experience in research work and/or relevant experience gained using similar scientific and analytical techniques
- Experience in streamlining and improving operational processes
- Project management/Six Sigma/Lean certification
- Good understanding of MHRA Phase I Accreditation scheme requirements
- In-depth knowledge of laboratory testing in a GLP/GMP/GCP environment
- In-depth knowledge of Laboratory Information Management Systems
About Us Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team. We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services we’re waiting to hear from you.
Principal Scientist in Merthyr Tydfil employer: Simbec-Orion
Contact Detail:
Simbec-Orion Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Scientist in Merthyr Tydfil
✨Tip Number 1
Network like a pro! Get out there and connect with industry professionals at conferences or local meetups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Show off your expertise! When you get the chance to chat with potential employers, don’t hold back on sharing your knowledge about bioanalytical studies and regulatory compliance. It’ll set you apart as a candidate who knows their stuff.
✨Tip Number 3
Be proactive! If you see a role that excites you, apply through our website and follow up with a friendly email. A little persistence can go a long way in showing your enthusiasm for the position.
✨Tip Number 4
Prepare for interviews by brushing up on your project management skills and understanding of GCP, GLP, and GMP guidelines. Being able to discuss these topics confidently will impress interviewers and show you’re ready to hit the ground running.
We think you need these skills to ace Principal Scientist in Merthyr Tydfil
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Principal Scientist role. Highlight your experience in regulated laboratory environments and any specific techniques you've mastered, like ELISA-based methods.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about improving patients' lives through clinical research. Share specific examples of how you've led projects or mentored colleagues, showing us your leadership skills.
Showcase Your Communication Skills: Since you'll be interacting with various stakeholders, it's crucial to demonstrate your excellent verbal and written communication skills. Use clear and concise language in your application to reflect this.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows your enthusiasm for joining our team!
How to prepare for a job interview at Simbec-Orion
✨Know Your Science
As a Principal Scientist, you’ll need to demonstrate your expertise in bioanalytical methods and regulatory compliance. Brush up on ELISA-based methods and be ready to discuss your experience with developing and validating assays. This will show that you’re not just familiar with the theory but can apply it practically.
✨Showcase Your Leadership Skills
You’ll be leading projects and mentoring colleagues, so highlight your leadership experience during the interview. Prepare examples of how you've successfully coordinated studies or guided team members in a regulated environment. This will help the interviewers see you as a strong candidate for the role.
✨Communicate Clearly
Effective communication is key, especially when interacting with clients and stakeholders. Practice explaining complex scientific concepts in simple terms. Be prepared to discuss how you tailor your communication style to different audiences, as this will be crucial in your role as an ambassador for Laboratory Services.
✨Prepare for Regulatory Questions
Since the role involves ensuring compliance with GCP, GLP, and GMP guidelines, expect questions about these regulations. Familiarise yourself with the latest updates and be ready to discuss how you’ve implemented these standards in your previous work. This will demonstrate your commitment to maintaining high-quality standards in laboratory practices.