Regulated Study Manager- Immunoassay in Fordham
Regulated Study Manager- Immunoassay

Regulated Study Manager- Immunoassay in Fordham

Fordham Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Oversee regulated Immunoassay studies and ensure high-quality data delivery.
  • Company: Leading bioanalytical firm focused on scientific excellence.
  • Benefits: Competitive salary, professional development, and a collaborative work environment.
  • Other info: Join a dynamic team dedicated to innovation and continuous improvement.
  • Why this job: Make a real impact in the field of bioanalysis while mentoring future scientists.
  • Qualifications: Degree in Biological Sciences or related field; experience in GxP labs preferred.

The predicted salary is between 36000 - 60000 £ per year.

Responsibilities

  • Provide end-to-end oversight of multiple regulated Immunoassay bioanalytical studies under GLP/GCP.
  • Robust scientific decision making in accordance with the EMA and FDA regulatory guidance.
  • Oversee method validation and sample analysis activities with scientific authority.
  • Serve as primary contact for clients, building strong partnerships and supporting programme progression.
  • Consistent on-time delivery of high-quality data and study reports to customers.
  • Adapt flexibly to challenges, identifying solutions to complex analytical and regulatory customer problems.
  • Mentor and guide scientists within the Immunoassay team, promoting scientific excellence and continuous improvement.

Skills, Education & Qualifications

  • Degree in Biological Sciences, Biochemistry, Immunology, or equivalent relevant experience.
  • Experience working in a GxP-accredited laboratory, preferably GLP or GCP.
  • Experience with immunoassay platforms (e.g., ELISA, ligand-binding assays, MSD) is advantageous.
  • Understanding of EMA and FDA bioanalytical method validation requirements.
  • Skilled communicator able to present scientific outcomes clearly to colleagues and clients.
  • Proactive, enthusiastic, quality-driven, and detail-focused, with a commitment to scientific integrity.

Regulated Study Manager- Immunoassay in Fordham employer: Resolian

As a Regulated Study Manager in our dynamic team, you will thrive in a culture that prioritises scientific excellence and innovation. We offer robust professional development opportunities, a collaborative work environment, and the chance to make a meaningful impact on client projects while adhering to the highest regulatory standards. Located in a vibrant area, our company fosters strong partnerships and encourages flexibility in overcoming challenges, making it an exceptional place for those seeking rewarding careers in bioanalytical science.
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Contact Detail:

Resolian Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulated Study Manager- Immunoassay in Fordham

✨Tip Number 1

Network like a pro! Reach out to professionals in the immunoassay field on LinkedIn or at industry events. Building connections can lead to job opportunities that aren’t even advertised yet.

✨Tip Number 2

Prepare for interviews by brushing up on your knowledge of GLP/GCP regulations and bioanalytical methods. We want you to be able to showcase your expertise and how it aligns with the role.

✨Tip Number 3

Don’t just apply; engage! When you submit your application through our website, follow up with a friendly email expressing your enthusiasm for the role. It shows initiative and keeps you on their radar.

✨Tip Number 4

Be ready to discuss real-world examples of how you've tackled challenges in previous roles. We love hearing about your problem-solving skills and how you’ve delivered high-quality results under pressure.

We think you need these skills to ace Regulated Study Manager- Immunoassay in Fordham

Regulatory Oversight
Scientific Decision Making
Method Validation
Sample Analysis
Client Relationship Management
Data Quality Assurance
Analytical Problem Solving
Mentoring and Guidance
Immunoassay Platforms (e.g., ELISA, ligand-binding assays, MSD)
Understanding of EMA and FDA Requirements
Effective Communication
Proactive Approach
Attention to Detail
Commitment to Scientific Integrity

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your experience in regulated studies and any relevant qualifications. We want to see how your background aligns with the role of Regulated Study Manager, so don’t hold back on showcasing your skills!

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about immunoassays and how your experience fits with our needs. Remember, we love a good story, so make it engaging!

Showcase Your Communication Skills: Since you'll be the primary contact for clients, it's crucial to demonstrate your communication prowess. Use clear and concise language in your application to reflect your ability to present scientific outcomes effectively.

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’s super easy – just a few clicks and you’re done!

How to prepare for a job interview at Resolian

✨Know Your Regulations

Familiarise yourself with the EMA and FDA regulatory guidelines related to bioanalytical studies. Being able to discuss these regulations confidently will show your understanding of the industry and demonstrate that you’re serious about compliance.

✨Showcase Your Scientific Expertise

Prepare to discuss your experience with immunoassay platforms like ELISA or ligand-binding assays. Bring specific examples of how you've applied your scientific knowledge in previous roles, especially in a GxP-accredited laboratory.

✨Build Rapport with Your Interviewers

Since this role involves serving as a primary contact for clients, practice your communication skills. Be ready to share how you've built strong partnerships in the past and how you can support programme progression effectively.

✨Demonstrate Problem-Solving Skills

Think of examples where you've faced complex analytical or regulatory challenges and how you adapted to find solutions. Highlighting your proactive approach and commitment to continuous improvement will resonate well with the interviewers.

Regulated Study Manager- Immunoassay in Fordham
Resolian
Location: Fordham

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