Senior Scientist, Immunoassay (PK, PD, ADA)

Resolian Inc.; United Kingdom; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A leading biopharmaceutical company in the United Kingdom seeks a committed professional to lead a team of scientists. The role involves developing robust analytical methods and ensuring compliance with FDA regulations in a GXP accredited environment. Candidates should possess a degree in biological science, foster strong customer relationships, and demonstrate exceptional problem-solving and communication skills. This is an opportunity to drive impactful change within drug development processes, while mentoring emerging talent in the field.

Qualifications

• Experience leading and mentoring scientists.
• Enthusiastic and proactive in suggesting process improvements.
• Excellent attention to detail and focus on quality.
• Ability to effectively communicate experimental outcomes.
• Experience in a GXP accredited laboratory is beneficial.
• Expertise in developing and validating immunogenicity assays.
• Familiarity with M10 and FDA regulatory guidelines.
• Good understanding of statistics for cut point generation.
• Practical experience with sample pretreatment strategies.

Responsibilities

• Build partnerships with customers to enhance drug development.
• Make scientific decisions per FDA guidelines.
• Design and deliver clinical analytical methods.
• Ensure timely high-quality method delivery.
• Adapt and find solutions to customer problems.

Skills

Leadership and mentoring

Attention to detail

Process improvement

Effective communication

Problem-solving

Education

Degree in biological science or equivalent

Tools

MSD platforms

Gyrolab systems

Hamilton automation

Job description

• Build strong partnerships with our customers to help them progress their drug development pipeline
• Strong scientific decision making in accordance with the FDA regulatory guidances
• Help to design and deliver robust pre-clinical and clinical analytical methods within the PK, PD & ADA team
• Ensure on time delivery of high quality methods to your customers
• Ability to adapt, be flexible and find solutions to our customers problems

Skills, Education & Qualifications

• Be able to lead and mentor scientists within your team
• Be enthusiastic, proactive, and willing to suggest and implement process improvements
• Focus on quality, and possess an excellent attention to detail
• Communicate effectively; explaining the outcome of experiments to peers and customers
• a degree in biological science, or equivalent relevant experience
• Experience in a GXP accredited laboratory is advantageous
• Expertise in the development and validation of immunogenicity assays on a variety of platforms, principally MSD but also Gyrolab.
• Awareness of M10 and FDA regulatory guidelines
• Have good understanding of the statistics underlying cut point generation
• Practical experience with a variety of sample pretreatment strategies, including SPEAD and ACE.
• Familiarity with automation, use of the Hamilton is a plus.