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Senior Scientist- Immunoassay (PK, PD, ADA) at Resolian
Fordham, England, United Kingdom -
Full Time

Start Date

Immediate

Expiry Date

03 Jan, 26

Salary

0.0

Posted On

05 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Immunoassay, Drug Development, FDA Regulatory Guidelines, Analytical Methods, Mentoring, Process Improvements, Attention to Detail, Communication, Biological Science, GXP Laboratory, Immunogenicity Assays, M10 Guidelines, Statistics, Sample Pretreatment, Automation, Hamilton

Industry

Biotechnology Research

Description
Responsibilities · 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.
Responsibilities
The Senior Scientist will build strong partnerships with customers to aid in drug development and ensure the timely delivery of high-quality analytical methods. They will also provide scientific decision-making in line with FDA guidelines and mentor team members.