Sr. Scientist Immunoassay

Resolian•Malvern, AR

About The Position

Responsibilities · Act as a Subject Matter Expert (SME), leading strategy, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, ECL/MSD, Gyrolab, PCR, and/or flow cytometry) for both regulated and non-regulated sample testing, data analysis and study reporting. · Serve as the Principal Investigator (PI), lead a team of scientists and delegate work properly, providing strategic bioanalytical guidance and consultation for pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker studies. · Present and interpret data/results with scientific rigor and regulatory alignment, both internally and externally, ensuring clarity and accuracy. · Collaborate effectively with clients, ensuring high satisfaction through timely communication, responsive service, and the on-schedule delivery of high-quality results. · Draft, review, and finalize laboratory data and controlled documents, including bioanalytical methods, study plans and reports. · Provide mentorship and technical guidance to junior staff and collaborators. · Support laboratory operations and resource allocation and collaborate across teams, departments, and sites to improve quality and efficiency · Collaborate with Business Development to assess client requests and advise on feasibility. · Represent the team in the development and continuous improvement of policies, procedures, work instructions, and standard operating procedures (SOPs). · Ensure adherence to internal standards and regulatory requirements, including Code of Conduct, Environmental Health and Safety (EHS), GLP/GCP/GDP/21 CFR Part 11, and relevant guidelines from authority bodies like FDA and EMA. · Represent the Immunoassay department during audits and client meetings Perform additional duties as needed to support team objectives and organizational goals.

Requirements

PhD or master’s degree in biology, immunology or relevant field with 5-10years of industrial experience on regulated bioanalysis
Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP, and so on
Excellent knowledge and understanding of the pharmaceutical industry
Able to work effectively and contribute/lead within a team
Able to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
Excellent ability to lead complex studies, manage timelines, and communicate effectively with clients and cross-functional teams
Able to work with computer systems
Able to document clearly

Responsibilities

Act as a Subject Matter Expert (SME), leading strategy, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, ECL/MSD, Gyrolab, PCR, and/or flow cytometry) for both regulated and non-regulated sample testing, data analysis and study reporting.
Serve as the Principal Investigator (PI), lead a team of scientists and delegate work properly, providing strategic bioanalytical guidance and consultation for pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker studies.
Present and interpret data/results with scientific rigor and regulatory alignment, both internally and externally, ensuring clarity and accuracy.
Collaborate effectively with clients, ensuring high satisfaction through timely communication, responsive service, and the on-schedule delivery of high-quality results.
Draft, review, and finalize laboratory data and controlled documents, including bioanalytical methods, study plans and reports.
Provide mentorship and technical guidance to junior staff and collaborators.
Support laboratory operations and resource allocation and collaborate across teams, departments, and sites to improve quality and efficiency
Collaborate with Business Development to assess client requests and advise on feasibility.
Represent the team in the development and continuous improvement of policies, procedures, work instructions, and standard operating procedures (SOPs).
Ensure adherence to internal standards and regulatory requirements, including Code of Conduct, Environmental Health and Safety (EHS), GLP/GCP/GDP/21 CFR Part 11, and relevant guidelines from authority bodies like FDA and EMA.
Represent the Immunoassay department during audits and client meetings
Perform additional duties as needed to support team objectives and organizational goals.