Scientist II (LBA)
US - Malvern, United States
JOB DESCRIPTION
Responsibilities
Serve as the Principal Investigator (PI), leading the design, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, MSD, qPCR/RT-qPCR, flow cytometry) for both regulated and non-regulated pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker sample testing, data analysis and study reporting.
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 study plans and reports.
Support laboratory operations and provide mentorship and technical guidance to junior staff and collaborators.
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. Perform other duties as needed.
P
Skills, Education & Qualifications
BA/BS or higher with 9-10 years lab experience; all experiences will be evaluated
PhD in relevant field with 2-3 years industrial experience
Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
Able to independently perform complex lab work
Able to work in a regulated environment
Able to work effectively and contribute within a team
Able to work with computer systems
Able to document clearly; knowledge of and experience in a regulatory environment
ABOUT US
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
JOB INFO
Job Identification
285
Posting Date
06/02/2025, 07:05 AM
Job Schedule
Full time
Locations
17 Lee Blvd, MALVERN, US
US - Malvern, United States
JOB DESCRIPTION
Responsibilities
Serve as the Principal Investigator (PI), leading the design, development, validation, troubleshooting, and implementation of bioanalytical methods (e.g., ELISA, MSD, qPCR/RT-qPCR, flow cytometry) for both regulated and non-regulated pharmacokinetics, immunogenicity (ADA and Nab), and/or biomarker sample testing, data analysis and study reporting.
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 study plans and reports.
Support laboratory operations and provide mentorship and technical guidance to junior staff and collaborators.
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. Perform other duties as needed.
P
Skills, Education & Qualifications
BA/BS or higher with 9-10 years lab experience; all experiences will be evaluated
PhD in relevant field with 2-3 years industrial experience
Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
Able to independently perform complex lab work
Able to work in a regulated environment
Able to work effectively and contribute within a team
Able to work with computer systems
Able to document clearly; knowledge of and experience in a regulatory environment
ABOUT US
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
JOB INFO
Job Identification
285
Posting Date
06/02/2025, 07:05 AM
Job Schedule
Full time
Locations
17 Lee Blvd, MALVERN, US
Job ID: 480106329
Originally Posted on: 6/6/2025
Want to find more Chemistry opportunities?
Check out the 17,664 verified Chemistry jobs on iHireChemists
Similar Jobs
Sign Up for Job Alerts
