Validation Scientist

Job Description The incumbent will work as part of the validation team to support all validation and life cycle activities of Pharmacokinetic (PK), Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb) assays for the development of biological drugs. Job # 3049393 Key Responsibilities / Essential Functions Coordinate, plan, and execute NAb and/or ADA assay validations by actively collaborating with team members from method development group to deliver validated methods for bioanalysis support. Support immunoassay and cell-based assay platforms with laboratory skills to execute experiments when needed. Provide input and identify problems with scientific experiments, analyses/tasks in related areas. Produce documents to support PK, ADA and NAb assay validations Qualifications M.S. with 2-4 years of experience or a B.S./B.A. with 3-6 years of experience in Biology or related field. Experience with immunoassay and cell-based assays used in the ADA, NAb, or PK bioanalysis of biologic drugs is highly preferred. Experience in a GxP environment is required. Prior experience in pharmacokinetic and ADA bioanalysis and method validation is preferred. A high level of computer proficiency in Microsoft Office suite and writing skills is required. Experiences with automated data analysis, electronic lab notebook, Watson Laboratory Information System, AI tools, and statistical tool. Excellent communication skills and the ability to perform effectively in a fast-paced environment required. About the Company Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Benefits Overview Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide. Equal Opportunity Employment Everforth Apex is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Accommodation for Applicants If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at [email protected] or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered. #J-18808-Ljbffr Apex Systems