Newark Metro Area, New Jersey
The role of the Biologics BA/DMPK Department is to provide sample analysis support to discovery teams focused on identifying biologics for the treatment of severe unmet medical needs in oncology, inflammation, autoimmunity and fibrosis. BA/DMPK department also contributes to development teams by providing preclinical and clinical data to support the clinical development plan. BA/DMPK is responsible for the development, validation and implementation of ligand binding based immunoassays (ELISA/ECL) to characterize the pharmacokinetics and immunogenicity of lead biologics. Members of the department provide leadership for programs from discovery to marketing authorization. There is a close working relationship with Pharmacology, Toxicology, Clinical and Translational Development.
Reporting to the Director, the candidate will have responsibility for:
The design, planning, execution and interpretation of immunoassays for measurement of drug concentration in biological matrices such as serum.
Will drive scientific excellence and lead by example in the lab by demonstrating best practices in the development, implementation and execution of assays.
Will be expected to support multiple projects and will be responsible for communicating data within the department.
Will have the opportunity to participate in group meetings and work alongside Principal Scientists.
Candidate must have strong written and oral communication skills, be self-motivated, a team player.
Proven track record in implementing ELISA and/or ECL based immunoassays for the development of biologics.
Advanced laboratory bench skills such as ELISAs, Western blots, qPCR or FACS.
Proven track record of good experimental design, data analysis and interpretation.
Able to problem solve and offer potential solutions.
Excellent written and oral communication skills.
Works independently or as part of a team, with some guidance from Principal Scientists.
Computer skills: detailed knowledge of Excel, Word, Powerpoint and Graphpad prism.
Design, plan, execute and interpret immunoassays (with guidance) to evaluate pharmacokinetics of biologics.
Evaluation of immunogenicity via techniques such as ELISA and Mesoscale/ECL.
Manage inventory of reagents and order supplies as necessary using oracle procurement system.
Maintain detail records of laboratory experiments using electronic laboratory notebook or paper records as necessary.
Plan, execute and interpret pharmacokinetic studies under the supervision of Principal Investigators.
Data presentation to multidisciplinary teams.
Participate in the design and development of experiments to address issues or troubleshoot.
Preparation of technical reports, slides for presentations, graphs and tables for recording data.
Interface with cross-functional team members
Interact with members of the laboratory and share responsibility for maintenance of safe working environment.
BS or MS in pharmacology, biology or relevant scientific discipline; minimum 1-2 years of industrial or relevant academic experience.
Must be a broadly experienced in laboratory skills and demonstrates good communication skills, is highly flexible, results-oriented, who enjoys working in a fast-paced environment.
Responsible for the design, planning, execution and interpretation of immunoassays for the evaluation of pharmacokinetics and immunogenicity of biologics.
Candidate will be expected to lead by example and learn from fellow scientists. Additional responsibilities include participation in discussion of data, presentation of data to teams and generation of technical reports.