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Research Scientist – Immunological Method Development

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Job Details
Job Order Number
Company Name
Physical Address
Newark, DE 19711
Job Description

The Research Scientist is an advanced scientific contributor in the laboratory Operations unit within QPS, Department of Translational Medicine (TLM).

Candidate will devise or understand experimental designs, analyze and evaluate results, develop and introduce new techniques and assays, and interact with sponsors to complete immunogenicity or immunobioanalytical studies. As Principal Investigator, incumbent will fill the role of Technical Leader, and be responsible for completing portions of, or complete, projects, and providing quality and timely results.

The role requires wet lab invention and creative thinking. Additional technical requirements include data reduction and evaluation, as well as assessing and introducing new techniques and assays. As Principal Investigator, incumbent will fill the role of Technical Leader, and be responsible for completing projects or portions of projects, and providing quality and timely results and GLP documentation.

Though a specialist in a laboratory Operations team, Research Scientists experience multiple daily interactions and troubleshooting opportunities with operations staff, and vendors and clients. Research Scientists are trained and supported by process and technical experts as well as the department director / subject matter expert.
Essential Functions
- Coordinate with client and internal resources to plan, design and conduct studies.
- Independently design and help manage the development, optimization and validation of analytical methods, including ELISA, MSD or cell based assay, to support drug development
- Prepare, and/or review study protocols that are scientifically sound and with compliance consideration.
- Maintain schedule of projects and timelines. Coordinate study activities to ensure efficiency and quality.
- Communicate project timelines, status, data, reports, and inquiries to client and/or study sites, effectively addressing any issues that may arise.
- Lead effort in implementation of new biological assays and processes, as well as in trouble-shooting various bio-chemical procedures.
- Lead team in method development and validation in various assays, including ELISA, cell-based neutralizing antibody (Nab) assay, etc.
- Collaborate with internal departments for timely sample analysis and results, assessment, and technology transfer.
- Simultaneously handle multiple method development & routine sample analysis projects.
- Perform high-volume sample analysis and/or data analysis, data QC, and data interpretation.
- Proactive, strategic project planning and organization to meet study timelines.
- Set-up, utilize, and maintain complex instrumentation
- Prepare materials for presentations and publications.
- Supervise, train and/or mentor junior scientific staff.
- Maintain tools, computer programs, and SOPs required for studies.
- Research literature and external sources and identify new techniques and procedures that strengthen QPS’ capabilities.

Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)
- Self-motivated
- Initiative
- Creative Thinking
- Development orientation
- Flexible
- Leadership skills
Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)
- Experience in pharmacokinetic and immunogenicity assay preferred.
- Cell culture experience is a plus.
- Understanding of experimental design and planning, and data collection and analysis software.
- Demonstrated supervisory ability.
- Proven ability to successfully work in a team environment.
- Excellent oral and written communication skills.
- Ability to make independent decisions.
- Experience or knowledge of GLP regulations is a plus.
- May be Principal Investigator and/or Study Director for one or more phases of studies (formulation, in-life, analysis) and assist in other phases.
- When assigned as Principal Investigator or Study Director, work with sponsor and internal resources to plan, design, and coordinate conduct of studies.

Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)
- Ph.D. in Immunology, Biochemistry, Medical Technology or related scientific discipline, with at least
2 years of relevant experience, OR
- Master’s or Bachelor’s Degree in same disciplines with equivalent relevant experience.

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