Job Description
Job Overview
The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays (LBA), such as enzyme-linked immunosorbent assay (ELISA), to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic (PK) assays to measure drug and Immunogenicity assay to measure anti-drug antibodies (ADA) and neutralizing antibodies (NAb). Other assay types also performed are branched DNA (bDNA) and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery (MSD), Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.
Essential Functions (The fundamental Competencies/Skills & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
- Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
- Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong
- Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics
- Assist with providing costing estimates for components of applicable studies
- Provide short- and long-term solutions that support continuous improvement
- Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
- Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements
- Establish and review Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
- Develop and maintain contemporaneous knowledge of regulatory requirements
- Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
- Monitor performance metrics for operational area
- Function as a Principal Investigator, Individual Scientist, and/or Project Scientist as required by operational area or resourcing need
- Skillfully oversee the design, conduct, interpretation and reporting of studies
- Effectively utilize project management systems
- Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs
- Performs all other related duties as assigned
Job Description
- Bachelor’s degree or equivalent with 8-10 years of relevant experience. Between 3-4 years of management experience required
- Bioanalysis experience required
- Experience in a regulated environment required
- Experience in a Contract Resource Organization preferred
- Ability to communicate verbally and in writing at all levels inside and outside the organization
- Basic familiarity with Microsoft Office Suite
- Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
- Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
- Ability to work under specific time constraints
- Must be authorized to work in the United States without a sponsor visa, now or in the future.
The pay for this position is $115/year.
Physical Demands:
While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing, or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
Work Environment:
General office working conditions, the noise level in the work environment is usually quiet.
While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.