Manager- Immunotox

Job Summary

The Immunology & 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 anti0drug antibodies (ADA) and neutralizing antibodies (Nab).  Other assay types 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

• 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, trouble shooting, and time management skills aligned with needs of operational areas
• Demonstrate effective communication skills through informal discussion 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 needs
• Skillfully oversee the design, conduct, interpretation and reporting of studiesEffectively 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 Qualifications

• Bachelor's degree with 8-10 years of relevant experience.  

• PhD Preferred.

• 3-4 Years of management experience required

• 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

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:
Genal office work conditions, the noise level in the work environment is usually quiet.  
While performing the duties of this job the employee may occasionally he 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 employe may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.

The pay range for this position is $95K - $115K/year.  Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.