Associate Director LBA

About the role

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.

Responsibilities

• Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training and developing employees
• 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
• Maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Demonstrate effective communication skills through informal discussions with peers, supervisor, team, cross-site, and externally with collaborators and sponsors
• Review and approve Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures
• Maintain contemporaneous knowledge of regulatory requirements
• Effectively plan, assign and direct work within one operational area with expanded scope and/or complexity
• Establish and monitor performance metrics for operational area
• 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
• Align operational resources with the current needs in one operational area
• Manage cross-service line interdependencies in collaboration with organizational leadership
• Collaborate with multiple departments within site
• Lead planning (resource management, budgets and study coordination) as well as track budgets and spend vs. revenue for one operational area
• Collaborate and consult with prospective Sponsors, providing scientific expertise and developing ongoing Sponsor relationships
• Provide leadership, expert consultation and mentorship to cross-functional company teams

Qualifications

• Bachelor’s degree in a scientific field with 11-14 years of relevant experience
• 5-7 years of management experience required
• CRO experience preferred
• Bioanalysis experience preferred

Physical Demands

• 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
• Occasionally exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions

Pay

The pay range for this position is $135-150k/year.

Schedule

Position is 100% on site in Mattawan, MI