EIA Product Line Manager

IMMY•Norman, OK

About The Position

The EIA Product Line Manager leads the continuous, on-time production of IMMY’s 96-well plate-based immunoassay portfolio and directly manages a team of EIA manufacturing technicians. Reporting to the Director of Manufacturing, this role is the manufacturing department’s primary authority on EIA assay production. The manager is expected to maintain practical command of how each assay works and foster a supportive learning environment for the team. The role also collaborates across the organization to streamline assay manufacturing and develop standardization methods for biological material optimization. The position oversees team development, production scheduling and execution, manufacturing documentation, assay troubleshooting, and continuous improvement. It ensures that EIA output is safe, reliable, within specification and cost targets, and delivered on schedule. The role also champions cGMP/GLP compliance and works with Quality, Supply Chain Planning, Engineering, Product Development, Learning & Development, and Biological Materials teams to address production needs and improve processes.

Requirements

B.S. or M.S. in Biochemistry, Immunology, Molecular Biology, or a related life science field.
At least 5 years of hands-on EIA or comparable assay experience.
At least 3 years in a team lead, supervisory, or management role.
Demonstrated expertise in critical reagent troubleshooting, including conjugation chemistry, buffer formulation, protein aggregation, non-specific binding, and cross-reactivity.
Experience authoring and/or reviewing protocols, SOPs, batch records, and technical reports.
Proficiency in statistical analysis of assay performance data, including precision, accuracy, linearity, sensitivity, specificity, and hook effect.

Nice To Haves

Experience with automated liquid-handling systems in a manufacturing context.
Working knowledge of ERP/MES systems in a manufacturing environment.
Experience in a management role within a regulated manufacturing environment, such as cGMP or ISO 13485.

Responsibilities

Develop EIA Manufacturing Technicians and direct reports through coaching, clear expectations, and timely performance feedback.
Foster the “IMMY Culture” and alignment with organizational values within the EIA team.
Conduct regular one-on-one meetings to identify employee growth opportunities and address performance gaps.
Collaborate with the Learning & Development Team, under the Director of Manufacturing’s direction, to develop training materials.
Provide assay-specific technical training, guidance, and expectations to team members.
Establish and maintain measurable performance metrics for all levels of EIA production.
Create the weekly EIA Manufacturing schedule to meet inventory requirements set by the Master Production Schedule.
Monitor daily schedule adherence and adjust resources to address delays or bottlenecks.
Hold final accountability for meeting the weekly EIA Manufacturing schedule with safe, reliable, in-specification, and within-cost output.
Plan and manage weekly labor assignments, optimize efficiency, and oversee cross-training initiatives.
Ensure facilities, equipment, materials, and staffing are ready to support weekly production output.
Maintain antigen/antibody coating and conjugation schemes and ensure product performance meets validated specifications.
Maintain production records and manage line flow to resolve bottlenecks promptly.
Coordinate with Supply Chain Planning to assess Master Production Schedule feasibility and material availability.
Oversee review and approval of Subassembly and Finished Goods EIA documentation for accuracy, completeness, and timely release.
Advise the Director of Manufacturing about factors affecting product quality; initiate deviation and non-conformance reports and provide corrective-action guidance and options.
Partner with Quality Control and Quality Assurance to manage batch releases and resolve non-conformities.
Serve as the manufacturing department’s primary EIA assay authority, including frontline root cause analysis.
Maintain thorough working knowledge of assay steps and teach them to the team; sustain high-quality, on-time, in-specification production with minimal intervention or deviation.
Review and analyze EIA production data to make timely technical decisions about process adjustments and partner on tools to automate decision-making workflows.
Use data-driven troubleshooting to resolve minor assay and process issues.
Identify recurring EIA manufacturing issues and lead root-cause analysis and solution development, escalating to Process Engineering, Life Cycle Engineering, or Product Development as necessary.
Lead continuous improvement to improve safety, quality, yield, and throughput while reducing waste.
Provide floor-level data, observations, and troubleshooting input to Quality by Design efforts on critical manufacturing parameters.
Identify biological material standardization opportunities and share production data and manufacturing expertise with the Biological Materials team.
Champion cGMP/GLP compliance on the manufacturing floor and participate in internal and external audits.
Collaborate across the organization to improve assay performance across multiple product types, providing EIA technical manufacturing expertise beyond the immediate team.