EIA Product Line Manager

IMMY•Norman, OK

About The Position

The EIA Product Line Manager leads 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 position requires a deep, practical understanding of each assay and a supportive learning environment for the team. It also collaborates across the organization to streamline assay manufacturing and develop standardization methods for biological material optimization. The role manages team development, performance, training, and production metrics; creates and executes the weekly EIA manufacturing schedule; and ensures safe, reliable, in-spec, and cost-conscious output. It oversees production readiness, labor assignments, line flow, records, product performance, supply-chain coordination, and review and approval of EIA documentation. The Product Line Manager advises on quality concerns, works with QC/QA on batch release and non-conformities, and leads frontline assay troubleshooting and root cause analysis. The position also drives continuous improvement in safety, quality, yield, throughput, and waste reduction; contributes manufacturing data and expertise to Quality by Design and biological-material optimization work; and champions cGMP/GLP compliance, including participation in internal and external audits. The role reports to the Director of Manufacturing.

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 troubleshooting critical reagents, including conjugation chemistry, buffer formulation, protein aggregation, non-specific binding, and cross-reactivity.
Proven 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 IMMY’s culture and values within the EIA team, and conduct regular one-on-one meetings to support employee growth and address performance gaps.
Collaborate with the Learning & Development Team, under the Director of Manufacturing’s direction, to develop technician training materials; provide assay-specific technical training and guidance.
Establish and maintain measurable performance metrics for all levels of EIA production.
Create the weekly EIA Manufacturing schedule to meet inventory requirements established by the Master Production Schedule; monitor adherence and adjust resources to address delays or bottlenecks.
Hold accountability for meeting the weekly schedule with safe, reliable, in-spec, and within-cost output; plan labor assignments and oversee cross-training.
Ensure facilities, equipment, materials, and staffing are ready to support weekly production.
Maintain effective antigen/antibody coating and conjugation schemes and product performance against validated specifications.
Maintain production records and manage daily line flow to resolve bottlenecks.
Coordinate with Supply Chain Planning on 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 guide corrective-action options.
Partner with QC/QA on batch releases and resolution of non-conformities.
Serve as the manufacturing department’s primary EIA assay authority, conducting frontline root cause analysis and maintaining practical command of assay procedures.
Review and analyze production data to make timely technical process decisions and collaborate on tools to automate decision-making workflows.
Use data-driven troubleshooting to resolve minor assay and process issues.
Identify recurring manufacturing issues, lead root-cause and solution work, and escalate to Process Engineering, Life Cycle Engineering, or Product Development when needed.
Champion continuous improvement in 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 opportunities for biological-material standardization and provide production data and expertise to 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.