EIA Product Line Manager

Description

Job Purpose

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 serves as the manufacturing department's primary authority on EIA assay production.

Expectations include maintaining a deep, practical understanding of how each assay works and fostering a supportive learning environment for the team. Strong performance in this role creates opportunities to collaborate with teams across the organization to streamline assay manufacturing and develop standardization methods for biological material optimization.

Key Duties and Responsibilities

Lead, Manage, and Accountability (LMA)

• Team Development: Develop EIA Manufacturing Technicians and direct reports through supportive coaching, clear expectations, and timely performance feedback.
• Culture & Values: Foster the “IMMY Culture” within the EIA team, ensuring alignment with core organizational values.
• 1-on-1s: Conduct regular 1-on-1 meetings to identify employee growth opportunities and address performance gaps.
• Training Materials: Collaborate under the direction of the Director of Manufacturing with the Learning & Development Team to develop training materials for EIA Manufacturing Technicians.
• Technical Guidance: Provide technically sound, assay-specific training, guidance, and expectations for team members.
• Performance Metrics: Establish and maintain measurable performance metrics for all levels of EIA production.

Deliver & Execute the EIA Production Schedule

• Scheduling: Create the weekly EIA Manufacturing schedule to meet inventory requirements set by the Master Production Schedule.
• Adherence & Adjustments: Monitor daily schedule adherence and adjust resources as needed to compensate for delays or bottlenecks.
• Accountability: Hold final accountability for meeting the weekly EIA Manufacturing schedule with safe, reliable, in-spec, and within-cost output.
• Labor Management: Plan and manage weekly labor assignments to optimize efficiency and oversee cross-training initiatives to build team resilience.
• Readiness: Proactively ensure facilities, equipment, required materials, and adequate staffing are ready and capable of supporting weekly output.
• Product Performance: Maintain sound antigen/antibody coating and conjugation schemes, ensuring an excellent record of product performance against validated specifications.
• Record-Keeping & Line Flow: Maintain exceptional record-keeping across all EIA production activities and manage line flow throughout the day to resolve bottlenecks quickly.
• Supply Chain Coordination: Liaise with the Supply Chain Planning team to ensure the feasibility of the Master Production Schedule and material availability.

Oversee EIA Manufacturing Documentation

• Document Review: Oversee the review and approval of Subassembly (SA) and Finished Goods (FG) EIA documentation to ensure accuracy, completeness, and timely release.
• Quality Escalation: Advise the Director of Manufacturing on factors affecting product quality; initiate deviation and non-conformance reports, providing guidance and options for corrective actions.
• Cross-Functional Quality Alignment: Partner with Quality (QC/QA) to manage batch releases and resolve non-conformities.

Serve as Frontline Manufacturing Authority on EIA Assays

• Root Cause Analysis: Serve as the manufacturing department's primary authority on EIA assays, including frontline root cause analysis.
• Assay Mastery: Maintain a secure command of EIA knowledge; understand all steps of the assays on the bench and teach with equal rigor. (Mastery is demonstrated by sustainably delivering high-quality product on time, in specification, with minimal intervention or deviation).
• Data Decisioning & Automation: Review and analyze EIA production data to make timely technical decisions on process adjustments, and partner in developing tools to automate decision-making workflows.
• Data-Driven Troubleshooting: Apply a data-driven troubleshooting paradigm to resolve minor assay and process issues.

Drive Manufacturing Problem-Solving & Continuous Improvement

• Issue Escalation & Resolution: Identify recurring EIA manufacturing issues and lead the team in finding root causes and solutions—escalating to Process Engineering, Life Cycle Engineering, or Product Development as necessary.
• Process Improvement: Champion continuous improvement on the team to improve safety, quality, yield, and throughput while reducing waste.
• Quality by Design (QbD) Support: Provide floor-level data, observations, and troubleshooting input to Life Cycle Engineering's and Process Engineering's Quality by Design efforts on critical manufacturing parameters (e.g., coating concentration, blocking agent selection, detection chemistry, signal amplification, wash conditions).
• Material Optimization: Flag opportunities for biological material standardization to the Biological Materials team, providing production data and floor expertise to support optimization.

cGMP/GLP Compliance & Collaboration

• Compliance Champion: Champion cGMP/GLP compliance on the manufacturing floor and enthusiastically participate in both internal and external audits.
• Cross-Functional Technical Expertise: Collaborate with teams across the organization to improve assay performance across multiple product types, extending EIA technical manufacturing expertise beyond the immediate team.

Qualifications

Required Qualifications

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

Desired Qualifications

• 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 (cGMP, ISO 13485).

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.