Technical Project Manager

Description

Role Overview

Reporting to the Lead Project Manager, this role is responsible for the day-to-day project management of molecular (PCR-based) and immunoassay-based IVD product development and transfer projects. The Technical Project Manager will be embedded in the technical process, working closely with PD scientists, Design Assurance, Quality, Regulatory, and other functions. You will drive projects through IMMY's defined transfer process from development through to commercial readiness.

Key Duties & Responsibilities

Project Execution

• Manage Ownership: Lead 2–3 active projects simultaneously through all phases—from early planning and cross-department communication to launch readiness.
• Planning: Develop and maintain detailed project plans, timelines, and action logs.
• Monitoring: Track progress against milestones and escalate risks or blockers to the Lead Project Manager in a timely manner.
  
  

Transfer Process Management

• Facilitation: Arrange and lead early-stage planning and technology transfer meetings with key stakeholders.
• Technical Oversight: Ask critical questions to ensure technical, quality, and regulatory requirements are addressed throughout the project lifecycle.
• Compliance: Ensure all design, development, and transfer activities align with IMMY’s defined processes and SOPs.
• Phase Gate Reviews: Support review meetings by preparing agendas, collating documentation, taking minutes, and tracking follow-up actions.
• Documentation: Ensure all design control and project documentation meets the required standards for quality and regulatory compliance.
  
  

Stakeholder Coordination

• Primary Contact: Act as the main point of communication for project-specific development team members.
• Technical Liaison: Work closely with technical teams to translate progress and challenges into actionable project reporting.
• Reporting: Feed project-level updates into the Lead Project Manager’s portfolio oversight.
  
  

Qualifications

Required Education & Experience

• Degree: Bachelor’s degree in a relevant life science discipline (e.g., Biochemistry, Immunology, Biomedical Science); Postgraduate qualification is desirable.
• Experience: Minimum 3–5 years in project management or coordination within an IVD, diagnostics, or life sciences environment.
• Technical Expertise: Hands-on experience with immunoassay and molecular assay product development (e.g., Lateral Flow, ELISA, Chemiluminescence, qPCR) is strongly preferred.
  
  

Skills & Knowledge

• Regulatory Standards: Knowledge of IVD quality systems including ISO 13485, FDA 21 CFR Part 820, and IVDR is a plus.
• Versatility: Experience across both immunoassay and molecular diagnostics (PCR) is a distinct advantage.
• Organization: Highly organized with the ability to manage multiple high-priority tasks simultaneously.
• Communication: Strong written and verbal skills; confident in facilitating meetings and producing clear technical documentation.
• Tools: Proficient in Microsoft Office / 365 and modern project management software.
  
  

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.