Nitrosamine - Project Management

About the Company:

NovintiX is a global engineering and digital transformation company with operations across multiple countries that helps leading organizations build innovative products and solve complex business challenges. We work across industries such as Medical Devices, Life Sciences, Healthcare and Manufacturing, delivering engineering, digital, and consulting solutions.

Project Manager – Biotherapeutics Nitrosamine Assessment

Role Summary

The Project Manager will coordinate the initial cross-functional assessment of nitrosamine risk for biotherapeutic products, including proteins and cell and gene therapies. The immediate objective is to determine whether existing paper-based risk assessments and supporting documentation remain adequate against current regulatory expectations, and to define any evidence gaps, potential follow-up work, and an indicative scope and resource estimate.

Key Responsibilities

• Stakeholder coordination: Partner with the designated Biotherapeutics leads to identify and engage the relevant drug substance, drug product, MSAT Material Sciences, and R&D Material Sciences SMEs, keeping outreach focused on the assessment.

• Assessment workplan: Establish a focused workplan with clear owners, milestones, decisions, and dependencies that leads to an initial scope and resource estimate, aligned with the existing Synthetics nitrosamine program.

• Evidence review: Under SME direction, coordinate the review of existing biotherapeutics nitrosamine risk evaluations, underlying assumptions, and supporting evidence, including material, process, water, packaging, and storage inputs.

• Technical discussions: Arrange targeted technical discussions and document decisions, open questions, evidence requests, and follow-up actions. Facilitate comparison of assumed biotherapeutics nitrosamine levels against Synthetics assumptions, and of assumed versus measured Synthetics levels.

• Gap assessment: Track SME conclusions on whether existing paper-based evaluations are sufficient. Where gaps are identified, coordinate definition of any further assessment, testing, or remediation needs, distinguishing between lifecycle management products and products in development.

• Decision-ready reporting: Consolidate agreed findings, open questions, options, indicative scope, timing, and resource needs into a concise, decision-ready update with clear ownership of next steps. Technical conclusions and testing decisions remain with the accountable SMEs.

Required Skills and Experience

• Mandatory: Direct, hands-on experience with nitrosamine risk assessment or related investigations for biotherapeutic products (e.g., proteins, monoclonal antibodies, cell and gene therapies, or antibody–drug conjugates). General biologics experience, or nitrosamine experience limited to Synthetics, does not meet this requirement.

• Project management or coordination experience in a GMP biopharmaceutical environment, including cross-functional document review, action tracking, and evidence-based scope planning.

• Working knowledge of biotherapeutic drug substance and drug product risk factors, nitrosamine assessment documentation, and the distinction between risk evaluation, confirmatory testing, and remediation.

• Demonstrated ability to work effectively with scientific, quality, and regulatory SMEs; translate technical discussions into a clear plan and resource estimate; and manage sensitive scope questions without making scientific or regulatory decisions on their behalf