Job 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. This is an assessment-first role; confirmatory testing or remediation
should not be assumed.
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.
Skill Requirements
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