Senior Technical Manager

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

Other Requirements