Contract - Project Manager - Biotherapuetics

Our client is an established engineering consultancy supporting Medical Device, Life Sciences, Pharmaceutical and Biopharmaceutical organizations across the United States.

Their teams provide specialist expertise across Quality Engineering, Manufacturing Engineering, Supply Chain, Project Management, Validation and Regulatory Affairs, supporting both site-based and enterprise-wide programmes.

Typical project activity includes new product introduction (NPI), product development, quality remediation, CAPA, manufacturing improvement, operational readiness, process validation, regulatory compliance and business transformation initiatives.

As a result of increased project demand, they are seeking experienced contractors to support a range of ongoing and newly awarded programmes.

Project Manager - Biotherapeutics Nitrosamine Assessment x 2

Location: East Coast

Duration: 12 months (W2 or C2C considered)

Hybrid - circa 2 days per month (dependent on project need - may increase when required)

Work Authorization for US - no sponsorship offered

About the Role

We are seeking an experienced Project Manager to lead a cross-functional Nitrosamine Risk Assessment programme focused on Biotherapeutic Products, including proteins, monoclonal antibodies, and cell & gene therapies.

This role will be responsible for coordinating the initial assessment of existing nitrosamine risk evaluations and supporting documentation to determine alignment with current regulatory expectations.

The focus of the assignment is on assessment, gap identification and planning, rather than confirmatory testing or remediation activities.

Working closely with Scientific, R&D, Quality and Regulatory teams, the successful candidate will facilitate technical reviews, stakeholder alignment and decision-making processes to establish scope, resource requirements and recommended next steps.

Key Responsibilities

• Coordinate cross-functional stakeholders across Drug Substance, Drug Product, Material Sciences, R&D, Regulatory Affairs and Quality functions.


• Develop and manage a structured assessment workplan including milestones, deliverables, dependencies and resource requirements.


• Facilitate the review of existing biotherapeutics nitrosamine risk assessments and supporting documentation.


• Coordinate technical discussions, capture decisions, actions and evidence requirements.


• Support comparison of current biotherapeutics risk assessment approaches against established synthetic product methodologies where appropriate.


• Track identified gaps and coordinate definition of follow-on assessment, testing or remediation requirements.


• Differentiate requirements across both commercial lifecycle products and products currently in development.


• Consolidate findings into clear, decision-ready reports for programme stakeholders.


• Ensure alignment of activities with corporate risk management and regulatory compliance expectations.

Required Experience

• Direct experience supporting Nitrosamine Risk Assessments relating to Biotherapeutic Products.


• Experience within Biopharmaceutical, Biotechnology or Life Sciences environments operating under GMP requirements.


• Proven project management experience coordinating complex, cross-functional scientific or technical programmes.


• Understanding of Biotherapeutic Drug Substance and Drug Product development, manufacturing processes and associated risk considerations.


• Experience reviewing risk assessments, technical documentation and scientific evidence packages.


• Ability to translate complex scientific discussions into clear project plans, timelines and resource estimates.


• Strong stakeholder management, communication and reporting skills.

Essential Requirement

Applications will only be considered from candidates with direct experience of nitrosamine assessments within biotherapeutic products, including proteins, monoclonal antibodies, cell and gene therapies, or antibody-drug conjugates (ADCs).

Candidates whose nitrosamine experience is limited solely to synthetic pharmaceutical products will not be considered for this assignment.

Interested in learning more?

To apply or discuss this opportunity in further detail, please contact Jidz Khan at Redline Group on +1 737-285-0256 or jkhan@redlinegroup.Com , quoting the relevant reference number.

We look forward to hearing from you.