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.....Read more...
Our client is an established engineering consultancy supporting Medical Device, Life Sciences, Pharmaceutical and Biopharmaceutical organisations 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.
Manufacturing Engineer - Casting & Mold Flow Qualification
Location: Massachusetts
Duration: 12 months (W2 or C2C considered)
Hybrid – circa 2 days per month (dependent on project need – may increase when required)
Work Authorisation for US – no sponsorship offered
About the Role
We are seeking an experienced Manufacturing Engineer to support investment casting, process qualification and manufacturing validation activities for orthopedic medical device components. The successful candidate will play a key role in casting process development, mold flow analysis, tooling optimisation, process validation and continuous improvement initiatives within a regulated manufacturing environment.
Key Responsibilities
Support investment casting operations, including wax pattern creation, shell building, casting, finishing and inspection activities.
Develop, optimise and qualify casting processes, operating parameters and manufacturing work instructions.
Troubleshoot casting defects, including porosity, shrinkage, inclusions, dimensional variation and yield loss.
Perform dimensional analysis, process capability studies and statistical analysis using tools such as Minitab.
Drive process improvements through DOE, SPC, Lean Manufacturing and Six Sigma methodologies.
Conduct casting simulation and mold-flow analysis using ProCAST, MAGMASOFT or similar software.
Correlate simulation data with production results to optimise tooling, gating, risers and manufacturing processes.
Support IQ, OQ and PQ activities, including validation protocols, process characterisation and final reports.
Work with suppliers on tooling development, process improvement and technical assessments.
Support NPI, design transfer, manufacturing scale-up and engineering change activities.
Participate in PFMEA, control plans, risk assessments, CAPA investigations and root cause analysis.
Ensure compliance with FDA, ISO 13485, GMP and medical device quality requirements.
Required Experience
Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Materials Engineering or a related discipline.
Proven experience within Manufacturing Engineering, Process Engineering or Foundry Operations.
Strong investment casting, casting process development or foundry experience.
Experience with casting simulation and mold-flow analysis software such as ProCAST or MAGMASOFT.
Knowledge of process qualification, validation and IQ/OQ/PQ methodologies.
Proficiency in DOE, SPC, Cp/Cpk, statistical analysis and Minitab.
Experience with CMM, GD&T, dimensional inspection and CTQ analysis.
Knowledge of PFMEA, CAPA, process controls and root cause analysis.
Experience working within a regulated manufacturing environment.
Strong technical writing, problem-solving and stakeholder management skills.
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.
....Read more...
Co-Founder & CTO – AI Startup – USA Remote (Artificial Intelligence, LLMs, RAG, AI Agents, Python, Cloud Architecture, Data Engineering, Cybersecurity, SaaS, Technical Leadership) Build something that matters. Own the technology. Shape the future of AI. This is a rare opportunity for an ambitious technology leader to join an exciting AI venture as Co-Founder & Chief Technology Officer, taking the reins of a platform with the potential to redefine how businesses understand and navigate the world of luxury, wealth and ultra-high-net-worth individuals. The business is building a next-generation intelligence platform that combines proprietary data, real-time insights and advanced AI to uncover opportunities that traditional research and analytics simply cannot. With a working product and initial funding already secured, the foundations are in place. Now, the business needs an exceptional technical mind to take it to the next level. This isn't a traditional CTO role where you'll inherit an established team and spend your days managing roadmaps. You'll have the freedom and responsibility to shape the entire technology function, make the big architectural decisions, build your own engineering team and turn an ambitious vision into a market-leading product. With meaningful founder equity on the table, you'll have a genuine stake in what you help create. We're looking for someone who can combine technical brilliance with a founder's mindset. You'll bring: • A proven track record of building and deploying sophisticated AI systems in production, including LLMs, RAG pipelines, AI agents and robust model evaluation.• The architectural expertise to create secure, scalable, enterprise-grade platforms that customers can trust with their most valuable data.• Strong hands-on engineering skills, with the ability to write and review code while setting the technical direction for the business.• Deep knowledge of data infrastructure, retrieval systems, cloud architecture and the practical economics of operating AI at scale.• The vision and leadership to recruit a talented founding engineering team and create an environment where exceptional engineers can do their best work.• The entrepreneurial drive to move quickly, challenge conventional thinking and take full ownership of the technology behind the business. Experience in vertical AI, enterprise intelligence, financial data or other complex data-driven environments would be a significant advantage. You don't need a background in luxury; you need the technical ability and ambition to build something exceptional. What makes this opportunity different? • Real founder-level influence: Define the architecture, product roadmap and engineering culture from day one.• A product that's already taking shape: Build on an existing platform rather than starting with a blank page.• A genuinely exciting AI challenge: Bring together proprietary intelligence, advanced AI and predictive capabilities in a highly specialised market.• The chance to build your own team: Recruit and lead the engineers who will help turn the vision into reality.• Meaningful equity: Share in the value you help create as the business grows.• Freedom to make an impact: Work directly with the founding team, with the autonomy to make critical decisions and see them through. In your first six months, you'll take ownership of the architecture, strengthen security and reliability, build out the engineering team and prepare the platform for enterprise customers. From there, you'll help expand the product's capabilities, deepen its proprietary data advantage and establish the technical foundations for the company's next stage of growth. The details • Location: USA – fully remote• Salary: $195,000• Equity: Meaningful founder equity If you're an AI leader who wants more than another CTO title — someone who wants to build, lead and own a meaningful part of an ambitious technology business — this is an opportunity worth exploring. Further details will be shared with shortlisted candidates under a confidentiality agreement. Noir continues to be a leading technology recruitment specialist; we can help you make the right career decisions!
NOIRUSATECHREC NOIRUSAREC....Read more...
