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Senior PAT Scientist
Posted 9 hours 22 minutes ago by Femtech Insider Ltd.
Job Description
Organon is hiring a Senior PAT Scientist at our world class manufacturing site in Cramlington, Northumberland.
In this key technical role, you will serve as the site's Process Analytical Technology (PAT) subject matter expert, supporting all drug products manufactured or tested at Cramlington and contributing to Organon's global PAT network.
As part of the Pharmaceutical Technical Operations (PTO) team, you will collaborate with Operations, Quality, and Technical functions to develop, validate, and maintain digital process data, control strategies, and PAT measurement models. Acting as an SME, you will provide broad PAT guidance across drug substance and drug product activities for multiple sites and products.
You will lead and support PAT projects to ensure safe, compliant, on time delivery while driving innovation, process robustness, and continuous improvement. The role includes involvement in process development, investigations, problem solving, and the technology transfer and validation of processes and products. You will also train colleagues in PAT tools and techniques and support the design, installation, and successful operation of new equipment.
Role Responsibilities- Lead and deliver PAT projects, including Proof of Concept activities, ensuring robust implementation across new and existing equipment.
- Act as site PAT subject matter expert, providing strategic technical guidance and mentoring junior specialists.
- Conduct and support complex technical investigations, applying advanced data analytics, DoE, statistical modelling, and multivariate analysis to improve process capability.
- Lead PAT elements of technology transfer and validation, and support the specification, installation, and qualification of PAT instrumentation with Engineering and Operations.
- Ensure compliance with PAT standards, policies, and SOPs, preparing and reviewing documentation and supporting Quality and Compliance initiatives.
- Deliver advanced PAT training programmes, build site capability, and represent the site in global PAT forums to share best practice.
- Drive continuous improvement and operational excellence, enhancing system robustness, supporting lean initiatives, and promoting innovation.
- Apply holistic thinking to ensure all PAT activities meet Safety, Health, Environmental, Financial, and GMP requirements.
- Master's degree in Sciences, Analytical Chemistry, or Chemical Engineering required with applicable experience. PhD preferred with applicable experience.
- Significant experience in pharmaceutical manufacturing, preferably in the use of chemometrics and PAT technologies.
- Proven ability to communicate, influence and work effectively in both individual and cross functional environments.
- Proven Project Management skills for complex projects in a lean manufacturing environment.
- Effective time management and organisation skill to aid prioritisation, resource allocation and meet project deadlines.
- Resilience to demonstrate adaptability and perseverance in the face of challenges.
- Influencing skills to build and maintain relationships by understanding stakeholder requirements, listening, negotiating, using emotional intelligence, adaptability, persistence to build coalitions and drive positive change within the organisation.
- Must be highly flexible and possesses relevant experience in working in an international and multidisciplinary environment and able to support the needs of reliable production and supply.
- Working knowledge of current Good Manufacturing Practices (cGMP) preferred and pharmaceutical production and development technologies.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Recruitment and Position DetailsNumber of Openings: 1
Requisition ID: R539514
Employment Status: Regular
Relocation: Domestic
Femtech Insider Ltd.
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