To support the site in maintenance of analytical methods for current products, updating and adding new

methods to product specifications e.g. for changes in guidance, supporting re-formulations, API and

excipient changes, leading investigations into product issues, such as dissolution changes, assay

variability. Also including investigation and support of manufacturing changes / issues on site.

To develop and supervise others in the development of suitably rugged physical and chemical analytical

methods that determine all necessary product parameters, including physical characteristics,

determination of active, degradation products, preservatives, and, if necessary, volatiles using the most

suitable analytical instruments available to the company.

Provide supervision, training, technical development and performance evaluation to 2 to 5 direct reports

and other members of staff as appropriate.

To deputise for the ARD manager / team lead as and when required, providing analytical support and

input to other departments across the company, maintaining new product development timelines and

objectives.

Perform periodic and annual reviews for the team.

Ensures validation studies and activities are planned and executed in line with Rosemont SOPs and GMP Requirements and Regulations. Can act as deputy for the validation manager.

Perform the required risk assessments and if necessary, develop and validate suitably rugged Extractable and Leachables and Nitrosamine methods of analysis. Also perform the development and validation of physical and chemical analytical methods that will determine all necessary product parameters including physical characteristics, determination of active, degradation products, preservatives, volatiles using the most suitable analytical instruments available to the company in compliance with standard operating procedures and international scientific, quality and regulatory standards. Provide analytical development support to the business for problem solving and lead continuous improvement projects. Ensure analytical methodology is suitably rugged and fit for its intended purpose. Conduct reviews of emerging technologies, systems, and work practices to support continuous improvement initiatives. Contribute to the development of more efficient and forward-thinking ways of working, to help ensure the company remains at the forefront of technological innovation.

Ensures that company products meet defined quality standards through leadership of product auditing and product release groups. The incumbent oversees review and approval of SOPs, deviation investigations, CAPA management, Change Control management and APRs. Maintains quality systems and works collaboratively with other site functions to drive improvement and enhance quality culture whilst upholding the Rosemont values.

As a member of the Quality Leadership team the post holder will contribute to the creation, execution, review and evaluation of the Functional strategy for their business area. They will additionally feed this insight into our long-range strategic planning process. In collaboration with cross-functional colleagues, they will then ensure the effective implementation and execution of key strategic deliverables.

Working with leadership colleagues, the post holder will drive our purpose and evolve our culture to ensure we sustainably improve the lives of our patients in everything we do every day. They will further role model our values and help ensure Rosemont remains a great place to work.

The Tech Transfer Project Manager leads and directs a variety a programme of work to transfer manufacturing and/ or release testing from third parties to Rosemont facilities.
The role holder will lead stakeholders across all functions to scope, plan, manage risks and deliver projects to support strategic company growth.
The role holder will recommend, align and implement improvements across PMO, whether to drive efficiencies in current programmes or to support the business heading into new directions.

Responsible for leading the cross-functional management of the due diligence team supporting both BD and
M&A initiatives. Will drive projects through from early-stage screening to deal execution, managing timelines,
project planning, risk assessment and reporting.

Independently contribute and/or oversee the required risk assessments and if necessary, develop and validate suitably rugged Extractable and Leachables and Nitrosamine methods of analysis. Also Independently contribute and/or oversee the development and validation of physical and chemical analytical methods that will determine all necessary product parameters including physical characteristics, determination of active, degradation products, preservatives, volatiles using the most suitable analytical instruments available to the company in compliance with standard operating procedures and international scientific, quality and regulatory standards. Provide analytical development support to the business for problem solving and lead continuous improvement projects. Ensure analytical methodology is suitably rugged and fit for its intended purpose. Provide supervision, training, technical development and performance evaluation (periodic and annual reviews) to direct reports and other staff members as appropriate. Independently evaluate emerging technologies, systems, and work methodologies to support the continuous improvement of operational practices. Contribute data-driven insights to inform return-on-investment analyses and enable the adoption of innovative and efficient solutions across the organisation. Deputise for the Manager when required.

Responsible for overseeing the seamless transfer of pharmaceutical products, processes, and technologies from R&D to manufacturing or between manufacturing sites, including from CMOs. This role ensures that all technical, regulatory, operational and quality requirements are met to support successful product launches and lifecycle management.

To liaise with minimal supervision, with 3rd party product developers and 3rd party manufacturers. to successfully technical transfer (TT) to the receiving unit. To provide Support and Technical expertise to the Quality unit to for the transfer of analytical methods. To ensure analytical methodology is suitably rugged and fit for its intended purpose.

To develop the skills and experience necessary to become a competent maintenance and facilities engineer within a pharmaceutical workplace. To support activities that ensure the reliable and safe functioning of all equipment in order to achieve efficient, effective & compliant operations.

To support site facilities activities and the implementation of some capital expenditure projects. To understand pharmaceutical regulations and guidance and appreciate how they are applied throughout all site activities.