Pharmaceutical Development Analytical Scientist 12-month FTC

at  Norgine

Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that is your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting opportunity for an Analytical Scientist to join Norgine in the Pharmaceutical Development department. The person holding this position will report to a Senior Group Leader and be a member of the Global Development team.
The core responsibility of the role is to contribute to the development and introduction of new products and line extensions into Norgine’s portfolio.

REQUIREMENTS

• Provide analytical expertise to PD and to Norgine including but not limited to analysis of finished products, raw materials, in-process control (IPC) samples, and stability studies.
• Work in compliance with GxP, Company Procedures, and pharmaceutical industry guidelines and standards, including but not limited to ICH, USP, Ph.
• Eur., JP, ISO, MHRA, FDA, PMDA regulations. Ensure that all work and working practices are carried out to the appropriate quality standard.
• Work independently with minimal guidance, prioritising own workload and coordinating with other team members to provide effective analytical resource.
• Participate in cross-functional analytical teams comprising internal and external
• stakeholders, communicating effectively at all levels to deliver analytical projects.
• Manage and deliver analytical work packages, raising and ensuring the appropriate documentation is in place, co-ordinating activities both internally and externally to ensure all timelines and budgetary requirements are met.
• Write and review analytical validation and transfer protocols, reports, and
• methods, and maintain other technical documentation including laboratory notebooks in line with Standard Operating Procedures.
• Plan and execute stability studies, writing protocols, performing analysis, and reporting results, in line with Standard Operating Procedures.
• Author-relevant Chemistry and Manufacturing Control (CMC) sections that contribute to the compilation of dossiers.
• Use knowledge of best practices to resolve complex problems and to suggest and contribute to process improvements.
• Maintain an awareness of budgetary requirements to assist in maintaining departmental spending within budget.
• Use in-depth knowledge to provide formal training and informal guidance to personnel internally and externally in a variety of processes, techniques and disciplines as required, acting as a resource for colleagues with less experience.
• Responsible for validation activities to ensure the expedient introduction of new equipment into PD and Norgine as required.
• Manage external contractors, co-ordinating activities and ensuring service delivery.

A DEGREE OR EQUIVALENT QUALIFICATION IN A SCIENTIFIC DISCIPLINE IS ESSENTIAL.

Technical Knowledge:

• Experience in chromatography and general wet chemistry techniques.
• Experience in analytical method development, validation, and transfer.
• Proven experience within the pharmaceutical industry.
• Understanding of GxP, ICH guidelines, Pharmacopeias, and relevant regulatory requirements.
• Accomplished data analysis skills.
• Computer literate.

Communication:

• Strong written and oral communication skills, capable of communicating technical data and information at all levels in a clear, concise, and professional manner.
• Proven experience with data integrity requirements in a GxP environment.

Personal Management:

• Co-operates with others, working together, sharing objectives, and delivering goals as part of a team.
• Highly motivated and maintains the ability to work independently.
• Ability to prioritise workload dependent upon objectives and business needs, and a willingness to adapt to changing priorities and deadlines.

• Manage, perform and report analytical activities within PD ensuring that data integrity is maintained throughout the process.
• Develop, validate, and transfer analytical methods to support Pharmaceutical Development and Norgine activities in compliance with GxP, Company Procedures, and industry guidelines and standards.
• Ensure that laboratory equipment and facilities within the NDC are validated, calibrated and maintained in accordance with Company Procedures and quality standards.
• Set up and perform stability studies on new formulations and existing product variations.
• Responsible for ensuring cGMP compliance is maintained within the NDC laboratory and analytical service providers.
• Provide subject matter expertise in audits from internal and external bodies when required.
• Engage with internal and external partners to plan and deliver analytical projects.
• Provide support to due diligence activities with appropriate analytical chemistry subject matter expertise.
• Support the supply of IMP in accordance with cGxP.