Specialist Analytical Development
NextPharma GmbH · Livingston, GB, EH53 0TH · United Kingdom · On-site
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We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,300 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working environment with life and spurs our growth. Our winning formula for shared success: room for passion. Because we know that passion is the best medicine when it comes to excellent service around the world. Welcome to NextPharma.
Job Purpose Development Analyst:
To conduct analysis, technical stability studies, and the development, validation and transfer of analytical methods. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment. The successful candidate will thrive in a collaborative, fast-paced environment and play an active role in analytical testing of complex formulations from development through to clinical manufacture.
Key responsibilities and accountabilities:
Actively participate in, and take ownership of, analytical activities to determine the fitness for purpose of finished products ensuring compliance with regulatory and quality standards
Conduct analysis to support formulation development
Perform method development, validation and transfer of analytical methods for liquid filled hard capsules.
Conduct technical stability analysis
Conduct analysis to support product progression through clinical phases
Act as a key point of contact for assigned projects, proactively engaging with clients and internal stakeholders to drive progress, resolve challenges, and ensure successful delivery
Lead the planning, design, execution, and reporting of experimental work, ensuring activities are delivered to a high scientific standard and within agreed timelines
Demonstrate accountability for data interpretation and decision-making, providing clear conclusions and well-justified recommendations to advance projects
Technically competent in analytical activities (e.g., method development and validation, HPLC, GC, Karl Fischer and Dissolution) under current cGMP and ICH Q2.
Take responsibility for the preparation of high-quality client documentation, including development and validation protocols and reports
Checking of analytical data
Provide expert technical support, troubleshooting, root cause analysis, and process optimisation initiatives, ensuring analytical methods are fit for purpose
Contribute to a high-performing team environment by mentoring and developing less experienced colleagues, fostering engagement, knowledge sharing, and continuous improvement
Person Profile: Development Analyst
The ideal candidate will:
Demonstrate resilience and…