Specialist Analytical Development

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an exciting professional challenge

We are one of the leading European contract manufacturers in the pharmaceutical biotech and healthcare sectors with some 2300 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:

1. 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
2. • 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
3. 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
4. Lead the planning design execution and reporting of experimental work ensuring activities are delivered to a high scientific standard and within agreed timelines
5. Demonstrate accountability for data interpretation and decision-making providing clear conclusions and well-justified recommendations to advance projects
6. Technically competent in analytical activities (e.g. method development and validation HPLC GC Karl Fischer and Dissolution) under current cGMP and ICH Q2.
7. Take responsibility for the preparation of high-quality client documentation including development and validation protocols and reports
8. Checking of analytical data
9. Provide expert technical support troubleshooting root cause analysis and process optimisation initiatives ensuring analytical methods are fit for purpose
10. 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 composure thriving under pressure and embracing challenges with a proactive solutions-focused mindset
• Act with integrity and accountability confidently communicating facts in a clear and constructive manner building trust with colleagues and clients and taking ownership of decisions and outcomes including learning from mistakes
• Exhibit sound judgement and decision-making drawing on data experience and insight to make timely well-informed choices that move projects forward
• Take ownership of priorities driving focus on what matters most effectively managing time and resources while removing barriers to progress and maintaining project momentum
• Apply strong analytical thinking and structured problem-solving skills using data-driven approaches to overcome complex challenges and deliver effective practical solutions
• Embrace continuous improvement actively seeking opportunities to enhance processes ways of working and technical approaches
• Demonstrate a growth mindset showing curiosity openness to feedback and a commitment to ongoing personal and professional development
• Thrive in a dynamic collaborative and energised team environment contributing positively to team culture and bringing enthusiasm to shared goals

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

• Relevant qualification HNC/HND/Science Degree or Equivalent in Pharmaceutical Sciences Chemistry or a related discipline
• An understanding of drug development and manufacturing processes
• Demonstrated technical competence in the technical and practical skills involved in analytical activities to prescribed quality standards
• Must be skilled in analytical techniques e.g. HPLC Dissolution Gas Chromatography and Karl Fischer techniques
• Experience of the technical and practical skills involved in stability studies method development transfer and validation
• Able to communicate well with other colleagues both laboratory and non-laboratory based
• A self-motivated and proactive approach with the ability to work independently while taking ownership of deliverables
• Good understanding of working within a cGMP/GLP environment.

Desired:

• Experience of working within a fast paced pharmaceutical or biotechnology industry
• Minimum 3 years previous relevant experience in similar environment
• Ability to work to key regulatory and compliance requirements
• Experience of Chromeleon software
• Experience of chemical analysis within a pharmaceutical environment (with drug products for preclinical and clinical trials).
• Experience of data reporting and data checking to GMP standards
• Able to work with minimal supervision and provide guidance to junior analysts
• Understand and demonstrate a pragmatic approach to problem solving within GMP constraints
• Able to communicate well via written media with specific emphasis on report writing

Digital & Data Skills: Proficient in MS Office and modern digital tools with the ability to analyse manage and present data effectively

Technical Writing & Data Interpretation: Strong scientific writing skills with the ability to interpret and clearly communicate analytical and experimental data

Communication & Stakeholder Engagement: Confident communicator able to engage effectively with clients and cross-functional teams across multiple formats

Leadership & People Development: Ability to lead coach and mentor others while contributing to a collaborative high-performing team environment

Please note only applicants with a permanent Right to Work in the UK will be considered

Remuneration Package:

Basic Salary: DOE

Private Medical Insurance

Health Cash Plan

Contributory pension scheme

Life Insurance

NextPharma is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex race disability age sexual orientation marriage or civil partnership pregnancy or maternity religion or belief.

Its time for your next chapter:

We look forward to receiving your application.

Required Experience:

IC

Employment Type : Full Time
Experience: years
Vacancy: 1