Specialist Analytical Development

NextPharma Technologies Holding Ltd; Livingston; On-site; GBP 35,000 - 45,000; Full time

Job summary

A leading European pharmaceutical company is seeking a Development Analyst to conduct analyses and technical stability studies, along with the development, validation, and transfer of analytical methods. The ideal candidate will have a strong analytical background with at least 3 years of experience in a cGMP regulated environment. Key responsibilities include performing analytical activities, writing reports, and ensuring compliance with health and safety procedures. Join our dynamic team in Livingston, Scotland.

Qualifications

• Minimum 3 years relevant experience in a similar environment.
• Good understanding of working within cGMP/GLP environment.
• Ability to work to key regulatory and compliance requirements.

Responsibilities

• Conduct analysis to support formulation development.
• Perform method development, validation, and transfer of analytical methods.
• Write development and validation protocols and reports.

Skills

HPLC

Gas Chromatography

Karl Fisher techniques

Data reporting

Problem solving

Tools

Chromeleon software

MS Office

Job description

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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, 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.

Key responsibilities and accountabilities

• Work as part of a team alongside other analytical departments.
• Actively involved in performing analytical activities to determine fitness for purpose of finished products
• Conduct analysis to support formulation development
• Perform method development, validation and transfer analysis of analytical methods for Liquid Fill hard capsules.
• Technically competent in analytical activities (e.g., method development and validation, HPLC, GC, Karl Fisher and Dissolution) Validation activities performed under current cGMP and ICH Q2
• Writing of development and validation, protocols and reports
• Checking of analytical data
• Supporting good internal and external relationships and communication
• Comply with company health and safety procedures

Person Profile: Development Analyst

Personality

Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability; Reliable, tolerant and dependable: Enjoy working in a stimulating environment. Comfortable dealing with peers and customers. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player, but is equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills

Required:

• An understanding of drug development and manufacturing processes
• Demonstrated technical competence of 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 Fisher techniques
• Experience of the technical and practical skills involved stability studies, method development, transfer and validation
• Able to communicate well with others, both laboratory and non-laboratory based
• Able to work with minimal supervision.
• Good understanding of working within cGMP/GLP environment.
• 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 formulations of drug products for pre-clinical and clinical trials).
• Experience of data reporting and data checking to GMP standards
• Able to work with minimal supervision and provide guidance to junior analytical analysts
• Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.
• Able to communicate well via written media with specific empehsis on report writing.

Computer skills

Must be competent in the use of MS Office, particularly Excel and Word,
e-mail and internet.

Literacy and Numeracy

Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.

Business Presentation Skills

Must be an excellent face-to-face and telephone communicator.

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

It’s time for your next chapter

We look forward to receiving your application.