Specialist Analytical Development

Are you looking for...an exciting professional challengeWe are one of the leading European contract manufacturers in the pharmaceutical biotech and healthcare sectors with some 2500 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 inished productsConduct analysis to support formulation developmentPerform 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 Q2Writing of development and validation protocols and reportsChecking of analytical dataSupporting good internal and external relationships and communicationComply with company health and safety proceduresPerson Profile: Development AnalystPersonality: 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 SituationFlexible and able to work extended hours when required.Specific Job Skills:Required:Relevant qualification HNC/HND/Science Degree or EquivalentAn understanding of drug development and manufacturing processesDemonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standardsMust be skilled in analytical techniques e.g. HPLC Dissolution Gas Chromatography and Karl Fisher techniquesExperience of the technical and practical skills involved stability studies method development transfer and validationAble to communicate well with others both laboratory and non-laboratory basedAble to work with minimal supervision.Good understanding of working within cGMP/GLP environment.Desired:Experience of working within a fast paced pharmaceutical or biotechnology industryMinimum 3 years previous relevant experience in similar environmentAbility to work to key regulatory and compliance requirementsExperience of Chromeleon softwareExperience 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 standardsAble to work with minimal supervision and provide guidance to junior analytical analystsUnderstand 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 we are unable to offer Visa Sponsorship for this role.Its time for your next chapter:We look forward to receiving your application.Required Experience:Unclear Seniority Key Skills Digital Marketing,Bootstrap,Activex,Jboss,Adobe,Arbitration Employment Type : Full Time Experience: years Vacancy: 1