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 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:
· Relevant qualification, HNC/HND/Science Degree or Equivalent
· 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.
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 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 – we are unable to offer Visa Sponsorship for this role.
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.