Reading, Berkshire, UK
Senior Analytical Chemist
ICE Group is an API and speciality ingredients manufacturer which focuses on the development and manufacture of bile acid derivatives and is one of the main suppliers of UDCA in the world.ICE is a global organisation which has manufacturing facilities in Italy, Brazil, India, Japan, and New Zealand together with R&D facilities in Italy, India, New Zealand, and the United Kingdom.
ICE Group is developing next generation bile acids for possible neurodegenerative (such as Alzheimer’s, Parkinson’s disease) and metabolic disease intervention. These next generation bile acids are developed at ICE UK’s R&D site, located in Shinfield, near Reading under the brand NZP UK. ICE UK is also a leading provider of complex rare oligosaccharides and glycoconjugates and offers bespoke carbohydrate synthesis solutions for biotech and pharma customers under the Dextra brand.
In addition, ICE UK has a GMP manufacturing suite capable of producing active pharmaceutical ingredients for early phase clinical development.
ICE Group is seeking a motivated and experienced Senior Analytical Chemist to join our team. In this role you will be able to apply your experience in an innovative fast paced development environment. It is an exciting opportunity for a proactive scientist to take a leading role in the analysis and characterisation of novel API materials, aiding the development, scale up and transfer of processes for both our inhouse and client projects.
We are looking for an individual with experience in the development and optimisation of methods as well as the performance and co-ordination of forced degradation and method validation studies.
The Analytical team also supports, as required, our catalogue business, stability testing, GMP batch manufacturing and release activities along with analytical method transfers to cGMP contract manufacturing organisations. In addition, this role will include technical mentoring and coaching of other members of the team and maintenance of the analytical equipment.
The ideal candidate will be a self-starter, be able to work collaboratively across multiple functions and provide support and guidance to other team members.
This position is based at the ICE UK facility located on the Thames Valley Science Park, Reading, UK and reports to the Group Leader Analytical Chemistry.
- Ensure all Company health, safety and environmental policy and procedures are adhered to.
- Perform efficient and effective method development/optimisation tasks, method transfers,validations, forced degradation and stability studies, including the preparation of protocols and reports to the required standard, as required.
- Develop testing requirements appropriate for different phases of API development, regulatory approval, and commercialization.
- Work collaboratively with other areas of the business to develop and establish methods specifications, new techniques, recommend alternative approaches and solutions to analytical challenges.
- Provide scientific leadership & technical guidance, training and coaching to other members of the Analytical team.
- Work and engaging with external analytical testing and equipment vendors.
- Ensure that all experimental and analytical data are documented following internal procedures compliant with GMP.
- Conduct regular literature and other searches to maintain an up-to-date knowledge of analytical chemistry, up-to-date regulatory requirements and, current industry trends especially those that relate to bile acids and natural products.
Education & Qualifications
Minimum: BSc/MSc in Analytical, Bioanalytical, Pharmaceutical Sciences or Organic Chemistry with a minimum of 5 years relevant industrial experience in an analytical laboratory performing testing and data analysis/interpretation within the pharmaceutical sector.
- Proven analytical thinking and problem-solving skills
- Ability to work in a fast-paced development environment and meet deadlines
- Able to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business
- Strong interpersonal and communication skills with demonstrated ability to work cross functionally
- Ability to work independently as a subject matter expert for the analytical function
- Motivated team player with a “can do” attitude
- Able to contribute technical expertise to the wider team and provide mentoring and training to other team members
Experience & knowledge
- In-depth knowledge of analytical techniques and methodologies (instrumental and wet chemistry) used in the pharmaceutical sector and demonstration of their practical application in the analysis of in process and final API materials.
- In-depth theoretical knowledge and practical application of method development, validation and troubleshooting of HPLC, UPLC and good practical knowledge of GC, GC-headspace, IC, KF, UV and polarimetry
- Extensive practical experience of analytical data interpretation, good understanding of statistical methods is required
- Knowledge of the ICH, PIC/S & FDA guidelines is required
- Experienced in Technology Transfer of analytical methods is an advantage
- Experienced in raw materials testing, and cleaning verification is an advantage
- Experienced in Mass Spectrometry is an advantage but not required
- Experienced in the application of DoE to optimise analytical assays would also be an advantage
Key Behavioural Attributes – All Staff
- Personal Responsibility
- Customer Focus
Email your CV to [email protected]