Particle Engineer (Chemical Engineering) / Milling Specialist

Location: Dudley, Northumberland, UKDepartment: Research and DevelopmentReference: VN039
Summary of Particle Engineer role

We have an exciting new specialist opportunity for a Particle Engineer to join our research and development team based in Dudley, North East England. The successful candidate will provide technical and team leadership for the development of pre-formulation particle engineering steps for Active Pharmaceutical Ingredients (APIs) in our new state of the art milling suites. These suites are the focal point of the Material Science Centre. Running throughout the three floors of the facility, the mills are housed in International Organization for Standardization (ISO) class 8 cleanrooms with controlled access and video monitoring to enable customers to view inside the mill during operation.

The Particle Engineer is a specialised position, and the successful candidate will be considered a subject matter expert in powder and particle-technology operations, development, trials, scale up and manufacturing. In addition they will be able to plan and lead the development and implementation of particle engineering solutions for development and clinical scale-up batches of new drug substances, designing processes to deliver specified quantity, quality, and budget and also communicate proposals with customers, assist in the selling of the service provision and driving innovation and new technology opportunities.


Responsibilities
 
  • Develop and optimise the execution of milling and particle size development experiments, carrying out milling development as well as current good manufacturing practise (cGMP) milling operations so that definitive conclusions are made, and deliverables are met. Work will involve both development as well as oversight and collaborative work with chemists, plant and quality personnel.
  • Performs milling and particle engineering process development and processing in accordance with Sterling policies and practices with respect to GMP, environmental, health, and safety (EHS) and other related regulatory requirements.
  • Maintains up to date awareness of the latest developments in particle engineering and allied areas through literature review, conferences, vendor discussions and related activities.
  • Design and carry out complex research projects so that definitive scientific conclusions are reached. Seek out and test valid explanations for all results.
  • Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer-reviewed manuscripts.
  • Builds capabilities in and integration of PAT, process modelling, scale up calculations, Quality by Design (QbD) and other related activities.
  • Ensure cGMP/GLP compliance
  • Embody our company values, which are: be reliable, be caring, be transparent and be willing.

Key Skills and Competencies
 
  • Minimum of B.S. in Chemical Engineering or related scientific discipline; M.S. or Ph.D. a plus.
  • 5+ years of relevant industry experience.
  • Knowledge of chemical engineering principles and experience in process scale up.
  • Experience managing development projects or capital projects with various priorities, deadlines, user requirements and technical challenges.
  • Basic knowledge of analytical techniques.
  • Ability to define problems, collect data, recognise patterns, and draw valid conclusions and deal with both abstract and concrete variables
  • Experience in data processing and manipulation.
  • Extensive knowledge of pre-formulation particle engineering and associated cGMP requirements in a pharmaceutical environment
  • A particle engineer expert who, along with having significant project responsibility, will provide technical input in the area of material science during the processing of APIs

You will receive

A competitive salary, pension scheme, Perkbox, healthcare, 25 days annual leave, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme. Training and opportunities for further career development.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.
Service. Passion. Science.