Share this Job

Product Development Scientist

Apply now »

Date: Sep 16, 2021

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

Requisition ID:  27882  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

 

 

Terumo BCT Ltd - located in Larne - manufactures a range of sterile pharmaceutical solutions for human use.  A vacancy currently exists for a Product Development Scientist/Engineer within the Innovation and Development group. The successful candidate will be responsible for the development of new parenteral pharmaceutical solutions and support of existing solution products. 

 

(Salary: £Negotiable / dependent upon experience)

 

Duties will include:

  • Leading the development of new solutions: partner with process engineering to development manufacturing process feasibility; determination of specifications for finished goods/stability and analytical test methods; determine acceptance criteria, resolve issues with specifications found during feasibility.
  • Accountable for introduction and evaluation of new analytical methods to analyse raw materials and/or finished products – including drug substance and bag components
  • Leading product development transfer activities
  • Perform statistical analysis and present conclusions to supervisor, project leader and management
  • Support Regulatory Affairs submission packages for a variety of regulatory bodies.
  • Reviews and approve product documentation.
  • Contributes to the establishment of business objectives, goals, budgets and costs
  • Represent Terumo BCT with external customers to identify and decide on feasibility of proposed projects.
  • Translate international standards and local regulatory requirements into product requirements and working to ICH Quality guidelines for Stability and Validation.
  • Participate and/or lead, risk management activities including planning, identification of hazards, analysis and mitigation
  • Adhere to the quality system requirements, local procedures, ensure GMP standards; also, adhere to general and specific environmental, health and safety guidelines.
  • Understanding project timelines, strategy, deliverables and planning project work accordingly with departmental, functional and external stakeholders

 

Essential Criteria:

  • Minimum 3 years' experience gained within the pharmaceutical or medical device industry - similar highly regulated industry will be considered.
  • BSc (or equivalent) in Engineering or Science discipline; or equivalent industrial experience within the medical device or pharmaceutical industry.

 

Desirable Criteria:

  • Experience in analytical techniques (e.g. HPLC, AA, UV, FTIR, ICP-OES and GC etc.)
  • Knowledge of steam and/or other sterilization methods
  • Ability to lead and manage projects Product Technical Transfer experience
  • Experience of method development, validation, verification and transfer, including creation of plans, protocols and reports.
  • Experience in supporting Regulatory Affairs submission packages for a variety of regulatory bodies

 

If you would like to apply for this vacancy, please apply via our internal recruitment website via the link below before the closing date of 5pm Wednesday 29th September 2021    

 

Terumo Blood and Cell Technologies is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.


Job Segment: Product Development, Scientific, Medical, Engineer, Scientist, Research, Engineering, Healthcare, Science