Sr. R&D Formulation Scientist/ Manager Development & Design of Medicinal Products Sr Product Development Specialist/ Sr Product Development Scientist

Our Client: R&D Experimental and Analytical Labs based in Sofia, Bulgaria. The company delivers its customer tailored services internationally and provides full supply chain solutions through its exclusive manufacturing partners.

 

Overall objective:          

Pharmaceutical SOD forms formulation/development

Responsibilities:

  • Initiates/generates ideas for product formulation/development based on research and/or pharmacopeia monographs for all available API(s) and final product(s)
  • Evaluates/examines existing/available API(s) for initiated product developments based on physicochemical and biological properties (i.e. solubility, water content, particle size, crystal properties, biological activity and permeability, etc) and the interrelation of these properties that can influence the performance of the drug product and its manufacturability. Based on the results/outcomes, recommends potential suppliers for initiated product developments.
  • Carries out a series of formulation experiments with an ability to correlate the analytical results for sequencing trials to determine the target composition(s)
  • Monitors closely the analytical testing results to achieve the desired target product specification and optimum formulation composition
  • If needed, initiates changes to raw materials or components, and/or process parameters to ensure designed quality can be maintained during large-scale production
  • Evaluates the appropriateness of the manufacturing and laboratory equipment
  • Devises new processes, or refine existing ones, to optimise the manufacturing process
  • Reports and summarizes results of experimental trials and other data into a format that allows easy review and decision making
  • Participates in scale-up transfers and validation activities to manufacturing site
  • Supports the manufacture of experimental pilot and registration batches
  • Key stakeholder in communication with CROs, agreeing clinical study design protocols
  • Prepares technical reports and specifications and maintains appropriate records
  • Advises on product registration strategy based on product specification, intended usage, route of administration and applicable regulatory requirements
  • Participates actively in preparation of Pharmaceutical Development module of the product dossier
  • Replies to questions raised by Regulatory Authorities during dossier assessment process

Education and Experience:

  • Master Degree in Chemistry/Pharmacy
  • 3-5 years experience within the area of pharmaceutical SOD product development
  • R&D lab/pilot scale feasibility trials
  • R&D Lab and Production equipment handling
  • Reading and understanding statistics, data and results generated by analytical laboratory and in-process control
  • Raw Materials Evaluation (APIs, excipients, and packaging materials)
  • Technical transfers
  • Good understanding and knowledge of Quality Systems and cGMP requirements for pharmaceutical industry
  • Good understanding and knowledge of ICH guideline Q8 (R2) on pharmaceutical development
  • Good understanding and knowledge of EU Regulatory requirements

Skills:

  • Highly organized and able to work independently on multiple tasks in a fast-paced environment
  • Entrepreneurial/creative/scientific approach to problem solving and project opportunities
  • Ability to multitask and work to demanding and changing schedules and priorities
  • Cross-functional team collaboration
  • Excellent verbal/written communication
  • MW, Excel, PowerPoint

 

Please send your CV to email: taurus@taurusconsultants.bg

Your data will be treated with respect and confidentiality in accordance with GDPR.