Process Development Chemist

Posted 14 March by Marketplace Group Easy Apply

Pharmaceutical Manufacturer based in Hertfordshire requires an experienced Process Development Chemist to develop new processes which are robust, eco-friendly, economical and suitable for scale-up from gram to kg quantities

Key Duties and Responsibilities:

  • Devising new processes, or refining existing ones, to optimise the manufacturing process;
  • Planning, carrying out and supervising process trials in laboratories, pilot plants or factories;
  • Scaling up the production process via plant trials, making changes to raw materials or components and process parameters to ensure quality is maintained during large-scale production;
  • Improving yields by reducing costs, for example investigating alternative materials or new machinery to improve efficiency and quality in bottle neck areas;
  • Devising test methods to assess the production process;
  • Validating new processes and showing that they are an improvement;
  • Working with product pipelines at various stages of development;
  • Developing formulae, specifications and label declarations, and ensuring compliance with the finished product specifications;
  • Advising on equipment modification to enable process changes for new product development;
  • Reading and writing technical reports and specifications and maintaining appropriate records;
  • Initiating and generating ideas based on reading and research
  • Ability to develop and give presentations on technical topics and train/mentor associates.
  • Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
  • Ability to read, analyse, and interpret complex technical documents and manuals
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to use trends and data to review and improve performance
  • Ensure methods are developed in accordance with current regulatory expectations & are suitable for ASMF submissions. Assemble the basic ASMF as per regulatory requirements
  • Work closely with R&D, Production and QC team to ensure methods are developed and implemented in time to meet project/customer deadlines

Education:

Degree in chemistry

Experience:

Relevant experience within pharmaceutical industry (Minimum 2- 3 years’ experience):

  • Strong knowledge of using HPLC, MS, GC, IR, UV, TLC & Wet chemicaltechniques.
  • Respective method developments and Validation as per ICHrequirements
  • Technology transfer of newly developed methods to pilot scale, both internally and externally
  • Setting specification for raw materials, in-process checks and finishproduct
  • Knowledge of herbal raw materials & API manufacturing will beuseful
  • Writing and reviewingSOP’s
  • Knowledge of current GMP requirements & understanding of Lean/Sixsigma
  • ASMF assembling knowledge

Reference: 34688200

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