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
Degree in chemistry
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