Process Development Chemist
- Recruiter
- Anonymous
- Location
- Hitchin
- Salary
- 25000.00 - 35000.00 GBP Annual
- Posted
- 13 Feb 2019
- Closes
- 13 Mar 2019
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
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
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