Process Development Chemist
GSK Singapore Full-time
Site Name: Singapore - Jurong
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
Posted Date: Mar 20 2025
Purpose
The R&D Senior/Process Development Chemist is responsible for the introduction of new chemistry from R&D API chemistry for the production of drug substance for use in clinical, toxicology and safety trials. He/she is also responsible for the commercial evaluation of processes to identify scale-up issues and DFM opportunities.The Senior/Process Development Chemist is also involved in the technical transfer of a new product from R&D into the manufacturing site.
Responsibilities- Liaise with the R&D Project team to stay up to date with process development and to assess the process for its ease of operation.
- To design process.
- Propose alternative operational strategies where appropriate.
- Liaise with the R&D process engineers and agree with the scale of operation and suitable plant and equipment in which to run the process. Evaluate the process in detail with the process engineer to ensure that any engineering requirements are incorporated into the Batch Record.
- Liaise with the R&D project team / and the pilot plant team to plan the campaign, including the number and scale of batches for each stage, length of campaign, equipment / labour requirements etc to ensure that supply request is made on time.
- Liaise with the process safety scientist / process engineer to ensure that all safety issues are satisfactorily addressed.
- Liaise with the API chemists and procurement to ensure that sufficient materials of the correct quality are purchased and are available by the processing date.
- Liaise with the NPI Project Manager in Technical Development to ensure key manufacturing requirements are met.
- Write the Batch Record documents ensuring that the requirements of the API chemists, process engineers, process safety scientist, cGMP and project leader are all accommodated.
- Provide technical cover (running in-process checks and controls as required) during the processing period.
- Provide process chemistry training and other relevant trainings for Pilot Plant team.
- Assessing any process deviations. Initiate, participate or lead investigations when appropriate.
- Writing a post campaign report, post Qualification campaign report covering key batch data and any process recommendations for the validation campaign.
- Co-ordination and execution of the post campaign review meeting.
- Collating data for hand-over of process to manufacturing.
- Reviewing the process and recommending any changes required based on plant experience to API chemists / process safety scientist / process engineers / project leader and incorporating these into a new issue of the Batch Record.
- Critical review of chemistry and process design.
- Liaise with Technical Development & capital project engineers regarding commercialisation, production facility requirements.
- HAZOP's.
- Prepare documentation for validation campaign (Batch Sheets, PQ Protocol, SOP's, process team training package etc).
- Training of relevant process team members on the process.
- Support the commercial start-up (as per validation campaign).
- Support PAI/FDA inspections.
Skills, Knowledge & Experience
Professional:
- At least a degree in Chemistry or equivalent
- Some experience in a laboratory environment in the pharmaceutical industry or equivalent is desired
Technical:
- Sound knowledge of organic, organometallic chemistry
- Sound analytical knowledge
- Sound plant knowledge
- Sound knowledge of cGMP/GLP
- Knowledge of laboratory safety and hazards
Competencies:
- Interpersonal skills
- Influencing skills
- Planning and organization skills
- Problem solving skills
- Strategic thinking skills
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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