Job Description

Site Name: Singapore - Jurong
Posted Date: Apr 10 2023

Purpose

1. To plan, organise and carry out experimental work with the objective of:

• Improving existing processes on plant
• Developing and making improvements to processes for new products so as to contribute to the successful introduction of new products/ processes to the plant
• Evaluating raw materials
• Providing troubleshooting support to the operations department

2. Provide technical input to the Secondary interface and ensure that product is fit for purpose 3. Provide support for commissioning and validation on plant 4. Support or lead a team on activities related to process transfers 5. May carry out the role of a Primary Product Owner for API\xe2\x80\x99s under the technical accountability

Key Responsibility Areas

• Ensure process optimisation for a specific product to make improvements to processes with respect to yield, quality, output, cost savings, robustness etc. in line with GMP requirements and ensure suitability for Secondary process performance
• Undertake troubleshooting of problems relating to the plant/ processes to ensure the effective and prompt resolution of issues/ salvage of batch/ development of novel re-work methods for treatment of sub-standard batches
• Ensure proper documentation and filing for a specific product (includes laboratory notebooks, technical memos, analytical raw data, risk assessments, etc.) in compliance with GMP and GLP requirement
• Supervise technicians and junior staff to ensure good and safe work practice.
• Act as a product custodian and ensure the provision of first-line product-specific technical support to its customers (internal and external)
• Provide technical support for routine manufacture and to commissioning teams in the commissioning of established/ new products, as well as conduct training in process chemistry to the relevant parties
• Evaluate the quality of raw materials and intermediates to ensure that it meets company\xe2\x80\x99s specifications, and liaise with external suppliers to provide feedback on the quality of materials
• Contribute to the development of Chemistry, Manufacturing and Control (CMC) plans and strategies for New Chemical Entities (NCEs) Support new product introduction as needed through site impact assessments (SIA) and plant fit evaluations, and participation in technology transfer activities
• Work closely with respective product value streams (e.g. Product Technical Review Teams (PTRT)) to ensure full visibility and alignment of all activities and change/ risk assessments
• Support technical, genotoxic and material risk assessment for change implementation and maintenance of the control strategy throughout product lifecycle
• Support trending and review of key process parameters and attributes as part of Continued Process Verification (CPV)
• Provide technical support for routine process decontamination activities (includes identify process residues, support cleaning risk assessment, cleaning limits calculation, support unknown peak investigation, improvement to current decontamination method, etc)

Skills, Knowledge & Experience

• At least a degree in Chemistry or equivalent
• Experience in a laboratory environment in the pharmaceutical industry or equivalent is desired
• Sound plant, analytical & cGMP/ GLP knowledge
• Knowledge of organic, organometallic chemistry with laboratory safety and hazards
• Financial & General business awareness
• Good communication skill

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
#Li-GSK GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.