Purpose

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

Key Responsibility Area

• 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 requirements

• 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’s 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 knowledge of organic, organometallic chemistry

• Sound analytical & plant knowledge

• Sound knowledge of cGMP/ GLP

• Knowledge of laboratory safety and hazards

• General Business & Financial awareness

• Good communication skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore 

#Li-GSK 

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.

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.