Job Description

Companies which manufacture products typically need development Scientist who understand and control the processes used to make the final product.

The Process Science & Manufacturing Technology function contributes to the Manufacturing Science & Technology (MSAT) mission by driving commercial manufacturing processes improvements in Process development laboratories, providing technical expertise in various process disciplines.

This team aims to optimise the performance of manufacturing systems. They are resposible for identifying and developing new processes for product manufacture, as well as putting in place process controls to make sure the products are of a high quality and are manufactured in a reproducible manner. MSAT Process Science & Manufacturing Technology team leads studies on process improvements, technology transferse, scale up and trouble-shooting of process-related issues, and will assist other MSAT teams in charge of managing deviations by generating suportive data required by PIA. They develop new ideas and scientific discoveries, which can be used in the manufacture of new products. They carry out laboratory studies using small scale manufacturing models to support root cause investigations and evaluate process improvements. Supports other arms of MSAT (MSAT Manufacturing support, MSAT Product Stewardship, MSAT Technicial Transfer) in reviewing and advising on data generated from trials/investigations/etc. Level 3 or 4 experts to consult on product and process.

Senior Scientists are in charge of process development projects as well as new process and new technology development. They are responsible of identifying and developing new innovative technologies/processes that reduce cost, enhance features, or optimize manufacturing operations. They maintain technological awareness of the site current practices and new technologies to be implemented and ensure vaccine development to meet the targets set by the Target/Asset product profile (TPP/AP) with optimal quality.

They work with research scientists to develop new ideas and scientific discoveries, which can be used in the manufacture of new products.

They are responsible of the management of process development lab and pilot plant (infrastructure, equipment, logistics, maintenance, qualification and validation of equipment, operating licence,...).

Senior Scientists report to Process Science & Manufacturing Technology Development Manager or Head of MSAT department.

Responsibilities

Process development:

Research, develop and recommend new innovative technologies/processes that reduce cost, enhance features, or optimize manufacturing operations.

Design and develop processes to optimize efficient process flow, reduce process or product variability, improve process capability, and improve employee safety.

Develop, verify, and validate products from process development to successful commercialization.

Determine process capability for all developed processes.

Ensure that process techniques are in alignment with the corporate goals and quality policy.

Set up designed process experiments, evaluate results, and effectively communicate conclusions. Projects will be self-directed, collaborative, and combine research and lab trials.

Execute process development or scaling-up of vaccine bulk manufacturing processes (bacterial/ chemical/ logistic technologies) for one project.

The scope of work will include supporting GMP investigations and change controls, designing and executing experiments, authoring memos and technical reports, and improving manufacturing processes to reduce reoccurring deviations. Interact extensively with other departments including VS, QA, QC, SCM and TS.

In partnership with MSAT Learning team, develop and education/training plans to facilitate the dissemination of knowledge of Product/Process improvement and systems thinking strategies, tools, and practices across the organisation.

Process Life Cycle Management:

Provide technical assistance to commercial manufacturing team, including change assessment, process monitoring, troubleshooting and continuous improvement.

Technology transfer:

Contribute and/or lead technology transfer and associated comparability requirements.

May be reponsible for feasibility studies and field trails management where substantial new development is involved.

Process development infrastructure management:

Manage process development laboratory and pilot plant. This includes infrastructure, equipment, logistics, maintenance, qualification and validation of equipment, operating licence, administrative tasks, LEAN operational excellence and change management.

Collaborations with Technology and research institute as a vital element of open innovation approach to continuous improvements:

Participate to partnerships with research institutes, technology giants, biotech companies to develop new innovative projects to allow GSK to jumpstart Process development activities before making major capital investments.

Build lasting relationships between researchers and industry partners to enhance to help address critical process issues.

Environment, Health, Safety and Wellness:

Support, promote and participate in site\'s safety and wellness initiatives. Be a role model when appointed as a EHS Committee member, advocate and display safe behaviour and mindset at all time.

Contribute and support EHS training activities aligned with Site vision and goals.

Use PPEs correctly while working and follow the safety training and safety instructions and health rules and regulations.

Contribute to the establishment of an active workplace safety. Be continuously on the lookout for anything that could lead to an accident. Be aware of the behaviour of colleagues too.

Make daily safety inspections, provide input and feedback. about safety problems and solutions.

Report all near miss accidents, dangerous occurrences or unsafe situations.

Participate in enforcement inspections.

Comply with all applicable safety standards.

SME (where applicable):

Provide technical consultancy to technical staff and non-technical staff as needed.

Develop and deliver training masterials and curricula, covering a range of technical, operational areas in a specified field.

Communicate complex engineering designs/concepts to technical audiences in an efficient and effective manner.

Monitor and assess new developments, industry trends, evolving regulatory expectations in area of expertise.

Participate in network of locan and global experts and sharing of best practices and learnings in area of expertise.

Where applicable, oversee junior-level MSAT staff on relevant business and mentor junior-level staff.

Knowledge, Skills & Experience

MS/BS degree with relevant experience in Vaccines Process Science, Pharmaceutical R&D or Bioprocess Engineering.

PhD would be an advantage

Relevant experience in the bio/pharmaceutical industry in Process Development, R&D or MSAT.

At least 3 - 7 years\' experience in biopharmaceutical process development and healthcare business system (R&D, process development, technology transfer, process scale-up/ scale-down).

Experience in DoE tools and QbD.

Knowledge of current Regulatory guidance on late stage and continued process verification requirements.

Good understanding of FDA/EMEA/ICH/cGMP guidance documents.

Experience in cGMP during pharmaceutical process development and commercial manufacturing or process characterization.

Proven track record in the development of systems, processes and procedures to streamline operations.

Very strong background in vaccines process development or manufacturing process optimisation.

Understanding of Life Cycle Management disciplines, cross functional skills and processes (e.g. Continuous Process Validation, Process evaluation,..).

Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.

To learn more about Singapore GSK and our people, please click on this link:

#Li-GSK

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

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.\xe2\x80\x8b

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.

GlaxoSmithKline