MSAT Process Science Lab Expert Scientist- Drug Product

Job description

Your Responsibilities :
The Process Science Lab Expert Scientist works within the Local MSAT/Global MSAT teams.
He/she is responsible for managing drug product/drug substance projects to facilitate global supply of quality and compliant commercial vaccines with high reliability and manufacturability by ensuring robust Drug Substance/Drug Product processes and by providing state-of-the-art product and process expertise to support manufacturing issues or need for troubleshooting and investigations. He/she therefore develops, runs and maintains small scale production model, along with access to respective analytical tools.

He/she establishes and maintains strong collaboration and interaction both locally and globally with internal (Local MSAT/Global MSAT) and external (TRD, Quality, etc...) partners and contribute to project plans for delivering the expected product and process innovations and knowledge.
He/she ensures that the content and quality of report used for regulatory submissions meets the requirements in all markets for the products. He/she will build expertise and competencies to support Life Cycle Management team to bring the best technical solutions to commercial vaccine product manufacture, with minimum complexity, cost of goods and meeting the agreed Quality Target Product Profile for the post-approval change. He/she liaise with technology steward (LMSAT) and Manufacturing Technology (GMSAT) to enable the testing of new technology to accelerate the implementation in manufacturing.

As part of his/her job he/she acts on the lab shop floor by performing experiment and by participating to the organization of the laboratory experiments done by technicians. He/she defines the project development strategy with the manager and also provides protocols and reports describing the methodology and the results of the lab trials.

Key Rosponsibilities:
• Designs and execute specific project autonomously, in line with business priorities, following the Quality by Design framework
• Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects. Authors and reviews technical protocols and reports in support of various project.
• Makes sound scientific / technical and business decisions based on a balance of data, analysis and experience.
• Solves complex problems through collaborations with others, taking a new perspective on existing solutions.
• Provides technical leadership and specific product based scientific support for projects, small scale experiments technical investigations to fully support commercial processes throughout their lifecycle
• Implements and maintains meaningful downscale models for critical process steps for primary or secondary operations and ensures analytical tests are available and meaningful
• Improves process understanding and control to meet the growing requirement by Regulatory Authorities through capability building
• Responsible for the appropriate standards of quality, housekeeping and safety being applied within the Process Science, in accordance with the quality framework
• Networks with other site, Process Science & with R&D (TRD) to speed-up investigation/improvements.
• Spends part of his/her time to train production people in his/her field of expertise & acts as a resource for colleagues with less experience.
• Prepares and presents scientific data within GIO and defend scientific and technical decisions at the appropriate technical board (ie TRB)
• Efficiently manages laboratory resources in support of product related projects and changes
• Benchmarks specific technologies in own functional area to bring technology to state of the art. Propose technical plan to meet GIO expectations through LMSAT consolidation.

*LI-GSK

Why You?

Basic qualifications:
• Fluent in English and proficient in site local language.
• Minimum 4 years experiences in a laboratory role, pilot plant or equivalent experience
• Proven scientific knowledge of Vaccines manufacturing and analytical testing
• Relevant experience in data interpretation and utilization, working knowledge of applied statistics essential..
• Good understanding of Operations & GMP's
• PhD with 1+ years of post-doc and/or job-related experience / MS with 5+ years of experience / BS with 8+ years of experience.

• Experience in managing a matrix organization as well as a day to day team
• Experience in project management
• Ability to influence and negotiate at all levels of the organization in order to meet objective or deliverable
• Adept at stakeholder management and excellent communication skills are necessary to meet needed mindset and behavioral changes that will be required by the business
• Ability to drive change
• Good knowledge of analytical techniques
• Awareness on Quality by Design and Lifecycle Process Validation requirements
• Experience in technology transfer and scale-up of drug product processes is a plus
• Expertise in at least 1 or 2 different technologies (Cell Culture, Fermentation, Formulation, Filling, Lyo,…)

Preferred qualifications:
Preferably PhD in Science, Pharmaceutical Technology, Chemistry or equivalent scientific area

If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.

Why GSK? :
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com.

Our Department:
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

Contact information:
You may apply for this position online by selecting the Apply now button.

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