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Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals?If so, this Investigator, Biopharm Downstream Process Development role could be an exciting opportunity to explore.
Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development.We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.
Within Biopharm Process Development, the Downstream Process Development department is responsible for the development of purification processes for the manufacture of GSK's Biopharm assets.The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world.Our aim is to integrate innovative process platforms, automation and advanced data analytics into the downstream process development workflow.In our mission, we follow the science and are committed to the design, development, and transfer of the most robust, well-understood, and well-characterized downstream manufacturing processes and platforms that will ensure quality and reliable supply of medicines for the patient.
As an Investigator in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. Y ou will be involved in all aspects of the development of purification processes including initial process screening, optimization, characterization, scale-up and tech transfer to clinical manufacturing and/or commercial manufacturing partners for therapeutic proteins including monoclonal antibodies, and antibody-drug conjugates . Your primary focus will be on the bench-scale laboratory development of purification unit operations such as column chromatography (affinity, ion exchange, HIC, mixed mode, etc.), ultrafiltration, depth filtration, nanofiltration and continuous centrifugation. Although predominantly lab-based , the role also involves verbal and written communication and requires good organisation as well as a broader scientific knowledge. Both individual and team work are required and therefore the role will suit a scientist with good interpersonal skills, self-motivation and an open mindset.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you? Basic Qualifications:
- Designing, executing and interpreting protein purification experiments
- Applying Quality by Design principles to process design
- Utilizing statistical analysis and advanced data analytics for process understanding and improvement.
- Working with matrix teams in Biopharm Process Development Sciences to integrate results into process designs and overall project plans
- Scale-up and technology transfer of manufacturing processes.
- Evaluating and integrating innovative purification technologies
- Writing and reviewing technical documents, authoring of CMC sections for regulatory filings
- Mentoring junior scientists
- Presenting data and status reports to senior management
We are looking for professionals with these required skills to achieve our goals:
- PhD or or Bachelors/Masters and 8+ years industry experience.
- Experience identifying and evaluate new technologies for process development.
If you have the following characteristics, it would be a plus:
- Extensive theoretical and practical understanding of protein purification and protein chemistry.
- Expert in protein purification and process development
- Demonstrated record of scientific achievement and a broad and integrated knowledge of the field.
- Experience in scale-up and technical transfer for clinical and commercial manufacturing
- Knowledge of continuous processing.
- A developing understanding of regulatory standards (viral safety, process validation, GxP, etc.)
- Knowledge of Quality by Design and control strategy development
- Demonstrated ability to work as part of a project team.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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