GSK

Senior Scientist, Downstream Process Development, Biopharm Process Development

Employer
GSK
Location
King of Prussia, PA
Salary
Competitive
Posted
November 03 2020
Ref
269285
Organization Type
Pharma
Job Type
Senior Scientist
Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Senior Scientist, 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 Senior Scientist 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. You will be involved in all aspects of the development of purification processes including initial process screening, optimization and 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 and continuous centrifugation. Although predominantly lab-based, the role also involves verbal and written communication and requires good organization. Both individual and team working 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:
  • Designing, executing and interpreting protein purification experiments
  • Working with matrix teams in Biopharm Process Development Sciences to integrate results into process designs and overall project plans
  • Applying statistical analysis and advanced data analytics to gain process understanding and improvement.
  • 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


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Master's degree (Chemical Engineering, Biochemistry, Chemistry or Biology) with 2 years relevant industrial experienceand/or combination of education and experience (e.g. Bachelor's degree and 4 years' experience)
  • Previous experience in protein purification and process development
  • Advanced knowledge of laboratory and manufacturing equipment and procedures relating to purification and separations.


Preferred Qualifications:

If you have the following characteristics, it would be a plus :
  • Expert in protein purification and process development
  • Experience in scale-up and technical transfer to clinical and/or commercial manufacturing
  • A developing understanding of regulatory standards (viral safety, process validation, GxP, etc.)
  • Demonstrated ability to work as part of a project team.
  • The ability to plan and execute experiments, and to analyze and draw conclusions from resulting data.
  • Demonstrated achievement in learning new techniques independently.
  • The ability to plan and execute experiments, and to analyze and draw conclusions from resulting data.
  • Demonstrated achievement in learning new techniques independently.


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


*LI-GSK

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