Investigator, Downstream Process Development
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Dec 17 2020
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. As a member of the Virus Clearance team, your primary focus will be on virus clearance validation for therapeutic proteins including monoclonal antibodies. Responsibilities include study design, management of contract laboratory studies, data analysis and reporting. The role 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. The responsibilities include some of the following:
- Designing, executing and interpreting virus clearance experiments
- Writing and reviewing technical documents, authoring of CMC sections for regulatory filings
- Working with matrix teams to progress multiple projects in the Biopharm pipeline
- Applying Quality by Design principles to process design
- Evaluating and integrating innovative technologies
- Mentoring junior scientists
- Presenting data and status reports to senior management
- PhD or equivalent experience in Chemical/Biochemical Engineering, Biochemistry, Chemistry; or related Biological Science
- Experience with regulatory standards (viral safety, process validation, GxP, etc.)
- Experience with the principles, methods, experimental approaches, and regulatory requirements of virus clearance validation for biopharmaceuticals
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Expert in protein purification and process development
- Extensive theoretical understanding and practical experience of virus clearance validation for biopharmaceuticals
- Demonstrated record of scientific achievement and a broad and integrated knowledge of the field
- Knowledge of continuous processing
- Knowledge of Quality by Design and control strategy development
- Demonstrated ability to manage external contract research organization activity.
- Ability to apply expertise to identify and evaluate new technologies for virus clearance
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.
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