Investigator, Biopharm Downstream Process Development
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jan 12 2021 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. You 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: Design, execute and interpret protein purification experiments Apply Quality by Design principles to process design Utilize statistical analysis and advanced data analytics for process understanding and improvement. Work 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. Evaluate and integrate innovative purification technologies Write and review technical documents, authoring of CMC sections for regulatory filings Mentor junior scientists Present data and status reports to senior management Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD or equivalent experience in Chemical/Biochemical Engineering, Biochemistry, Chemistry; or related Biological Science Extensive theoretical and practical experience and understanding of protein purification and protein chemistry Preferred Qualifications: If you have the following characteristics, it would be a plus: Expert in protein purification and process development Ability to apply expertise to identify and evaluate new technologies for 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. Why GSK? Our values and expectations are 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 GSKBiopharm_Development If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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. 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