Scientific Leader, Downstream Process Development
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jun 30 2021 Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Biopharm Downstream Process Development role could be an exciting opportunity to explore. GSK's Biopharm development platform is reliable and proven, with clear strengths in antibody discovery, formulation, analysis and drug substance manufacture. This success has led to increased investment in the Biopharm business, with the aim of delivering industry leading Biopharm capabilities that will enable design for developability, improve biopharm quality and accelerate portfolio fill and flow. Working in GSK Biopharm provides employees the opportunity to engage with different parts of the business so they can develop and grow their professional skills and network. The co-location of Biopharm development, clinical manufacture, analytical testing and commercial manufacture at the Upper Merion campus provides a unique opportunity to up-skill staff and facilitate the transfer of new products and technologies from Research and Development to Pharma Supply Chain. 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 Scientific Leader in Downstream Process Development, you will be responsible for leading the development of recovery and purification processes for both early- and late-stage biopharmaceutical assets. You will manage a highly skilled team of scientists, engineers, and technicians responsible for the evaluation, optimization, and transfer of purification processes. You will be involved in all aspects of process development 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. Overall, the technical focus of your team will be on the bench-scale and pilot-scale laboratory development of purification unit operations such as column chromatography, ultrafiltration, depth filtration and continuous centrifugation. Although your team's primary responsibilities will be predominantly scientific- and lab-based, the role requires strong verbal and written communication skills and requires exceptional ability to organize. Both individual and team working are required. Therefore, the role will suit an experienced scientist with excellent interpersonal skills, self-motivation, and an open mindset. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor of Science in Biochemistry, Chemistry, Biology, Pharmaceutics or equivalent; (MS or PhD highly preferred) 4 years' of industry experience in therapeutic protein purification process development Experience in therapeutic protein purification, process development, and technology transfer Experience with drug development and of regulatory requirements in the industry, including familiarity with cGMPs. Experience contributing to CMC matrix project teams US work authorization is required for this role. Sponsorship is currently not available. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree in Science (MS or PhD) Experience with both early- and late-phase development of purification processes, process scale-up, technology transfer (internal and to external CMO), process validation and BLA/MAA preparation for biopharmaceuticals. Previous experience demonstrating strong business acumen in supporting process development and manufacturing activities is strongly preferred. Requires excellent oral and written communication skills to effectively deliver portfolio programs. Broad and integrated knowledge and experience that can impact project and work-group direction. Demonstrated record of innovation and technology development. Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design and virus clearance validation. Experience with purification of protein products from both mammalian and microbial cell culture. Experience executing performance management cycle activities. Involvement in external scientific and industrial community as demonstrated by a track record of presentations, publications and participation in conferences. Demonstrated ability to supervise and mentor others. Experience recruiting and training staff. 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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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