Scientific Leader, Biopharm Upstream Process Development
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Aug 3 2020
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
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 Microbial and Cell Culture Development department is responsible for the development of cell culture 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 expression and process platforms, automation and advanced data analytics into the upstream process development workflow. An opportunity has arisen for a process development scientist with ability to advance the perfusion platform and handle large sets of complex data. He/she will have the opportunity to develop new methods and build capability in automated workflows and data handling.
In this role, you will lead a team of 4-6 scientists/engineers responsible for developing late stage cell culture processes for manufacturing biopharmaceuticals using mammalian expression systems. This team is involved in the scale-up and technology transfer of manufacturing processes for the production of Phase-3 clinical supplies and commercial-scale protein production. You and your team will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents, and CMC sections in regulatory filings. In addition, you and your team will lead and participate in on-going technology development efforts within the Department. These include the development of proprietary cell culture media and feed, improving the efficiency and productivity of our platform processes, and the application of PAT for cell culture processes. You will participate in strategic planning for the direction of the Department and the BioPharm CMC organization by making presentations to senior management, providing periodic progress updates on projects and proposals for new technology development initiatives and advanced data analytics.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Manage and provide development opportunities for of a small team of junior scientists
- Represent the department on project teams
- Lead and participate in ongoing platform development initiatives including the development of perfusion/continuous upstream processes and technology development efforts
- Participate in strategic planning for the direction of the department and the Biopharm CMC organization
We are looking for professionals with these required skills to achieve our goals:
- PhD or equivalent experience in Chemical/Biochemical Engineering or related Biological Science with 7+ years of industrial experience in the Biotech industry
- Experience in developing cell culture processes for biopharmaceutical production with exposure to cGMP requirements
- Experience in technology transfer to manufacturing sites
- Hands-on experience with process scale-up/process characterization
- Experience in authoring CMC sections for regulatory filings
- 4+ years of supervisory experience leading technical teams
If you have the following characteristics, it would be a plus:
- Familiarity with current QbD approaches and Control Strategy Development
- Very good understanding of small-scale model qualification and challenges faced during scale-up
- Good communication skills and ability to work in matrix teams
- Authoring and review of BLA & MAA drug substance modules
- Detailed knowledge of Process Validation requirements
- Working knowledge of PAT tools such as Raman, capacitance probes, and in-line UV measurements
- Demonstrated mastery of handling large sets of data, including statistical analysis using software packages such as JMP/SIMCA/etc.
- Detailed knowledge of multivariate analysis and DoE approaches
- A thorough knowledge of the workings of large scale bio-reactors, especially aspects concerning mass transfer and mixing times
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:
- 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.
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.
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