Scientific Leader, Downstream Process Development

Job title: Scientific Leader, Downstream Process Development

**LOCATION: King of Prussia, PA & Upper Merion - onsite**

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Scientific Leader, Biopharm Downstream Process Development role could be an exciting opportunity to explore.

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.

Drug Substance Development (DSD) 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 pre-clinical development through commercialization. These activities are delivered through state-of-the art internal facilities as well as strategic external partners. As a key arm of the DSD organization, the Biopharm Drug Substance Development (BDSD) department is accountable for the CMC deliverables for the Biopharmaceutical portfolio, through cell line development support, cell culture/microbial fermentation development, and purification development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience, at an accelerated pace.

Within BDSD, the downstream development group is responsible for the development, scale-up, and technology transfer of purification processes to manufacturing facilities all over the world. The group is responsible for integrating innovative process platforms, technologies, automation, and advanced data analytics into the downstream process development workflow. An opportunity has arisen for a Scientific Leader with the ability to support early and late-phase process development, characterization, and successful technology transfer to manufacturing facilities. The successful candidate will influence business processes, evaluate new technologies, and integrate them in the downstream process platform. The individual will work collaboratively with the scientists and scientific leaders with the expertise and experience in cell line development, media development, downstream development, externalization, and CMC strategy development, and with the clinical/commercial manufacturing organizations.

As Scientific Leader, in Biopharm Downstream Process Development, the successful candidate will lead a team of 3-5 scientists/engineers responsible for developing early to late-stage purification processes for manufacturing biopharmaceuticals. This team will be involved in the scale-up and technology transfer of manufacturing processes to produce clinical supplies and commercial-scale protein production. The team will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents, and CMC sections of regulatory filings. In addition, the team will lead and/or participate in on-going technology development efforts within the department. The successful candidate will participate in strategic planning for the direction of the Department and the Biopharm CMC organization by making presentations to senior management, providing proposals, and periodic updates on the portfolio and technology projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• Impact and influence the overall direction and success of projects or processes, using knowledge of multiple disciplines or technologies.
• Lead and develop scientists within the team.
• Provide functional leadership to the project teams for early- and late-stage process development.
• Lead and participate in ongoing platform development initiatives, through development and implementation of new technologies.
• Participate in strategic planning for the direction of the upstream function and BDSD department.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD in Chemical/Biochemical Engineering or related Biological Science with 5+ years of industrial experience in the Biotech industry. OR BS / MS in Chemical/Biochemical or related Biological Science with 10+ years of industrial experience in the Biotech industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Demonstrated experience in developing purification processes for biopharmaceutical production with understanding of cGMP requirements.
• Understanding of small-scale model qualification and challenges faced during scale-up.
• Experience in technology transfer to manufacturing sites.
• Hands-on experience with process scale-up/process characterization.
• Experience in authoring CMC sections for regulatory filings.
• Familiarity with current QbD approaches and Control Strategy Development.
• Authoring and review of BLA & MAA drug substance modules
• Knowledge of Process Validation requirements.
• Demonstrated mastery of handling large sets of data, including statistical analysis.
• Detailed knowledge of multivariate analysis and DoE approaches.
• A thorough theoretical understanding of the workings of chromatography, filtration and centrifugation.
• Experience with CMOs through tech transfers and relationship management.
• Prior experience within a MSAT organization, in receiving the developed processes, supporting manufacturing campaigns, investigating mfg. deviations, and implementing corrective actions, is a plus.
• Experience in developing and implementing business processes and technical guidelines to bring efficiencies in process development.

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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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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