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Scientific Leader

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Sep 25, 2022

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Discipline
Physical Sciences, Chemistry
Organization Type
Pharma
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Are you energized by the challenge of designing innovative ways to use Engineering, Process Analytics Technologies, Automation and Modelling to develop medicines for patients? If so, this Technology Development and Process Engineering opportunity could be an exciting opportunity to consider.

GlaxoSmithKline 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 Product Development (part of the wider Medicine Development and Supply organization) 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 both small molecule and biopharm drug product/ device development and packaging. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

As a Scientific Leader, you will employ knowledge and experience of drug product unit operations, Process Engineering, and modelling to assess, develop and implement new manufacturing platforms and support scale-up, technology transfer and manufacture of Biopharmaceutical drug product through to commercialization. You will work very closely with automation experts and data scientists to enable efficiencies across all drug product development work packages. The role may require management of a direct report or reports.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… (comes from key responsibilities on job eval)

  • Work as process engineering and analytics (PE&A) lead in a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers, to deliver the work packages required to understand drug product unit operations and scale these-up effectively.


  • Actively participate in technical reviews on projects, lead the technical transfer of processes, prepare functional project plans, and ensure timely execution. Contribute to CMC and MPD team planning and objective setting, agreeing priorities and coordinating PE&A activities that support delivery of objectives.


  • Ensure proper Process Engineering decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and minimize number of DOE's for scalability assessments and API consumption throughout the development life-cycle.


  • Author sections of regulatory documents relevant to Process Engineering platforms (IND / IMPD submissions, marketing applications, CMC briefing etc.).


  • Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms and establishing control strategies. Be accountable for platform robustness across the portfolio.


  • The job holder may act as an expert in specific unit operations. As such, they will be expected to master a body of knowledge for that unit operation and use this to act as the functional expert in the department. This expertise will be focused on platform and process primarily within the sterile biopharm portfolio


  • Be technically persuasive both within GSK, for example, at project governance, with peers in other departments, or externally, with the academic community. Ensure appropriate scientific review is in place throughout development and prior to key Project milestones. Prepare and deliver Process Engineering and Analytics-relevant sections of technical and governance presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews and through governance processes.


  • Advance scientific understanding and improve current ways of working in field of expertise by actively championing deployment of new automation and PAT tools and models for drug product development, participating in internal or external technical focus networks, external collaborations with academics, and applying knowledge of the current literature.


  • Enable sound decisions by your influence in matrix teams and technical governance, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites


  • Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.


Why you?

Basic Qualifications:

The ideal candidate will have a:

  • Ph.D. in Chemical Engineering, Pharmaceutical Sciences or related field with 7+ years of protein formulation and/or drug product development experience; or MS degree with 10+ years of similar experience; or BS degree with 13+ or more years of similar experience.


Preferred Qualifications

If you have the following characteristics, it would be a plus:
  • Experience in Biopharm drug product process development, characterization, scale -up and technology transfer modelling, and, to deliver processes that are well understood
  • Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
  • Experience evaluating, developing, and qualifying manufacturing equipment.
  • Establishing control strategy for biopharm drug product manufacturing
  • Proven ability to lead collaboratively in a matrix style environment
  • Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals
  • Author DP sections of regulatory documents (IND/IMPD, BLA/MAA/JNDA, etc.)
  • Biopharmaceutical product development including formulation, stability, process development/characterization and technical transfer
  • Bioanalytical and biophysical testing, and data analysis
  • Demonstration of data integrity principles
  • Mentoring/developing staff in proper scientific study design, execution, and report writing


Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. ​



With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. ​



Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster; accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. ​

*LI-GSK

#LI-GSK

#CMCDevelopmentGSK

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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