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Investigator- Biopharm Drug Product Development

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jun 24, 2022

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Discipline
Other, Other
Job Type
Group Leader/Principal Investigator
Organization Type
Pharma
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We are building astate-of-the-artend to end Biopharm capability whichdelivers efficient discoveryof antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, wediscover, develop, and manufacturenovelportfolio of exciting medicinestobenefit patients around the world.If you aim to be part of a globalcutting-edge drug development and discovery organizationand are motivated to contribute towardsbringing lifesaving drugs to patients, join us!

Click here to know more about GSK Biopharm.

#GSKBiopharm_Development

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 opportunity within the Drug Product Technology Development and Process Engineering team could be the right fit for you. Our team is passionate about the work we do, and we'd be eager to welcome individuals with a similar interest in using technology to develop medicines.

As an Investigator, 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 during drug product development.

This multi-disciplinary role will provide YOU a great opportunity to pursue your interests and develop your career. Our group has great mentors who are generous with their time and guide members in their career path. You will have the opportunity to lead key activities in Drug Product Development to progress YOUR career. Some of the key activities you will be involved with are:

  • Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) scientists, automation experts, data scientists, device engineers, and engineers from R&D Pilot Plants and Global Supply Chain manufacturing sites, to systematically understand unit operations involved in drug product manufacture and to scale-up these processes effectively.


  • Actively participate in and lead technical reviews on projects, and contribute to the technical transfer of processes, including the leadership of technical transfer activities on behalf of the discipline, preparing functional project plans, and ensuring timely execution. Contribute to CMC and MPD team planning and objective setting, agreeing priorities and coordinating Process Engineering and Analytics activities that support delivery of objectives.


  • Using your sound practical and theoretical understanding to ensure that appropriate experimental data and models are used to solve complex process development problems. 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.


  • Minimize number of DOE's for scalability assessments and API consumption throughout the development life-cycle by driving smart decisions at appropriate milestones within the project plan.


  • 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.


  • 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, automate development work packages and establishing control strategies. Be accountable for platform robustness across the portfolio.


  • Become an expert in specific unit operations primarily within the sterile biopharm portfolio. Additionally work very closely with automation team and data scientists to automate work packages and standardize data generation and analysis.


  • Utilize effective planning to deliver the above efficiently and where required, enable work packages to be automated or outsourced.


  • 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:

We are looking for professionals with these required skills to achieve our goals:
  • Knowledge of proteins, formulation development, and drug product process development, and regulatory requirements/submissions
  • Ph.D. in Chemical Engineering, Pharmaceutical Sciences or related field with 1-3 years of protein formulation, process development and drug delivery development experience; or, MS degree with 5-7 years of similar experience; or BS degree with 8 or more years of similar experience.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ability to multi-task and manage workload independently.
  • Ability to work within a matrix team environment and communicate effectively.
  • Experience in or exposure in an academic context to 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 in evaluating, developing, and qualifying manufacturing equipment.
  • Publications in peer reviewed journals


Why GSK?

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

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 is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed; and where 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.​

GSKBiopharm_Development

*LI-GSK

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