Principal Scientist in Steriles Process Engineering and Analytics

GSK•Upper Providence Township, PA

1d•Hybrid

About The Position

This opportunity within the Technology Development and Process Engineering team is for an individual energized by the challenge of designing innovative ways to use Engineering, Process Analytics Technologies, Automation and Modelling to develop medicines for patients. The team in the Technology Development and Process Engineering group is passionate about the work they do and would welcome individuals with a similar interest in using technology to develop medicines. As an Principal 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 Sterile drug products (Biopharms, small molecule suspensions, ADCs, oligonucleotides, Vaccines) 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. The 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.

Requirements

Ph.D. in Chemical Engineering, Biochemical Engineering, or related field
Experience in protein formulation and/or drug product development and technology transfer
OR MS degree with 10+ years of related experience
OR BS degree with 13+ years of related experience

Nice To Haves

Experience in or exposure in an academic context to Sterile drug product (e.g., Biopharma, suspensions, ADCs, oligonucleotides, or Vaccines) development 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

Responsibilities

Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modelers, 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, 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 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.