Investigator, Process Engineer

As the Process Engineering team member in the US Process Engineering & Analytics – Sterile NCE Drug Product & Biopharm group you will be responsible for employing knowledge and experience of Formulation Unit Operations, Process Engineering, and Modeling to support the development and scale-up of formulations through to commercialization.

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

• To work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Engineers, Modelers, Materials Scientists and Particle Scientists, to deliver the work packages required to understand formulation unit operations and scale these-up effectively.
• To make innovative contributions to the department by providing experimental data, technical insight and modeling of data to solve complex process development problems using excellent practical and theoretical understanding.
• 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 NCE portfolio.
• Identify opportunities for the development of hybrid modeling approaches and support engineering in the postulation of mechanisms for physiochemical processes through data mining.
• Use engineering, chemical or materials science knowledge to postulate mechanisms for physiochemical processes and develop or modify existing mathematical models to describes those mechanisms.
• Perform or direct experimentation and analysis (e.g., chromatography, PAT, physical properties testing) required to develop (e.g., parameter fitting) and verify system models.
• Translate mathematical models to computer models using software platforms (e.g. gPROMS, Aspen, and DynoChem) or by writing custom programs (e.g., Using Matlab, Python, etc.)
• Develop and maintain key system modeling platforms.  Leverage external expertise and funding through pre-competitive alliances (e.g., System based Pharmaceutics)
• To 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.
• To advance scientific understanding and improve current ways of working in field of expertise by actively participating in internal or external technical focus networks, external collaborations with academics, and applying knowledge of the current literature.
• To enable sound decisions by your influence in matrix teams and technical governance, through depth of technical knowledge and effective communication.
• Utilize effective planning to deliver the above efficiently and where required, enable work packages to be outsourced.
• To deliver the above in a precise and timely manner, adhering to safety and quality expectations.
• Be technically persuasive both within GSK, for example, at project governance, with peers in other departments, or externally, with the academic community
• Demonstrate innovative thinking and be able to clearly drive the development of the Process Engineering discipline and Platform Design as a whole.
• Comply with the requirements of cGMP, Safety and GSK policies and procedures

Individuals with more experience may act as a single point of contact for a specific Drug Project / Platform and may be responsible for:

• Contributing to CMC and MPD team planning and objective setting, agreeing priorities and coordinating Drug Product Process Engineering activities that support delivery of objectives.
• Developing and communicating the technical strategy for Drug Product Process Engineering & Analytics core accountabilities within the Drug Product Process Engineering & Analytics line.  This includes leading a multidisciplinary Drug Product Engineering team, preparing functional project plans and ensuring timely execution.
• Ensuring appropriate scientific review is in place throughout development and prior to PPD ST/NPS Board and internal governance decisions. Prepare and deliver Drug Product Process Engineering-relevant sections of PPDST and NPS Board presentations and respond to resulting questions. Identify and escalate Drug Product Process Engineering-related risks at scientific reviews and through PPD and NPS processes.
• Authoring sections of regulatory documents relevant to Drug Product Process Engineering and platforms (IND / IMPD submissions, marketing applications, CMC briefing etc.). Ensuring the delivery of API stage technology transfer activities as cross functionality and reports as appropriate for transfer to IMO, GMS, or a 3rd party manufacturer.
• Ensuring proper Materials Science 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.

Competencies

• A proven track record and demonstrated practical experience in formulation unit operations, modeling, materials science and scale-up, to deliver processes that are well understood and deliver to clinical and commercial milestones.
• Be a champion for the introduction of new technologies/platforms and new ways of working.
• Experience in the application of state-of-the-art laboratory equipment and modeling software.
• A working knowledge of particle formation, formulation process development, and material sciences
• A working knowledge of the drug development process including regulatory aspects.
• Demonstrated experience in project management and use of risk-based approaches.
• A working knowledge of Quality by Design (QbD) principles and their application.
• A demonstrated ability to handle several projects in different stages of development at the same time, using initiative and imagination to meet agreed objectives and timelines.
• Highly effective interpersonal, organizational and communication skills for working in a multi-disciplinary high-paced scientific team environment.

Basic Qualifications:

• BS. In Chemical or Mechanical Engineering, Pharmaceutical Sciences or related field.
• Ability to multi-task and manage workload independently.
• Ability to work within a team and communicate effectively.
• Understanding of engineering first principles and process scalability.

Preferred Qualifications:

• M.S. or Ph.D. in Chemical or Mechanical Engineering, Pharmaceutical Sciences or related field.
• 5+ years of previous pharmaceutical industry experience.
• Publications in peer reviewed journals.