Investigator, Process Engineering
Job
Responsibilities:
Work as process engineer in a multi-disciplinary development team, liaising efficiently with Formulators, Modelers, 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, and ensure timely execution.
Contribute to CMC and MPD team planning, 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.
Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms.
Be accountable for platform robustness across the portfolio.
The job holder may act as an expert in specific unit operations.
This expertise will be focused on platform and process primarily within the sterile small molecules and/or biopharm portfolio.
Prepare and deliver Process Engineering and Analytics-relevant sections of technical presentations and respond to resulting questions.
Identify and escalate Process Engineering and Analytics-related risks at scientific reviews.
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, and applying knowledge of the current literature.
Enable sound decisions by your influence in matrix teams, 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.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.
Basic
Qualifications:
PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 0-2 years of related experience OR Master's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 3
years of related experience OR Bachelor's degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 5
years of related experience Preferred
Qualifications:
The ideal candidate will have a Ph.
D.
in Chemical Engineering, Pharmaceutical Sciences or related field with 2
years of steriles drug product - Process Engineering development experience; or MS degree with 5
years of similar experience; or BS degree with 7
years of experience.
Experience in steriles 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 steriles drug product manufacturing.
Proven ability to lead collaboratively in a matrix style environment.
Steriles product development including formulation, stability, process development/characterization and technical transfer.
Demonstration of data integrity principles.
Mentoring/developing staff in proper scientific study design, execution, and report writing.
Working Environment:
Position is in a research laboratory environment.
Job pace may be fast and job completion demands may be high.
Must be able to remain in a stationary position more than 25% of the time.
Potential risk to lab-based hazards including but not limited to chemicals, biologicals, potent compounds, research material, high temperature, etc.
The person in this position needs to occasionally move inside and outside labs.
Frequently use objects, tools or controls, which will require regular bending, squatting, stretching and reaching in order to perform in a service function.
Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument/equipment), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
Employee may be required to handle hazardous wastes according to local, state, and federal regulations.
Recommended Skills Api Assessments Automation Biology Chemical Engineering Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Work as process engineer in a multi-disciplinary development team, liaising efficiently with Formulators, Modelers, 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, and ensure timely execution.
Contribute to CMC and MPD team planning, 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.
Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms.
Be accountable for platform robustness across the portfolio.
The job holder may act as an expert in specific unit operations.
This expertise will be focused on platform and process primarily within the sterile small molecules and/or biopharm portfolio.
Prepare and deliver Process Engineering and Analytics-relevant sections of technical presentations and respond to resulting questions.
Identify and escalate Process Engineering and Analytics-related risks at scientific reviews.
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, and applying knowledge of the current literature.
Enable sound decisions by your influence in matrix teams, 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.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.
Basic
Qualifications:
PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 0-2 years of related experience OR Master's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 3
years of related experience OR Bachelor's degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline 5
years of related experience Preferred
Qualifications:
The ideal candidate will have a Ph.
D.
in Chemical Engineering, Pharmaceutical Sciences or related field with 2
years of steriles drug product - Process Engineering development experience; or MS degree with 5
years of similar experience; or BS degree with 7
years of experience.
Experience in steriles 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 steriles drug product manufacturing.
Proven ability to lead collaboratively in a matrix style environment.
Steriles product development including formulation, stability, process development/characterization and technical transfer.
Demonstration of data integrity principles.
Mentoring/developing staff in proper scientific study design, execution, and report writing.
Working Environment:
Position is in a research laboratory environment.
Job pace may be fast and job completion demands may be high.
Must be able to remain in a stationary position more than 25% of the time.
Potential risk to lab-based hazards including but not limited to chemicals, biologicals, potent compounds, research material, high temperature, etc.
The person in this position needs to occasionally move inside and outside labs.
Frequently use objects, tools or controls, which will require regular bending, squatting, stretching and reaching in order to perform in a service function.
Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument/equipment), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
Employee may be required to handle hazardous wastes according to local, state, and federal regulations.
Recommended Skills Api Assessments Automation Biology Chemical Engineering Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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