Process Development Scientist
Site Name: USA - Montana - Hamilton
Posted Date: Feb 4 2023
GSK is currently looking for a Process Development Scientist to join our team. In this role, you will focus on the Process Science section in MSAT, whose primary purpose is to carry out laboratory studies using small scale manufacturing models to support root cause investigations and evaluate process improvements. More specifically, this role involves the following:
- Execute a wide range of experiments independently and proactively incorporate new technologies or techniques into practice. Initiate new research directions and novel strategies to achieve “project” or department goals.
- Effectively perform process development, process characterization, process scale-up, process technology transfer, process troubleshooting, process optimization, process robustness, continuous process improvement and process validation of Bulk immunostimulants or other manufacturing process.
- Provide technical support to GSK contract manufacturing organizations (CMO) to facilitate/troubleshoot existing manufacturing projects.
- Implement and maintain a scientifically current, state-of-the-art laboratory environment.
- Operate a range of laboratory equipment independently.
- Develop operating process of the following unit operation as needed: chromatography, fermentation, extraction from biological matrices, product recovery filtration techniques; ultrafiltration and diafiltration, pasteurization techniques, lyophilization, microfluidization and other formulation techniques.
- Comply with GMP-GLP, cGMP, FDA/EMA regulation, quality systems, and other regulatory standards.
- Ability to take initiative and work proactively with creative problem-solving skills, implementing strategies for completion of investigation, troubleshooting process variability, and troubleshooting remediation.
- Collaborate with teams/division within the GSK organization to share relevant scientific information regarding the ongoing development projects and manufacturing processes.
- Coordinate the efforts of technical and scientific staff to achieve project objectives and milestones.
- Independently prepares and communicates conclusions and recommendations for next steps, to “project” members.
- Lead and manage projects related to manufacturing process improvement within GSK using the project management methodologies.
Environment Health & Safety:
- Perform routine laboratory inspections to comply with Environment Health and Safety (EHS) and Process Safety Management (PSM) policies.
- Maintains laboratory areas in a clean and safe manner.
- Work with colleagues to create a safe environment for all to use.
Quality & Compliance:
- Complies with cGMPs, PSM and EH&S safety policies and procedures as assigned.
- Independently writes specific technical sections of internal and external reports, publications, development reports, or regulatory documents.
- Proactively seek assistance from other scientists to solve problems.
- Anticipates/recognizes potential problems with equipment and/or supplies and initiates action to solve or prevent problems.
- Proactively incorporates new technology or techniques into practice following supervisor approval and direction.
- Training and records upkeep.
- Maintain assigned laboratory equipment and management systems.
- Write specific, easy to read documentation of projects in lab notebooks, demonstrating data integrity of ALCOA+ principles. Data must be complete and available to support relevant written documents.
- Strong communication skills (written, verbal, and presentation).
- Excellent lab practices, organizational skills, time management skills with the ability to work with multiple projects.
- To support development or characterization of bulk immunostimulants (MPL or QS21) or other manufacturing processes.
- Process characterization, process scale-up, process technology transfer, process troubleshooting, process optimization, continuous process improvement, and process or equipment validation.
- Hands on experience or understanding in unit operations of chromatography, fermentation, extraction, product recovery, filtration techniques, ultrafiltration, diafiltration, lyophilization, microfluidization, and other formulation techniques.
- Produce clear laboratory notebook records of experiments and projects, following appropriate data integrity principals and good documentation practices.
- Ensure a validated and robust process.
- Document and communicate plans, status, and results of projects in written reports and presentations, including the analysis and interpretation of data.
- Develop improvements to process efficiency and secure future production.
- Evaluate biological and process suitability of raw materials.
- Assess new technologies in aiming to approve processes or process techniques.
We are looking for professionals with these required skills to achieve our goals:
- BS Degree in Chemical Engineering, Chemistry, Material Science, or related scientific discipline.
- GMP, GLP experience
- Experience in physical separation processes like chromatography, filtration, UF/DF.
- Experience in basic analytical techniques like UV/Vis, pH, particle size.
If you have the following characteristics, it would be a plus:
- Master’s Degree
- Process development, scale-up, and qualification.
- Chemical and physical processes like extraction, homogenization, and microfluidization.
- Be capable of in-depth understand complex biological and chemical processes and how they impact and define the product, and how they interface with associated equipment.
- Ability to apply engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Get Ahead Together
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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