Process Development Scientist
- Missoula, MT
Site Name: USA - Montana - Hamilton
Posted Date: Sep 11 2020
As a Process Development Scientist you will 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.
The role 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 MPL or QS21 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.
- 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.
- 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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:
- Bachelor's Degree in Chemical Engineering, Chemistry, Material Science, or related scientific discipline.
- Experience with understanding the complex biological and chemical manufacturing processes and how they impact and define the product, and how they interface with associated equipment.
- Experience with GMP, GLP, Process development, scale-up, and qualification.
- Experience with Chemical and physical processes like extraction, homogenization, and microfluidization.
- Experience with Physical separation processes like chromatography, filtration, UF/DF, etc.
- Experience with Basic analytical techniques like UV/Vis, pH, particle size, etc.
If you have the following characteristics, it would be a plus:
- Master's' Degree in Chemical Engineering, Bio engineering, or related scientific/engineering discipline.
- In-depth understand complex biological and chemical processes and how they impact and define the product, and how they interface with associated equipment.
- Experience with applying engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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