Senior Scientist-2 Year Secondment
GSKAbout the role
Job Purpose:
- Strong team player with ability to efficiently coordinate activities with others.
- Able to follow laboratory procedures and processes in completing routine tasks and respond quickly and appropriately to unanticipated events.
- Good communication skills.
- Strong work ethic and high level of personal efficiency.
Job responsibilities:
- Coordinates and manufactures master and working cell banks to meet project timelines. Perform cell banking operations (manufacturing and stability assessments) following written procedures and master batch records in accordance with cGMPs. Duties include cell counts, cell passages, and environmental monitoring (EM).
- Coordinates the manufacture of cell banks at Contract Manufacturing Organizations (CMOs) including aspects of the process and material transfers, testing and release of the cell bank.
- Completes and maintains all assigned/required safety and role-specific training.
- Represents the department on cross functional communications, meetings and on teams (including MPD teams) and coordinate activities, as required.
- Serves as equipment owner, coordinating tasks such as calibration scheduling, submitting Work Orders (WO), and addressing any Out of Tolerances/Out of Services (OOT/OOS), as required.
- Authors, reviews, and executes documentation as applicable such as but not limited to, PTDs, MBRs, media forms, SOPs, WIs, and reports. Additionally, approve SOPs, WIs and reports in areas of expertise.
- Serves as point of contact for EM exceeded action limits (EALs), completes reviews to investigate possible root cause and complete necessary documentation.
- Coordinates and performs national and international cell bank shipments using liquid nitrogen shipper and evaluate temperature data post shipment for compliance.
- Maintains cell bank inventory, performs annual cell bank inventory checks, and supports transfer of cell banks to manufacturing, testing, and development groups.
- Participates in deviation investigations, implementation of Corrective and Preventative Actions (CAPAs) and Change Control (CC) actions, as required.
- Coordinates and performs monthly, quarterly, bi-annual, yearly and changeover activities including but not limited to equipment cleaning, logbook reviews and historical data reviews.
- Supports preparation activities and participates in GMP and safety audits, as required.
Basic qualifications:
- BS in relevant field (i.e. Biology, Chemistry, etc.) and 3+ years of applicable working experience.
- Knowledge of cell banking/cell culture.
- Knowledge of GMP requirements and documentation practices.
- Operational knowledge of laboratory/plant equipment.
Preferred Qualifications:
- Strong team player with ability to efficiently coordinate activities with others.
- Able to follow laboratory procedures and processes in completing routine tasks, respond quickly and appropriately to unanticipated events and provide suggestions for response and improvement.
- Good communication skills as well as solid scientific/technical knowledge base which facilitates communication.
- Strong work ethic and high level of personal efficiency.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 Ahead Together.
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