An Associate Scientist Upstream Processing
- Executes production of clinical supplies based on established procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
- Anticipates/recognizes potential problems with equipment and/or supplies, and takes action to solve or prevent problems
- Recognizes potential safety and compliance problems and takes action to rectify or escalate
- Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and communicates to the appropriate decision makers
- Authors Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols with minimal supervision
- Reviews executed load documentation (washer and autoclave), Media Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
- Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost
- Documents work performed via the use of logs, media forms, batch records, and electronic systems in accordance with company policy and legal requirements
- Strives for Right First Time in the manufacture of investigational material through attention, focus, planning, and adherence to procedural and regulatory expectations
- Attends to regular safety and cGMP training: maintains accurate and complete safety and role-specific training records, consistent with company policy and legal requirements
- Provides training and guidance to less experienced manufacturing associates
- Serves as Subject Matter Expert (SME) in small scale, media preparation, or large scale operations
- May be asked to serve as lead in the absence of area supervisor or senior scientist
- Assist with the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically: hands-on cGMP large scale cell culture, viral vector manufacturing, or microbial fermentation for use in early phase clinical trials
- Performs hands-on processing of large scale cell culture or microbial steps under cGMP regulatory conditions. Processing steps include: Small scale/scale-up from vial thaw, end of production, media preparation, operation of stainless steel and single use bioreactors, harvest operations, CIP, SIP, washer and autoclave operation
- Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.
If you have the following characteristics, it would be a plus:
- At least 3 months experience with Good Manufacturing Practices (GMP) regulations
- Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary
- Strong organizational skills
- Excellent interpersonal communication skills
- Excellent technical writing skills
- Ability to work in multi-disciplinary and multi-cultural teams
- Ability to interpret analytical results from experiments to troubleshoot and optimize analytical methods
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.
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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