The Associate Scientist assists the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically, hands-on cGMP manufacture of mid to large scale purification of bulk drug substance for use in early phase clinical trials .
The key responsibilities of the role include the following:
- Performs hands-on processing of large-scale purification steps under cGMP regulatory conditions. Processing steps include: Column packing, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Bulk Drug Fill
- Executes and overseas production of clinical supplies based on established scientific procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
- Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns
- Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
- Performs cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods
- Prepares, assembles and sterilizes via autoclave of equipment and process components
- Prepares buffers, including weigh and dispense, formulation, and filtration activities
- In addition to manufacturing responsibilities, works on projects and assignments where independent action and a high degree of initiative are required in order to resolve problems and make recommendations
This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following:
Why you? Basic Qualifications:
- Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required for execution or to provide recommendations
- Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take action to solve or prevent problems
- Represent the group during cross-functional initiatives
- Serve as Subject Matter Expert (SME)
- Train and mentor less experienced manufacturing scientists
- Recognizes potential safety and compliance problems and takes action to rectify
- Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers
- Authors Standard Operating Procedures (SOPs), Safety Assessments, and various other protocols with minimal supervision
- Reviews and approves executed documentation, Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
- Leads deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations
- Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications :
- Bachelor's degree Chemical Engineering, Biology, Chemistry, or other engineering or scientific field OR 2-4 years of equivalent experience.
- Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary
- Experience in a Good Manufacturing Practices (GMP) environment
- Large-scale downstream manufacturing experience
- Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes
- Demonstrates good interpersonal skills, and communicates well both verbally and through written communications. Maintains a professional and productive relationship with area management and co-workers
- Ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
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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