Associate Scientist - Downstream Operations

We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us!

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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:

• 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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree Chemical Engineering, Biology, Chemistry, or other engineering or scientific field OR 2+ years of GMP experience.
• Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

*LI-GSK

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