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Associate Scientist - Upstream Manufacturing

Employer
GSK
Location
King of Prussia, Pennsylvania
Salary
Competitive
Closing date
Jun 1, 2022

View more

Discipline
Physical Sciences, Chemistry, Other, Manufacturing/QA/QC
Job Type
Staff Scientist
Organization Type
Pharma
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!

Click to know more about GSK Biopharm.

#GSKBiopharm_Development

The Associate Scientist assists 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.

Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary

The key responsibilities of the role include the following:
  • 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
  • Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns
  • 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:

  • 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
  • Provide support to the GMPO Safety Team(s) and other EHS initiatives as required


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.
  • 3+ months of direct GMP manufacturing experience or upstream experience
  • Experience working with Good Manufacturing Practices (GMP) regulations
  • Experience working in a routine laboratory/with plant equipment


Preferred Qualifications:

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

GSKBiopharm_Development

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