Associate Scientist , Upstream Processing

Are you interested in performing hands-on processing in a cGMP environment for use in early phase clinical trials? If so, this Associate Scientist, Upstream Processing position might be for you!

As Associate Scientist, you will be responsible for…

• Assisting with the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically: hands-on cGMP large scale cell culture or microbial fermentation for use in early phase clinical trials
• Performing 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
• Completing 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, working 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. These responsibilities include some of the following:

• Execute production of clinical supplies based on established procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
• Anticipate/recognize potential problems with equipment and/or supplies, and takes action to solve or prevent problems
• Recognize potential safety and compliance problems and takes action to rectify or escalate
• Troubleshoot problems in the execution of processing activities; proactively assesses options and impact and communicates to the appropriate decision makers
• Author Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols with minimal supervision
• Review 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
• Identify process improvement opportunities with impact on safety, compliance, and efficiency/cost
• Document work performed via the use of logs, media forms, batch records, and electronic systems in accordance with company policy and legal requirements
• Strive for Right First Time in the manufacture of investigational material through attention, focus, planning, and adherence to procedural and regulatory expectations
• Attend to regular safety and cGMP training: maintains accurate and complete safety and role-specific training records, consistent with company policy and legal requirements
• Provide training and guidance to less experienced manufacturing associates
• Serve 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
  

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
  
• At least 1+ year(s) of direct GMP manufacturing experience or upstream 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:

• Familiarity with Good Manufacturing Practices (GMP) regulations
• Operational knowledge of routine laboratory/plant equipment
• 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?

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

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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