Associate Scientist, Upstream Operations

GSK•King of Prussia, PA

1d•Onsite

About The Position

This role supports laboratory and development activities that advance GSK's mission to get ahead of disease. The Associate Scientist will work with scientists, engineers, and technical staff to run experiments, analyze data, and document findings. GSK values curious, careful, collaborative people who learn quickly and communicate clearly. This position offers hands-on technical experience, opportunities for growth, and the chance to contribute to meaningful scientific work that affects patients worldwide.

Requirements

Bachelor’s degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field.
1+ year(s) of direct GMP manufacturing experience or upstream experience.
Experience with GMP regulations.
Experience working in a regulated environment following good laboratory or manufacturing practices.
Practical experience with standard laboratory techniques (pipetting, sample prep).
Experience following written procedures and maintain accurate lab records.
Experience with routine laboratory/plant equipment.

Nice To Haves

Prior exposure to laboratory information management systems or electronic lab notebooks.
Demonstrated problem-solving skills and experience with root-cause analysis.
Experience working on cross-functional projects or in collaborative research teams.
Strong written and verbal communication skills for clear documentation and teamwork.
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.

Responsibilities

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 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 regular safety and cGMP training and 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 in small scale, media preparation, and/or large-scale operations.
May be asked to serve as lead in the absence of area supervisor or senior scientist.
Provide support to the Safety Team and other EHS initiatives as required.
Assist with the manufacture of clinical supply of investigational biopharmaceutical molecules for use in early or late phase clinical trials.
Performs hands-on processing of large-scale cell culture or microbial fermentation 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 to resolve problems and make recommendations.