Senior Scientist, Upstream Processing

Are you interested in directly supporting Clinical Drug Product manufacture while working on projects and assignments where independent action and a high degree of initiative and knowledge are required? If so, this Senior Scientist role within Biopharm Upstream Processing could be an exciting opportunity to consider. Job Purpose As a Senior Scientist within the Upstream Processing Team you will lead the Upstream manufacture of clinical supply of investigational biopharmaceutical molecules while supporting the technology transfer process through active participation in ensuring that new processes fit and execute consistently Responsibilities 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 Executes and oversees 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 Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take action to solve or prevent problems 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), Investigation reports, Safety Assessments, and various other protocols with minimal supervision Reviews and approves 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 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 Maintains and performs compliance checks for documentation in 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 Schedules all day to day tasks including preventative maintenance, calibrations, and validation with appropriate teams Provides training and guidance to less experienced manufacturing associates Serves as Subject Matter Expert (SME) in small scale, media preparation, or large scale operations Represents the group during cross-functional initiatives Serves as floor lead during preparation and processing activities and potentially as area Supervisor, in the absence of the Supervisor Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary Basic Qualifications Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field with 3+ year(s) of direct GMP manufacturing experience or upstream processing experience Preferred Qualifications Master’s Prepared Thorough knowledge of Good Manufacturing Practices (GMP) regulations 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 Possess in-depth knowledge of how to analyze and interpret experimental/process data Ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment Why GSK GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We aim to impact the health of billions of people and are committed to equal opportunity in employment. Accessibility and Equal Opportunity GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at View phone number on click.appcast.io (US Toll Free) or View phone number on click.appcast.io (outside US). If you are a US Licensed Healthcare Professional or Healthcare Professional as defined by law, GSK may capture and report applicable information in accordance with Transparency requirements. For more information, please visit GSK’s Transparency Reporting site. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies must obtain prior written authorization before referring candidates to GSK. #J-18808-Ljbffr GSK