Job Description

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

Details (Your 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

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 with 3+ year(s) of direct GMP manufacturing experience or upstream processing experience

Preferred Qualifications:

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

• Master\xe2\x80\x99s 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 \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#LI-GSK

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

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 are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting site.

GlaxoSmithKline