Senior Manager, Stability

Company: GlaxoSmithKline
Location: Cambridge
Posted on: January 26, 2023

Job Description:

Site Name: Cambridge Binney StreetPosted Date: Jan 18 2023Let's build a healthier world togetherWe make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.Reporting to the Director of QA Compliance, this position provides the opportunity to work directly with QC and regulatory staffto manage oversight of stability studies for vaccine products and data submission to regulatory agencies (Cambridge, MA).Key responsibilities

• Function as the QA lead for stability program management for Clinical and Commercial products
• Review and approve stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations
• Review stability sections for regulatory submissions
• Assignment and continuous monitoring of product shelf life
• Assist with updating and approving product specifications based on stability data
• Approve investigations related to temperature excursions, delayed or missed stability testing
• Approve investigations related to adverse trends in stability data (OOT or OOS)
• Maintain audit readiness of the stability program
• Assist with review and approval of qualification reports for analytical assays and critical reagents used to support stability studies, as neededWhy you?Basic Qualifications:you are and what you bring to the team---
  • Bachelor's degree (or higher) in Chemistry, Biology, Engineering, or related field
  • 7+ years of industry experience for a biopharma company
  • Experience with Good Documentation Practices
  • Experience with vaccines/biologics preferred
  • Able to think through the process and accurately apply and adapt regulatory standards
  • Able to respond to changing priorities and expectations with a composed demeanor and foster effective cross-functional relationships
  • Excellent communication, writing and presentation skills for interfacing with internal and external organizationsPreferred Qualifications & experience
    • Pursue tasks with energy, drive, and initiative; even in a fast-paced environment
    • Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure#GSKBinneyStreet #GSKAffinivax#LI-GSKWhy GSK?We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We're 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. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - 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's 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're 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.At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ AgenciesGSK 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's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting site.

Keywords: GlaxoSmithKline, Cambridge , Senior Manager, Stability, Executive , Cambridge, Massachusetts