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
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