Posted on: January 26, 2023
Site Name: Cambridge Binney StreetPosted Date: Dec 19 2022Our
patients deserve bold, ambitious ideasWe 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 Site
Lead, GIO Binney Street, the Director, Head MSAT will be a member
of the GIO Binney Site Leadership Team. Functions within the scope
of the role are Manufacturing Science and Technology and Process
Validation. The Director, Head MSAT is responsible for establishing
the expertise and business processes in the MSAT and Process
Validation (PV) organizations to deliver robust and reliable
production processes which are designed, validated, and
commercialized to ensure continuous supply to patients. The
incumbent is accountable for providing technical support of
day-to-day GMP operations, setting strategies to maximize yield,
capacity, process robustness and reliability as well as fostering a
culture of continuous improvement and innovation to ensure the
supply of vaccines to patients. The role partners closely with
Process Development, Regulatory, EHS, Quality, Manufacturing and
Engineering / Facilities groups.Key Responsibilities
- Build an expert MSAT team and develop a highly engaged
organization with robust succession planning.
- Proactively promote positive Safety Culture and a cGMP
- (In association with Process Development), be accountable for
the successful process facility fit of MAPS Drug Substance to
commercial scale internal facility or other TT to CMO's using
robust risk management practices.
- Provide technical process leadership to manufacturing ensuring
systematic process understanding to support successful Phase 3, PPQ
and future commercial manufacturing.
- Partner with Manufacturing to ensure that Manufacturing
operations are set up for success through the provision of
high-quality batch records, robust processes, and new technology.
Anticipate, respond to, and resolve issues that arise during
production through use of master data, process & product
- Establish systems and procedures to enable proactive process
monitoring and analysis of manufacturing process data. Core
stakeholder to establish automation strategy for the site.
- Develop key performance indicators in conformance with license
requirements, cGMPs, regulations, site procedures which will
represent a state of compliance during Health Authority
inspections. Track and communicate manufacturing process KPIs in
real time throughout manufacturing campaigns as a mechanism of
driving a culture of continuous improvement.
- Leverage process expertise and continuous improvement
approaches to support process/operational deviations and
manufacturing investigations, owning impact assessment, supporting
data provision for true root cause identification, and supporting
timely close-out of investigations and corrective actions.
- Develop and draft study plans and protocols as required to
support regulatory requirements, deviations response, process
changes, raw material qualification etc.
- Promote innovation with respect to identification, evaluation
and implementation of new process technologies, new products,
troubleshooting complex issues or improvement to existing
commercial products throughout the product lifecycle.
- Be responsible for Process Performance Qualification (PPQ),
Continued (Ongoing) Process Verification (CPV/OPV) and Annual
Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs) during
- Author Sections of regulatory filings and support the review of
CMC part of regulatory submissions and Health Authority
- Represent MSAT on TDT(CMC) team and provide technical
leadership to drive alignment of critical decisions and risk
- Work with global MSAT to identify and implement timely delivery
of lifecycle management milestones.
- Support Procurement/Sourcing by providing technical expertise
for 'process fit' evaluations.
- Be accountable for overall budget and financial performance of
the MSAT organization.Why you?Basic Qualifications:
- A minimum of 15 years of experience in the early, late and
commercial phases of biopharmaceutical development and
- A minimum of 8 years of experience in the manufacture of
biologic molecules; vaccine and microbial fermentation production
- A minimum of 8 years of leadership experience.
- Must have prior experience in either design, qualification,
start-up or initial licensure of Biologics Manufacturing
- Must have prior experience with Tech Transfer facility fit,
process comparison gap assessment and mitigations
- Demonstrated evidence of deep process, equipment, automation,
validation, and technical knowledge.
- Thorough understanding and demonstrated experience with FMEA,
risk analysis, process characterization, process validation and
market application regulatory strategies for biologic
- Knowledge in CMC strategy, ICH guidelines, and regulatory
support tasks (IND, BLA, RTQ, and PAI).
- Extensive knowledge of quality systems, cGMP, regulatory and
industry standards at all phases of drug development.
- Understanding of, and experience with, global regulations
pertaining to cGMP manufacturing and analytical requirements for
Raw Materials, Critical Starting Materials, Drug Substance and the
translation of those regulations into process development, tech
transfer facility fit and commercial process design.
- Experience with statistics in the areas of statistical process
control, modeling, and data management.
- Computer skills (MS Office Suite, JMP or equivalent statistical
software, Visio, LIMS, SAP, etc).
- Proven ability to deliver results successfully, collaborating
with multi-cultural and geographically diverse teams.
- Demonstrated project leadership skills and the ability to
develop effective working relationships with internal and external
partners, direct/indirect reports, and cross-functional working
- Strong critical thinking skills and an ability to make
- The ability to foster a culture that embraces lessons learned
as a source of innovation to transform into future proactive
- Someone who acts as a change leader by visibly demonstrating
public commitment to change and aligning and helping others embrace
- Experienced at establishing clear directions, leading others,
and bringing out their best.
- Regular communication with peers/team members about corporate
strategy to drive awareness and build capability.
- The ability to communicate clearly and precisely, both orally
and in writing, is essential.
- High motivation, the ability to multi-task, prioritize, has
strict attention to detail and takes full ownership for successful
execution of tasks.
- May require up to 10% travel when necessary.Preferred
- A bachelor's Degree in Science/Engineering Related field,
Master's degree preferred.Why GSK?We're all driven by the same
powerful purpose, but it's this culture that powers our
performance, ensuring we achieve the challenge we've set ourselves
of getting ahead together. And it's by prioritising performance,
innovation, and trust that we continue to operate responsibly for
all our stakeholders and improve the lives of billions, every
day.#GSKBinneyStreet#LI-GSKGSK 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 , Director, MSAT, Executive , Cambridge, Massachusetts
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