349238 Production Supervisor, Senior
Company: GlaxoSmithKline
Location: Rockville
Posted on: January 17, 2023
Job Description:
Site Name: USA - Maryland - RockvillePosted Date: Jan 12
2023
- The Rockville Biopharm site exists to produce and deliver
biopharmaceutical drug substance of the highest quality in a safe,
compliant, reliable and cost-effective manner for our patients. Our
vision is to be wholly entrusted to make innovative, high quality
medicines by leveraging the best talent and technology, on a
platform of continuous improvement, to supply every patient, every
time.This role will provide YOU the opportunity to lead key
activities to progress YOUR career. These responsibilities include
some of the following:Possesses expertise and functional knowledge
of the following areas and ability to perform the activity without
guidance and producing quality results:
- Preparation, cleaning, sterilization, batching, pasteurization
or filtration and delivery of media and solutions for cell culture
and purification operations.
- Perform the set-up, operation, cleaning and break-down of
process equipment.
- Perform sampling procedures on various analytical instruments
to analyze cell culture, solution and/or product concentration
characteristics. Operate Filter integrity devices to confirm the
integrity of filters pre and post use.
- Set-up of fixed and mobile process equipment and parts with CIP
skids to carry out validated cleaning and sterilization
processes.
- Develop and follow appropriate standard operating procedures
(SOPs), protocols and batch records to safely perform process
operations and document compliantly with good documentation and
data integrity practices.
- Review all appropriate production documentation and insure GMP
compliance and metric attainment.
- Knowledge and skill required to manage and use automation and
emerging digital platforms.
- Knowledge of biopharmaceutical processes and equipment to
facilitate transfer of processes into Manufacturing, data analysis
and identification and escalation of problems to the appropriate
support group.
- Lead in the application of the GSK Production System (GPS)
continuous improvement system and apply the GPS mindsets and
behaviors in problem solving.
- Knowledge and experience with process operations, equipment and
instrument monitoring and trending to enable proactive
identification of issues to escalate and correct with applicable
departments.
- Ability to design tests and establish documentary evidence
demonstrating that a procedure, process, or activity carried out in
testing and then production maintains the desired level of
compliance at all stages. The collection and evaluation of data,
from the process design stage throughout production, which
establishes scientific evidence that a process is capable of
consistently delivering quality products.
- Knowledge and application of standard ERP processes in M-ERP
following global and local procedures.
- Comprehensive review of an organization or departments
adherence to regulatory guidelines and global corporate and local
procedures.
- A key management capability for mid to upper level management
that encompasses the ability to collaborate and build relationships
to define the organizational and business big picture (mission,
vision, strategic plan, etc.), anticipate the future and external
environment (competition, market, demand, etc.) and take strategic
action to establish a competitive edge and organizational
success
- Working with others to gain win-win situations, using
persuasive communication, understanding influencing models,
negotiation, overcoming resistance.
- Ability to choose a type of communication that is most
effective in a given situation.Such competency empowers individuals
to achieve the goals of any communication in a manner that is best
suited for all parties involved.
- The ability to provide strong teaching and facilitation skills
in training delivery to engage an audience to ensure that high
impact learning outcomes are reached.
- Ability to articulate production equipment and / or
manufacturing process problems to ensure accurate and detailed
communication.
- Transfers information to audiences of varying levels of
technical knowledge, so that each member of the audience clearly
understands the message.
- Follow all related safety policies and procedures and put
safety first by playing an active role in identifying and
correcting unsafe behaviors and conditions.Basic understanding and
knowledge of the following areas and ability to perform the
activity with some supervisory guidance:
- An appreciation of cultural differences and diversity in the
workplace.
- Build positive relationships with others and conduct
negotiation to establish win/win solutions.
- Developing team capability to learn with knowledge of coaching
styles, listening and questioning techniques, feedback models and
emotional intelligence.
- Recruit, hire and maintain appropriate staff levels to meet
operational and strategic goals
- Ability to explain and utilize techniques to improve and
sustain physical energy levels through the day to support
resilience on teams.Why you?Basic Qualifications: We are looking
for professionals with these required skills to achieve our goals:
- High School Diploma or GED
- 5+ years of directly related experience manufacturing
experience in the pharmaceutical or biotechnology
industry.Preferred Qualifications:If you have the following
characteristics, it would be a plus:
- Minimum of 2 years supervisory experience
- Understanding the of the basic Federal Drug Administration
(FDA) and current Good Manufacturing Practices (cGMP)
regulations
- Must exhibit GSK Values and Expectations
- Strong verbal and written skills
- Must be able to follow detailed processing instructions as well
as accurately documenting any necessary information
- Demonstrated ability to work effectively in a team
- Ability to work shifts that cover a 24/7 production
operation
- Ability to lift and carry materials up to 50 lbs
- Bachelor of Science / Bachelor of Art in biological sciences,
chemical sciences, engineering or equivalent technical
discipline.Why GSK?GSK is a global biopharma company with a special
purpose - tounite 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 organization 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 place where people feel
inspired, encouraged and challenged to be the best they can be. A
place where they can be themselves - 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 getGet Ahead Together.#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, Rockville , 349238 Production Supervisor, Senior, Professions , Rockville, Maryland
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