Production Manager
Company: GlaxoSmithKline
Location: Rockville
Posted on: January 16, 2023
Job Description:
Site Name: USA - Maryland - RockvillePosted Date: Sep 27 2022The
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, functional
knowledge and experience, the ability to perform the activity
without guidance and teach others in the following areas:
- Knowledge of biopharmaceutical processes and equipment to
facilitate transfer of processes into production, data analysis and
identification and escalation of problems to the appropriate
support group.
- 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.
- Working with others to gain a win-win situation, using
persuasive communication, understanding influencing models,
negotiation, overcoming resistance.
- 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 explain and utilize techniques to improve and
sustain physical energy levels through the day to support
resilience on teams.
- Developing team capability to learn with knowledge of coaching
styles, listening and questioning techniques, feedback models and
emotional intelligence.
- Review all appropriate production documentation and insure GMP
compliance and metric attainment.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.
- 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.
- Knowledge and skill required to manage and use automation and
emerging digital platforms.
- 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
- 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 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.
- 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. -
- Recruit, hire and maintain appropriate staff levels to meet
operational and strategic goals.Why you?Basic Qualifications:We are
looking for professionals with these required skills to achieve our
goals:
- Bachelor of Science / Bachelor of Art in biological sciences,
chemical sciences, engineering or equivalent technical discipline.
- Degree in other discipline (or lack of degree) may be considered
if sufficient technical depth has been achieved from professional
experience.
- 7+ years of directly related experience manufacturing
experience in the pharmaceutical or biotechnology industry, with
the demonstration of a high level of performance and 2 years of
supervisory experiencePreferred Qualifications:If you have the
following characteristics, it would be a plus:
- Experience of the basic Federal Drug Administration (FDA) and
current Good Manufacturing Practices (cGMP) regulations.
- Strong verbal and written skills
- Required -to work various -and/or rotating shift structures
that may cover 24/7/365 operations"
- ---Ability to lift and carry materials up to 50 lbsWhy GSK?At
GSK, we have already delivered unprecedented change over the past
four years, improving R&D, becoming a leader in Consumer
Healthcare, strengthening our leadership, and transforming our
commercial execution. Now, we're making the most significant
changes we've made to our business in over 20 years. -We're on
track to separate and create two new companies in 2022: -New GSK
with a leading portfolio of vaccines and specialty medicines as
well as R&D based on immune system and genetics science; and a
new world-leading consumer healthcare company of loved and trusted
brands.With new ambition comes new purpose. For New GSK, this is to
unite science, talent, and technology to get ahead of disease
together - all with the clear ambition of delivering human health
impact; stronger and more sustainable shareholder returns; and as a
new GSK where outstanding people thrive.Getting ahead means
preventing disease as well as treating it. How we do all this is
through our people and our culture. A culture that is -ambitious
for patients -- so we deliver what matters better and faster;
-accountable for impact -- with clear ownership of goals and
support to succeed; and -where we do the right thing. So, if you're
ready to improve the lives of billions, join us at this exciting
moment in our journey. Join our challenge to get 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 , Production Manager, Executive , Rockville, Maryland
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