Production Manager
Company: GlaxoSmithKline
Location: Rockville
Posted on: May 26, 2023
Job Description:
Site Name: USA - Maryland - RockvillePosted Date: May 19 2023The
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.
- 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.
- 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 ensure 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 application of standard ERP processes in M-ERP
following global and local procedures
- Adherence to regulatory guidelines and global corporate and
local procedures.
- 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.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:
- 7+ years of directly related experience manufacturing
experience in the pharmaceutical or biotechnology industry, and 2
years of supervisory experience
- Requiredto work variousand/or rotating shift structures that
may cover 24/7/365 operations
- Ability to lift and carry materials up to 50 lbsPreferred
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
- Strong verbal and written skills
- 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 -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 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 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 positively impact the health of
2.5 billion people by the end of 2030.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.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
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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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