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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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