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