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 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