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Stability Manager, R&D Consumer Health

Company: GSK
Location: Richmond
Posted on: February 25, 2021

Job Description:

The GSK Consumer Healthcare R&D team supports the development of leading global brands in Consumer Health care. Stability sciences is a specialized discipline providing support for to new product development and product optimizations contributing to the growth of the Consumer Health Business. Their expertise is utilized by providing technical data supporting product stability within assigning shelf life and storage conditions.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:


  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

    The role requires close collaboration with Quality, Regulatory, Packaging and Product Development teams to ensure that technical data and documentation generated by Stability function meets the timeline and compliance.
    This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

    • Serve as Subject Matter Expert on multiple new product development project teams and provide guidance regarding stability regulations
    • Ensure that stability aspects of new products and product optimizations are assessed, reviewed and maintained throughout all development phases
    • Design stability strategies with consideration to meet global market requirements and regulatory guidelines (i.e. ICH/WHO). This includes design stability protocols for registration/ pivotal, In Use, Photostability, Bulk Stability, and Freeze Thaw/High Temperature stability studies
    • Proficient in LIMS or equivalent system to create and initiate stability protocols
    • Review of stability data to confirm expiry/shelf life support human use studies (i.e. sensory/clinical) to commercial launch and alerts project development team as appropriate
    • Utilize data analysis and sound scientific rational to establish expiry periods. Proficient in trend analysis using statistical software
    • Prepare documentation of trend analysis reports, and stability summary reports for regulatory submission (3.2.P.8 sections)
    • Confirms atypical and/or out of specification (OOS) results and participate in product investigation by applying root cause analysis and implementing effective CAPAs
    • Develops strong, collaborative relationships with outsourced partner to help facilitate completion of external Stability activities
    • Maintain awareness of global regulations that impact stability
      Why you?
      Basic Qualifications:
      We are looking for professionals with these required skills to achieve our goals:

      • Bachelor's Degree (Analytical Chemistry preferred)
      • 5 + years experience in the area of stability science, analytical chemistry within the pharmaceutical industry
      • Experience with and a thorough understanding of the drug development process with a diverse product experience including registered and monograph drugs, medical devices, dietary supplements, cosmetics and foods
      • Experience and knowledge of ICH/WHO and other stability guidelines
      • Experience working directly in stability program within the pharmaceutical industry
      • Experienced proficiency using LIMS (equivalent), Statistical software (i.e. Statistica/Minitab) Microsoft PowerPoint, Project, Word, Excel

        Preferred Qualifications:
        If you have the following characteristics it would be a plus:

        • Masters or PhD Degree
        • Solid awareness of cGMP guidelines
        • Excellent written and oral communication skills, ability to work well with others
        • Able to interact effectively with the most senior levels of management both internally and externally
        • Ability to multi-task and adapt to changing business requirements in a fast- paced environment.
        • Strategic planning and quick decision-making skills to meet timely organizational goals
        • Proven ability to express problems / challenges and solutions in a clear and concise manner
        • Strong understanding of stability study structure and managing stability chambers
        • Proven ability to successfully manage teams across time zones and cultures

          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/ Agencies
          GSK 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.PI130530801

Keywords: GSK, Richmond , Stability Manager, R&D Consumer Health, Healthcare , Richmond, Virginia

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