• Job Description

  Req#: 378582

  GSK is currently looking for an Associate Director, MSAT for our Manufacturing Science and Technology (MSAT) department to join our team in Cambridge, MA. In this role you will serve as the DS lead for our new MAPS vaccine product manufactured at the Cambridge site. We are looking for a team player with expertise in process development, process scale-up, technology transfer and GMP manufacturing with strong problem-solving skills and passion for leading and mentoring.

  Key Responsibilities:

  • Lead and manage technical activities for one of the next-generation vaccine programs, including product Lifecycle Management (Technical Risk Assessment, Product Control Strategies, Continued Process Verification), Technical Transfer.
  • Provide technical leadership for the rapid resolution of technical issues and deviations impacting supply and product performance investigations using root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate to key stakeholders for timely resolution.
  • Lead and manage Technology Transfers including authoring appropriate documentation package (facility-fit assessments, process risk assessments, process performance reports)
  • Provide technical support of cGMP manufacturing including identification and implementation of process improvements.
  • Analyze manufacturing performance through data review and analyses. Establish and maintain data repositories.
  • Maintain process information, documentation of process parameters, and tracking process performance.
  • Lead cross functional troubleshooting and operational improvements for manufacturing.
  • Ensure technical documentation is accurate and updated appropriately.
  • Author source documents for regulatory filings.

  Why you?

  Basic Qualifications:

  We are looking for professionals with these required skills to achieve our goals:

  • Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area
  • Bachelor of Science degree with 10+ years, Master’s degree with 8+ years or Ph.D. degree with 6+ pharmaceutical or biopharmaceutical experience.

  Preferred Qualifications:

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

  • Basic knowledge of statistical software is preferred.
  • Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
  • Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
  • MicrosoftÒ Word, Excel and Project experience required.
  • Experience with commercial manufacturing and cGMPs regulations

  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 Get Ahead Together.

  #LI-GSK

  Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

  Why Us?

  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 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.

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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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