Drug Substance MSAT Leader

Detailed Information

LISTED SITE
  • Location: Marietta, PA

  • Company: GSK

This responsibility includes process transfer, process technology for drug substances, continuous improvement of drug substance processes, troubleshooting of drug substance processes, and life cycle management of drug substance products and processes.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Organize the drug substance and method transfer teams (including recruiting and hiring) and train and mentor team members. Lead the development and execution of drug substance transfer plans and the analytical method transfer plans. Cascade Marietta and project objectives, set objectives for the

drug substance and QC transfer workstream and manage performance to achieve the objectives. Deliver drug substance product stewardship through continuous process verification.

Lead the troubleshooting of drug substance products and processes. Develop change control and regulatory strategy that ensures that goals are delivered safely, compliantly, and on time. Coordinate with all departments, global functions, manufacturing units, and QC units to ensure that process transfer and QC transfer goals are achieved. Develop relationships with AR&D, TR&D, and global MSAT to ensure that Marietta product transfers, technology and product improvement projects, and life cycle improvements are prioritized

and delivered urgently and effectively. Ensure that all product and process documentation is complete and compliant with GMPs.

Represent Marietta in meetings, presentations, audits, and inspections. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in engineering or science 5+ years' experience in vaccine manufacturing Preferred Qualifications: If you have the following characteristics, it would be a plus: Process engineering Process validation Risk backssment Change management Documentation Team leadership Communication Presentations Report preparation Project management Regulatory inspection experience Hazard and operability studies (HAZOPs) 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#Marietta Vaccines#vaccinessupplychain#Marietta GSCPlease 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 -xyz X (US Toll Free) or xyz X (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, interaction, pregnancy, marital status, interactionual 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 For the Record site. PDN-9ad5d3e7-f4c8-45b4-a0ec-cf0b720b9212

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