Your Responsibilities :
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients.
Our work spans all formulation types, novel technologies, and Advanced Manufacturing Technology for multiple modalities for small and large molecules through to Cell and Gene Therapy.
The Manager / Associate Director will lead key, strategic CMC regulatory activities for investigational and / or commercial biopharmaceutical (therapeutic protein and cell & gene therapy) products.
The successful candidate will :
About You :
This role would suit a self-motivated individual who can demonstrate initiative, high learning agility and adaptability.
You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance.
You will have a strong continuous improvement mindset.
The role would also suit an individual who has experience of working in a cross-functional, global supply organization. During the application process, we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
This role can be based in or Upper Providence, Pennsylvania, USA or Ware, Hertfordshire, UK this role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity.
Basic qualifications :
Preferred qualifications :
Why GSK? :
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments.
At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers.
On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-
877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity / Affirmative Action Employer. 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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