Investigator, Analytical Lifecycle Management

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Job description

Site Name: USA - Pennsylvania - King of Prussia, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence

Posted Date: Nov

As an Investigator - Analytical Lifecycle Management, you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business.

This role will provide YOU the opportunity to lead key activities to progress your career. These responsibilities include some of the following...

* Contribute to the implementation of business processes and best working practices to ensure Analytical Lifecycle Management operates strategically and as efficiently as possible.
* Independently authors internal reports, protocols, policies/plans or regulatory submissions.
* Supports department objectives in alignment with project objectives.
* Anticipates and recognizes potential problems, initiates actions to solve or prevent problems and communicates issues/risks to project lead and manager.
* Contribute to the successful and timely transfer, validation and oversight of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer's, testing labs, or GSK commercial manufacturing organizations (Product Supply Chain).
* Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills.
* May lead a project, matrix team or small focus groups.
* Plays a significant part in the project team decision making process.
* Consistently exhibits professionalism and courtesy and may serve as a representative of GSK to business partners and contract organizations.
* Presents effectively to internal R&D and PSC forums and may present results at external meetings.
* Keeps manager and matrix team leaders informed of progress and activities

Why you?

Basic Qualifications:

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

* Bachelor's degree in Biochemistry, Chemistry or Biology and at least 5 years Analytical Technology Transfer and Validation experience OR a Ph.D./MS degree in Biochemistry, Chemistry or Biology and at least 3 years Analytical Technology Transfer and Validation experience

Preferred Qualifications:

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

* Thorough knowledge of cGMP requirements.
* Previous experience in Analytical Technology Transfer and Validation for biopharmaceuticals.
* Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Transfer and Validation, Critical Quality Attributes, and Release and Stability Testing.
* Independently applies knowledge in area of specialization to assignments that involve multiple decision points.
* Familiar with GLP regulations.
* Previous Biopharmaceutical experience.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

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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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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