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Senior Scientist - Analytical

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Aug 12, 2022

View more

Sector
Science, Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
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The Senior Scientist - Analytical progresses analytical aspects of projects, utilising their technical expertise in drug product and/or drug substance analytical development, as part of a PDS team and wider matrix teams. Conduct duties as listed below plus any other tasks as requested by team leader or departmental director. Additionally, the Senior Scientist - Analytical may perform quality control testing may approve quality control results, as applicable.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Independently executes analytical method development and validation experiments appropriate to phase and in line with QbD approaches, based on protocols.
  • Independently performs analytical work in accordance with protocols, and batch analysis requirements as appropriate, operating a range of laboratory equipment independently. Performs analytical testing and approve analytical results to support development and/or release or rejection of intermediate, bulk and finished product and/or release or rejection of starting materials, intermediates and drug substance and/or stability testing.
  • May oversee contract analytical testing and approve analytical results, as applicable.
  • May act as system owner for analytical equipment, as required, defining and/or organizing validation, calibration and maintenance activities and performing change control activities
  • Writes specific technical sections of internal and external reports with limited supervision. Prepares brief oral or written summaries of results with interpretation and recommendation for appropriate next steps .
  • May be responsible for significant aspects of analytical transfer as it relates to the drug product and/or drug substance process within/ between R&D and PSC.
  • Fully understands the requirements and follows the practices related to Quality, Safety and Regulatory aspects of their work
  • Complies with local data integrity requirements and may take a leadership role for data integrity projects. Attention given to data quality, integrity and archiving for own work and of others. Demonstrates timely and reliable recording of laboratory data in accordance with company policy and legal requirements.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS in Chemistry or science related degree with 5+ years of relevant experience, or MS in Chemistry or science related degree with 0+ years of science related experience
  • Demonstrated technical expertise and working familiarity with several analytical techniques and laboratory procedures


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Knowledge of how to analyze and interpret experimental data.
  • Knowledge of cGMP requirements
  • Awareness with FDA/EU/UK and ICH regulations and guidance related to analytical transfer and validation and release and stability testing.
  • Experience with laboratory systems (e.g. Waters Empower CDS and Labware)
  • Experience with both small molecule and biopharm analytical development.
  • Experience with analytical separation techniques (HPLC, uHPLC, GC, LC-MS, CGE, or cIEF )
  • Strong technical writing skills for documentation.
  • Excellent communication skills to collaborate well with others in the group and across groups.


Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant 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 isambitious 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.

*LI-GSK

#CMCDevelopmentGSK

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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