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Investigator, CMC Analytical Outsourcing Lead

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Oct 11, 2022

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Are you seeking an opportunity where you can grow your contributions to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this Investigator, CMC analytical outsourcing lead role could be an exciting opportunity to explore.

This role will provide YOU the opportunity to contribute to analytical development and to progress YOUR career. Your responsibilities include some of the following:

  • Act as analytical outsourcing interface with the wider CMC Project Team
  • Provide overall leadership for and direction for analytical work packages supporting API and Drug Product development carried out externally at CRO/CMO, including:
  • Monitoring any contract analytical testing


  • Proposing and approving validation protocols, reports and data for analytical methods.
  • Proposing and reviewing informal and formal stability studies and reports at CRO.
  • Developing and proposing specifications.
  • Proposing and reviewing degradation studies at CRO and reconciling against agreed genotox risk assessments.
  • Approving analytical test results to support release of starting material, intermediate and API for drug substance development and intermediate, bulk, and finished products for drug product development.
  • Coordinate the Analytical activities of the external team and raise issues if necessary with project teams
  • Contribute to regulatory submissions and internal governance documentation
  • Engage and assess supplier proposals against project requirements and make sourcing recommendations with R&D procurement
  • Act as externalization SME, sharing best practices in the technical lines
  • As a Third Party Oversight (TPO) Lead for specific Third Party Contractors (TPC), understand and influence the Quality & Safety culture and Technical capabilities of the TPC, identify continuous improvement opportunities, and decrease the risk associated with externalization of MDS activities.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS in Chemistry, Biology, or related discipline with 7+ years of pharmaceutical CMC development experience
  • Knowledge and understanding of cGMPs and regulatory requirements


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience with analytical laboratory data systems.
  • Expertise in negotiation and influencing
  • Experience in Project Management, managing the development and analytical delivery elements associated with External CRO/CMO activities
  • Demonstrated team working skills, working across boundaries, and sharing resources
  • Demonstrated technical expertise and knowledge of analytical techniques and laboratory testing procedures
  • Experience in the authoring of regulatory documentation
  • Ability to lead through the matrix and mentor inexperienced staff member
  • Excellent communication skills to collaborate with others within the project team and across different functional lines.
  • Strong technical writing skills for documentation.


Why GSK?

Uniting science, talent, and technology to get ahead of disease together

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 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 - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals 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 thisexciting moment in our journey. Join our challenge to get Ahead Together.​

GSKBiopharm_Development

*LI-GSK

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