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Associate Director - Biopharm CQA Lead

Collegeville, Pennsylvania
Closing date
Jun 25, 2022

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We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients , join us!

Click here to know more about GSK Biopharm.


Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this Associate Director role could be an ideal opportunity to explore.

As a Associate Director, you will be responsible for providing in depth focus on due diligence evaluations for biopharmaceutical product sciences, and management and direction of Biopharmaceuticals Science staff across Biopharmaceutical Product Development (BPD) departments.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • A scientific individual contributor under the Team Director of Mass Spectrometry and Characterization.
  • Lead the identification and life cycle management of critical quality attributes (CQA) for protein therapeutics.
  • Sets and leads internal strategies aligning to changes in analytical technologies, regulatory expectation, and portfolio.
  • Works with candidate selection (CS) teams to understand potential CQAs (pCQAs) and knowledge transfer at CS
  • Interfacing and collaborating with other functional areas (e.g. Discovery, in vitro/in vivo Translation, and clinical teams) in a environment, to design suitable structure-function relationship studies including in vitro and in vivo studies to mitigate any potential CQA risk.
  • Supports continuous improvement in analytical technologies, product characterization strategies, innovation, and efficiency within the department
  • Providing leadership through effective feedback, coaching, mentoring, and training to influence cultural change to deliver the strategic priorities.

Why you?

Basic Qualifications:

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

  • PhD in Biology , Biochemistry, or related scientific field with minimum 5 years experience in biopharmaceutical development.
  • Experience in analytical methodologies used to characterize physiochemical properties, immunochemical and biological activity of protein therapeutics.
  • Experience of regulatory requirements as applied to QbD (quality by design) and CQA, and phase-appropriate analytical strategies.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience in leading identification and life cycle management of CQA from early development through commercial launch, and developing risk based, phase-appropriate analytical strategies.
  • Experience in analytical comparability, forced degradation and design of experiments for the understanding of structure function relationships
  • Experience in design and execution of structure function relationship studies including in vitro and in vivo studies linking product quality attributes to biological activities as a part of the CQA identification and analytical control strategy development
  • The ability to learn and apply CQA principles from monoclonal antibodies to novel modalities and remain current on scientific advances in CQA and QbD.
  • Experience in leading multidisciplinary teams or projects, driving milestone and project progression in dynamic and challenging environment. Demonstrated ability to influence stakeholders without direct line authority
  • Capability to efficiently prioritize and manage simultaneous deliveries to multiple projects,
  • Excellent leadership, communication, and interpersonal skills

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 geneticsscience; 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 diseasetogether - 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.​



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