Team Leader/Associate Director of Cell Based Bioassay

1 month ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Aug 2 2024

We are looking for a Team Leader/Associate Director in the Bioassay group, within the Structure & Function Characterization department in GSK. This is an exciting opportunity for the ideal candidate to lead a talented team of scientists contributing to the delivery of new medicines to patients. If you are an enthusiastic scientist who is eager to unite science, talent, and technology together, this may be the right opportunity for you.

The candidate for this role will provide comprehensive scientific leadership in the development, validation, and transfer of cell-based bioassays which reflect the proposed mechanism of action of our diverse therapeutic portfolio. These bioassays are used to support GMP release and stability testing, as well as characterization of pre-commercial drug substance and drug product materials.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
  • Lead the design and development of cell-based bioassays based on the understanding of biological mechanism of actions (MOA) of the product and early research & pre-clinical development knowledge.
  • Manage a team of scientists to support the development, fit-for-phase validation, transfer and life cycle management cell-based bioassays which are used for the characterization, comparability assessment & GMP release and stability testing of protein therapeutics, ADCs and potentially other modalities.
  • Coordinate with both internal and external stakeholders to manage resources and timelines on assay development, fit-for-phase validation, and method transfer to both internal and external GMP testing laboratories,
  • Interact with biology SMEs to influence the understanding of MOA and establishment of cell-based methods that can be used to support clinical development and commercial including testing in a GMP setting.
  • Provide guidance on compliance activities associated with the GMP testing environment including instrument validations, deviations, and change controls.
  • Manage the performance of staff members and help establish development plans.
  • Coach staff members to achieve their full potential; leading & motivating staff to meet both their individual and business goals.
  • Accountable for safety and quality standards which are consistent with company policies.
  • Develop and maintain good relationships both within and outside of the Analytical Development group.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Ph.D. in biological sciences with 5+ years of experience or a Master's degree with 10+ years of experience in the development of cell-based assays representative of biological MOA including antibody Fc effector functions..
  • Experience working with different cell systems in the development of bioassays for developing therapeutics in oncology, infectious diseases and/or other therapeutic areas.
  • Experience in method development and fit-for -phase validation based on relevant ICH guidance and regulatory expectations.
  • Experience troubleshooting various cell-based methods including but not limited to ADCC, ADCP, proliferation and reporter assays.
  • Experience supervising individuals or a team including a matrix team.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience in bioassay development from early development through approval and product launch including communication with regulatory authorities on overall potency strategies.
  • Active participation and/or leadership role in external professional and scientific organizations, exemplifying technical leadership in bioassay.
  • Experience in contributing to technical reports and regulatory submissions.
  • Strong track record of leading and influencing cross-functional teams, supervisory experience, excellent communication and interpersonal skills.
  • Knowledge and/or experience in Quality and Compliance in a pharmaceutical/biotech setting
  • Experience with cell-based methods for the development of oligonucleotide therapeutics
  • Experience with automation for cell-based assays (i.e. Hamilton, HP D300e).

#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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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