Associate Directory, Biopharm Bioanalysis Cro - Collegeville, United States - GSK

GSK
GSK
Verified Company
Collegeville, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Site Name:
USA - Pennsylvania - Upper Providence


Posted Date:
Apr

Are you looking to combine your biopharm bioanalytical knowledge and experience with good laboratory practices (GLP) to help drive discovery programs forward, ultimately helping patients across the globe?


As a DMPK biopharm bioanalysis Associate Director, you will have the scientific and technical oversight of biopharm bioanalysis performed by CROs in the support of non-GLP and GLP non-clinical Toxicology studies.

A key part of this role will be the transition of discovery focused non-GLP methods run in house into GLP methods run solely at CROs.


Responsibilities:


Working within the DMPK department, you will use your experience with ligand binding assay-based approaches to support GSK's portfolio deliverables through the oversight of outsourced LBA-based bioanalytical studies.

By working directly with GSK's contract research organization (CRO) partners, you will oversee all aspects of non-regulated and GLP ligand binding based bioanalysis for non-clinical toxicology studies.

This will include the transfer of discovery-type methods, CRO method development, full assay validation, and the subsequent implementation of the methodology in studies spanning a range of biopharm projects and non-clinical toxicology study designs.


Why you?:


Basic Qualifications:

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

  • BSc/MSc/PhD in chemistry, biochemistry or related discipline with 5+ years of experience in pharmaceutical industry bioanalysis.
  • Experience with labwith PK, ADA, and/or biomarker ligand binding assays and target engagement ligand binding assay development and study support.
  • Experience working within GLP guidance for the validation of ligand binding assays.
  • Experience as the liaison between sponsor and contract research organization, working and communicating between the entities to ensure studies are successfully completed.
  • Experience working across LIMS platforms to ensure proper study management and detail capture.

Preferred Qualifications:

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

  • Attention to detail and effective communication/documentation skills will be expected.
  • Ability to work with and interact with bioanalysis teams in the clinical GLP space to smoothly transfer nonclinical assays into that area.
  • Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence.
  • Highly motivated team player with a proactive attitude, excellent organizational skills, and a demonstrated ability to interact effectively within a multidisciplinary team are essential.
LI-GSK

Please visit GSK US Benefits Summary to 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.

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.


Important notice to Employment businesses/ Agencies


Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

This capture of applicable transfers of value is necessary to ensure GSK's complia
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