Associate Director, Immunogenicity and Ligand - London, United Kingdom - Moderna

Moderna

Verified Company

London, United Kingdom

1 day ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

The Role:

Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the Clinical Bioanalytical team to lead Immunogenicity and LBA-based bioanalysis under GLP/GcLP compliance.

A successful incumbent will provide Scientific and operational oversight of pharmacokinetic (PK), anti-drug antibodies, neutralizing antibody assays and routine biomarker bioanalyses for Moderna mRNA based therapeutic pipeline.

This role will be based at the new Moderna Innovation and Technology Centre in Harwell - the first Moderna research centre outside of the USA - and is an opportunity to join an exciting, dynamic, and expanding team.

Here's What You'll Do:

Leads the Immunogenicity and Ligand Binding Assays team and the design and execution of phase-appropriate clinical bioanalytical strategies, including quantitation of therapeutic proteins, immunogenicity (anti
- drug antibodies and neutralizing antibody assays) and PK/PD assay method development, validation and sample testing under GLP/GcLP regulations.

Establish LBA based GLP/GCLP regulated capability and facilitate method development and validation to support clinical programs.

Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities assuring phase appropriate approach.

Responsible for the development of cell based Nab assays and PD assays using ELISA, MSD, multiplex LBAs, and Gyro based protein assays, immunoblotting and other relevant technologies.

Responsible to ensure assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose in clinical use and troubleshoot any issues that arise internally or with external CRO partners

Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP's, determination, and control of critical reagents for example.

Assist in writing regulatory submissions and in responding to regulatory queries when needed.

Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.

Here's What You'll Bring to the Table:
A Ph.

D., or equivalent qualifications and experience, in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 7+ years of industry biotech/pharmaceutical experience in regulated bioanalysis.

Experience with RNA, biologics and cell therapy preferred

Expert knowledge of various ligand bind binding assay platforms such as ECL, Gyrolabs, cell based assays and other methodologies for pre-clinical and clinical assays is preferred.

Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.

Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.

We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission eve