Associate Manager Biologics AD (Bioassay)

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Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Biotherapeutics R&D

Job Category:
People Leader

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:

Position Title: Associate Manager Biologics AD (Bioassay)

Department: TDS-AD Cork

Report to: Associate Director/Manager, Bioassay and Advanced Therapy Stability Sciences

Travel: 5%

Global Compensation Framework Band Number: 26

Therapeutics Development & Supply, Analytical Development (TDS-AD) Cork, is a department responsible for the clinical release and stability testing of drug substance and drug product materials and stability management of the large molecule (therapeutic proteins) portfolio.

In addition to clinical release & stability activities, TDS-AD Cork is responsible for analytical support of large molecules through analytical method transfer, evolving method knowledge as part of the product lifecycle and investigations and manufacturing support.

This job description will outline the role of the Associate Manager Biologics AD who will be responsible for people leadership and talent development of a team of scientists that are responsible for the release and stability testing activities with particular emphasis on bioassays, identity and process impurity assays:

Position Summary:

Reporting to the Manager, Bioassay and Advanced Therapy Stability Sciences (TDS-AD) Cork, the person will be focused on the release and stability testing of the large molecule clinical pipeline and be responsible for the resolution of product related issues.

Given the diversifying of the Johnson and Johnson clinical portfolio, this may include a diverse class of molecules/entities including monoclonal antibodies, bis-specific antibodies, antibody drug conjugates and advanced therapeutic medicinal products (ATMP’s).

This individual should demonstrate technical leadership in analytical technologies and stability sciences and will represent the department on cross-functional and external teams and act as a technical expert.

Main duties and responsibilities:


* Manage the laboratory testing of clinical stability and release samples for the Bioassay Technology team.


* Drive and support a proactive safety culture within the Laboratory.


* Ensure laboratory activities are carried out in compliance with cGMP and appropriate regulatory standards. 


* Motivate and develop reports in addition to developing and se...