Senior Scientist I II, Analytical R&D (Stability Coordinator)

About the team: 

The Analytical Development group within the Targeted LNP (tLNP) CMC Team at AbbVie is dedicated to advancing state-of-the-art analytical capabilities for mRNA-lipid nanoparticle therapeutics. Our team provides critical support across drug substance (DS) and drug product (DP) manufacturing drug product formulation and the development and implementation of robust analytical methodologies to ensure the quality safety and integrity of tLNP genetic medicines. We leverage advanced biophysical separations and mass spectrometry techniques to deeply characterize intact LNP particles. We foster close collaborations with cross-functional colleagues in CMC drug product formulation and external partners and are currently growing a world-class team of scientists who will be instrumental in building and deploying the analytical toolbox necessary to deliver high-quality innovative tLNP medicines to patients.

Position Description: 

AbbVies Targeted LNP (tLNP) CMC Analytical Development group is seeking a Stability Coordinator to oversee the release and stability programs supporting clinical development of mRNA-LNP this role you will coordinate all aspects of stability testing with external CDMOs and internal teams ensure the integrity of routine product release and stability data lead investigations and coordinate technical troubleshooting when analytical issues arise. Additionally the candidate must be able to foster productive collaborations within the global Analytical CMC organization and with R&D cross-functional partners such as Discovery Pre-Clinical Safety Process Chemistry Process Engineering Drug Product Development and Quality Assurance and CMC-Regulatory. 

Responsibilities:

• Serve as the primary point of contact for stability and release testing of tLNP drug substance and drug product at external CDMO partners.
• Manage and monitor routine release and stability studies for DS and DP including review of assay performance.
• Lead investigations into out-of-specification or atypical stability or release results; provide analytical troubleshooting coordinate confirmatory testing and drive root cause analysis.
• Compile and trend stability data contributing to shelf-life assignments comparability studies and regulatory filings.
• Collaborate with analytical method owners QA Regulatory and external partners to identify communicate and resolve analytical method and data issues.
• Track record of continuous improvement in analytical or stability programs such as driving assay harmonization implementing new technologies or increasing efficiency and compliance.
• Strong project management capabilities including timeline planning risk mitigation and proactive communication with internal and external stakeholders.
• Embraces the ideas of others nurtures innovation and manages innovation to reality.
• Raises the bar and is never satisfied with the status quo.
• Understand and comply with AbbVie safety quality and regulatory policies and government regulations. 

Qualifications :

• Senior Scientist I: Analytical Chemistry degree (or related field). BS with 10 years MS with 8 years and PhD with 0 years industry experience. 
• Senior Scientist II: Analytical Chemistry degree (or related field). BS with 12 years MS with 10 years and PhD with 4 years industry experience. 
• Demonstrated experience working with or managing CDMOs for analytical or stability programs.
• Direct experience overseeing stability programs for advanced biologics (oligonucleotide or nanoparticle-based products preferred).
• Demonstrated expertise in protocol design data trending and evaluation shelf-life justification and authoring CMC regulatory documents related to stability.
• Proven ability to manage outsourced analytical work including change control deviation investigations and oversight of method/technology transfers at CDMOs or contract labs.
• Hands-on familiarity with LIMS (Laboratory Information Management Systems) electronic lab notebooks and data integrity principles (Sample Manager preferred).
• Demonstrate creative out of the box thinking to solve difficult problems
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time