Principal Scientist , Analytical Development Lead; tLNP CMC

Position: Principal Scientist I, Analytical Development Lead (tLNP CMC)
Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, ()  Facebook, Instagram () , X ()  and You Tube.

()

Job Description

The Analytical Development group within the Targeted LNP (tLNP) CMC Team at Abb Vie 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 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:

As an Analytical Lead within the Analytical Development team of Abb Vie's Targeted LNP (tLNP) CMC organization, you will be a cross-functional leader for scientific leadership in the development of advanced analytical methods to support tLNP characterization, process understanding, and product development. The successful candidate will independently develop innovative approaches and apply state-of-the-art electrophoresis and chromatography methods, serve as an analytical lead on development teams, and contribute to regulatory strategy and scientific innovation and coordinate testing with external manufacturing and testing organizations.  

This position also includes supervisory responsibilities, including leading and mentoring one or more scientists and supporting their performance and development.  Additionally, the candidate must 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 Affairs.

Responsibilities:

+ Effectively function as a principal research scientist, generating original technical ideas and research or development strategies.

+ Represent the tLNP Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross functional project teams.

+ Supervise a team of one or more scientists and be accountable for the performance of the team.

+ Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods. Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories.

+ Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, stability protocols/reports and method qualification/validation protocols.

+ Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.

+ Demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.

+ 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 Abb Vie safety, quality and regulatory policies and government regulations.

Qualifications

+ 12 (MS), or 6 (Ph.D.) years related industry experience.

+ Demonstrated expertise in analytical method development for biologics, with strong hands-on experience in characterization methods, capillary electrophoresis and HPLC.

+ Experience supporting biologics CMC development, QC method qualification/validation, and method transfer.

+ Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions.

+ Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions.

+ Ability to supervise and mentor other scientists; and to coordinate testing work at internal and external laboratories.

+ Working knowledge of data integrity, and compliance requirements for GxP-regulated bioassay testing.

+ Strong presentation and communication skills with the ability to explain data, controls, and risk assessments to technical and non-technical…