Senior Director, Analytical Research

BioSpace

North Chicago (IL)

On-site

USD 180,000 - 260,000

Full time

6 days ago

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Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Paid time off

Job summary

AbbVie North Chicago, IL seeks a Senior Director to lead the Synthetic Molecule Analytical R&D organization supporting early-stage pipelines across small molecules, peptides, ADCs, APCs, and LNP formulations, spanning discovery to late-stage development.

This role shapes analytical strategies, develops methods and control strategies, drives technology, and partners across R&D and manufacturing to enable robust drug substance, drug product, and delivery development in a fast-paced,

Qualifications

PhD with at least 15 years of pharma/biotech industry experience or master's with at least 20 years in pharma/biotech.
Proven leadership of an Analytical development organization across multiple disciplines.
Track record of leading strategic initiatives and evaluating/implementing new technologies.
Strong oral and written communication skills.
Experience motivating technical teams in a compliant environment.
Deep understanding of analytical, drug substance/product development, manufacturing, QA, and regulatory needs.

Responsibilities

Provide leadership for 50+ analytical scientists across sites in the US and Europe.
Define and communicate industry-leading analytical strategies for complex modalities.
Oversee development, validation, and transfer of analytical methods.
Develop analytical characterization capabilities to support process development and formulation design.
Drive understanding of CQAs and degradation mechanisms.
Manage departmental budget, labs, and equipment.
Ensure timely delivery of analytical deliverables within budgets and regulatory frameworks.
Collaborate across R&D and Operations to align development strategies with business goals.
Develop scientific talent across disciplines and projects.

Skills

Leadership

Analytical development

Strategic initiatives

Communication

Team development

Negotiation

Entrepreneurial thinking

Education

PhD in Chemistry/Biochemistry/Pharma science

MS with 20+ years pharma experience

Tools

Analytical methods development

Regulatory alignment

Job description

About AbbVie

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

Job Description

The Senior Director will be responsible for leading the Synthetic Molecule (SM) Analytical R&D organization in Lake County supporting AbbVie's innovative and unique early stage pipeline which includes small molecule, peptides, ADCs (antibody-drug conjugates), APCs (antibody-peptide conjugates), LNP (Lipid Nanoparticle), and future modalities paired with formulation development support for conventional (e.g. OSD, injectables) and complex formulations (e.g. Long Acting Injectables, co-formulations).

This individual will lead the organization to develop industry-leading analytical methods, analytical characterization packages, and control strategies to advance the manufacturing, purification, formulation, and process development for drug intermediates, Drug Substance and Drug Products from Discovery Research through late-stage clinical development. The Senior Director will advance fundamental understanding of novel synthetic modalities and their degradation mechanisms during manufacturing, shelf-life, distribution, and administration. He/she will partner cross-functionally to drive robust drug substance and drug product manufacturing processes and formulation selection by providing key analytical data and insights.

The Senior Director will ensure that all analytical deliverables are achieved within set timelines, budgets, and regulatory frameworks, while seamlessly integrating analytical and program strategies into broader business objectives. He/she will drive top-tier analytical method development and validation strategies, implementation of new technologies, and automation. The Senior Director will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies for drug intermediate, drug substance, drug product and novel drug delivery development. He/she will effectively manage Discovery Research and Operations interfaces to ensure seamless transition of research programs into clinical development and technology transfers to commercial manufacturing and testing sites. He/she will also partner with global Analytical R&D peer organizations working to advance similar Synthetic modalities to benchmark strategies and technologies and leverage analytical best practices.

Responsibilities

Provide leadership and talent development for > 50 highly skilled analytical and pharmaceutical scientists at the AbbVie Abbott Park, North Chicago, and Ludwigshafen Germany sites
Define and communicate industry-leading analytical strategies for complex modalities
Responsible for development, validation and transfer of analytical methods aligned with global strategies
Establish industry-leading analytical characterization capabilities to support process development, formulation design and comparability
Drive fundamental understanding of CQAs, degradation mechanisms and product/excipient interactions
Manage departmental budget, analytical laboratories and equipment
Balance resources, resolve issues and achieve target timing for pipeline projects and key strategic initiatives
Drive technical excellence and innovations in science that improve the capabilities and productivity of the organization.
Work collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs.
Manage and develop scientific talent across multiple disciplines and/or projects to address current and future business needs.
Ensure scientific excellence and foster functional, scientific, and professional development of staff.
Identify, evaluate, and propose both internal and external collaborations to drive scientific innovation and shared learning.
Accountable for compliance with Environmental Health and Safety regulations for the group.
Solves difficult and highly complex technical issues in an evolving regulatory climate.

Qualifications

PhD with at least 15 years of relevant pharma/biotech industry experience or master's degree with at least 20 years of pharma/biotech experience.
Proven experience leading an Analytical development organization with a range of experience levels and scientific disciplines
Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation
Strong oral and written communication skills.
Experience motivating and maintaining positive morale of highly skilled technical individuals and teams in an environment where compliance with standard procedures is required.
Solid understanding of the various scientific disciplines needed for therapeutic development (including analytical, drug substance development, drug product development, combination product development, manufacturing, QA, supply chain, regulatory).
Strong negotiating, influencing, and leadership skills
Entrepreneurial thinker capable of driving innovative ideas and making smart business decisions.

Team size: 50+

Number of programs supported: 20+

Recent additional responsibilities: peptides, LNP

Additional Information

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 long-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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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