Senior Director, Analytical Research

BioSpace; North Chicago (IL); On-site; USD 180,000 - 280,000; Full time

Job summary

AbbVie is seeking a Senior Director to lead the Synthetic Molecule Analytical R&D organization across Lake County, US, and global sites. You will guide development and validation of analytical methods for diverse modalities, shaping strategies for drug substance, drug product, and formulation development from discovery through late-stage development.

The role requires steering cross-functional teams, driving innovative analytical technologies, and ensuring regulatory compliance while delivering

Qualifications

• PhD required with extensive pharma/biotech leadership experience.
• Masters with long tenure in pharma/biotech leadership also acceptable.
• Proven track record in analytical development leadership and cross-functional programs.
• Strong communication skills for senior leadership reviews and cross-site collaboration.
• Experience guiding regulatory compliance in pharmaceutical analytics.
• Entrepreneurial thinker with ability to drive innovations in analytical science.

Responsibilities

• Provide leadership for 50+ analytical scientists across sites in US and EU.
• Define and communicate industry-leading analytical strategies for complex modalities.
• Oversee development, validation and transfer of analytical methods globally.
• Establish analytical characterization to support process development and formulation design.
• Drive understanding of CQAs, degradation mechanisms, and interactions with excipients.
• Manage department budget, labs, and equipment; ensure timely delivery.

Skills

Analytical leadership

Cross-functional collaboration

Process development

Regulatory compliance

Communication skills

Education

PhD with 15+ years pharma/biotech experience

Master's degree with 20+ years pharma/biotech experience

Tools

Analytical methods

Method transfer

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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