Director, Biologics Analytical

AbbVie Product Development Science & Technology Biologics Analytical is a global analytical organization responsible for all CMC analytical activities related to the clinical development commercialization and on-market support of AbbVies biological products. Our scope includes AbbVies diverse pipeline of New Biological Entities (NBEs) including monoclonal Antibodies (mAbs) multispecific antibodies Antibody Drug Conjugates (ADCs) and gene therapies and spans from clinical development to commercial product support. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVies pipeline of innovative medicines and ensure the commercial manufacturing success.

The Director will be responsible for leading a diverse team supporting AbbVies pipeline which includes monoclonal Antibodies (mAbs) multispecific antibodies Antibody Drug Conjugates (ADCs) gene therapies and other biologic products. You will lead the groups to drive the development of industry-leading analytical methods and control strategies to advance pipeline programs from clinical development through commercial manufacturing. You will partner cross-functionally to drive robust development of drug substances drug products and combination products by enforcing rigorous risk management applying Quality by Design (QbD) and providing key analytical support and insights.

The 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. You will drive top-tier analytical method development and validation strategies implementation of new technologies and automation. You will establish collaborative and productive working relationships with key partner organizations to define successful process development strategies. The Director will effectively manage interfaces to ensure seamless transition of research programs into late-stage clinical development and technology transfers to commercial manufacturing and testing sites.

Major Responsibilities:

• Provides leadership strategic guidance and talent development for groups of highly skilled analytical and pharmaceutical scientists who are responsible for global development programs and commercial support across AbbVie global network.
• Defines and communicates industry-leading analytical strategies for mAbs multi-specifics ADCs and other potential new modalities.
• Familiar with commercial manufacturing and QC testing and able to be a partner in strategic initiatives in the commercial space for modernization of manufacturing and quality controls.
• Responsible for development validation and transfer of analytical methods to support pipeline development and product life cycle management aligned with the strategies.
• Establishes industry-leading analytical capabilities to support CMC process development technology transfer and post-approval changes.
• Solves difficult and highly complex technical issues in an evolving regulatory landscape.
• Balances resources resolves issues and achieves target timing for pipeline projects and key strategic initiatives.
• Ensures scientific excellence and fosters functional scientific and professional development of staff.
• Leads interactions with regulatory agencies in analytical development area and delivers regulatory filing packages.
• Manages and develops scientific talent across multiple disciplines and/or projects to address current and future business needs.
• Drives technical excellence and innovations in science that improve the capabilities and productivity of the organization.
• Works collaboratively across R&D and Operations to align and influence a broad range of development strategies that directly support drug development programs.
• Identifies evaluates and proposes both internal and external collaborations to drive scientific innovation and shared learning.
• Accountable for compliance with Environmental Health and Safety regulations for the group.

Qualifications :

• PhD with at least 10 years of relevant pharma/biotech industry experience or masters degree with at least 15 years of pharma/biotech experience.
• Proven experience leading a CMC development organization such as analytical development drug substance parenteral and/or combination products with a range of experience levels and scientific disciplines.
• Skilled in analytical method development validation transfer and troubleshooting for biologics. Familiar with extended characterization to evaluate critical quality attributes (CQAs) assess process changes and prove biosimilarity.
• In depth knowledge in relevant regulations interactions with regulatory agencies and deep NDA and BLA experience with major responsibilities.
• Extensive experience and solid understanding of the various scientific disciplines including analytical control strategies formulation development regulatory filings manufacturing Quality Assurance (QA) and supply chain.
• Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation.
• Track record on people management experience and leading matrix teams.
• Strong oral and written communication skills.
• Experience in motivating and maintaining positive morale of highly skilled technical individuals and teams in an environment where compliance with standard procedures is required.
• Strong negotiating influencing and leadership skills.

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 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 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time