Senior Director Biologics Analytical RD On-Site
Senior Director Biologics Analytical RD On-Site
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Job Description
Overview:
The Senior Director will be responsible for leading the global Biologics Analytical R&D organization supporting AbbVies neurotoxin pipeline which includes novel and genetically modified toxins paired with complex long acting and sustained release formulations for both aesthetic and therapeutic indications. He/she/they will lead the organization to drive the development of industryleading analytical methods analytical characterization packages and control strategies to advance neurotoxin programs from Discovery Research through latestage clinical development. The Senior Director will advance fundamental understanding of neurotoxin critical quality attributes (CQAs) excipienttoxin interactions and degradation mechanisms. He/she/they will partner crossfunctionally to drive robust drug substance and drug product manufacturing process development 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/they will drive toptier 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 neurotoxin drug substance drug product and novel drug delivery development. He/she/they 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/they will also partner with global Analytical R&D peer organizations working to advance other biologics modalities (mAbs Multispecifics ADCs Genetic Medicines) to benchmark strategies and technologies and leverage analytical best practices.
Responsibilities:
- Provide leadership and talent development for > 50 highlyskilled analytical and pharmaceutical scientists at the AbbVie Irvine CA site
- Defines and communicates industryleading analytical strategies for therapeutic neurotoxins
- Responsible for development validation and transfer of analytical methods aligned with the strategies
- Establishes industryleading neurotoxin analytical characterization capabilities to support process development formulation design and comparability
- Drives fundamental understanding of neurotoxin CQAs degradation mechanisms and toxin/excipient interactions
- Manages departmental budget analytical laboratories and equipment
- Balances resources resolves issues and achieves target timing for pipeline projects and key strategic initiatives
- 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.
- Manages and develops scientific talent across multiple disciplines and/or projects to address current and future business needs.
- Ensures scientific excellence and fosters functional scientific and professional development of staff.
- 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.
- Solves difficult and highly complex technical issues in an evolving regulatory climate.
Qualifications :
*This position is required to be onsite from our Irvine CA location*
- 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 biologics 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 to standard procedures is required.
- Solid understanding of the various scientific disciplines needed for therapeutic biologics 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.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
