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Director Biologics, Early Analytical Development

Employer
AbbVie
Location
Irvine, California
Start date
Feb 1, 2024

Job Details

The Director of Biologics, Early Analytical Development is responsible for collaborating with DS (Drug substance), DPD (Drug product development), Drug delivery, Discovery and other cross-functional teams to support new and innovative toxin drug substance and drug delivery development.  Support a team of scientists who will be involved in candidate screening and selection, developability assessment of novel and genetically modified neurotoxins, as well as technology scouting and developability assessment for innovative drug delivery technologies of neurotoxin programs (e.g. sustained released or enabling formulation), up to proof of concept and the initiation of clinical development.

 

The Director maintains a broad knowledge of established, emerging and highly innovative analytical tools and technologies. This role will utilize internal and external networks, and prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing outstanding analytical science to advance AbbVie’s biopharmaceutical/neurotoxin programs. The Director will lead groups of scientists engaged in supporting the next and future generations of the neurotoxin product pipeline through early phases and then transfer the science and technologies developed to the organization in charge of clinical trial supply CMC.  We are seeking an experienced leader who is ambitious in working with different types of biologics molecules and formulations and who is curious to develop novel and targeted analytical technologies and methodologies for the development of AbbVie’s future neurotoxin pipeline.  This position would support but is not limited to early development activities including lead optimization, candidate nomination, and candidate selection of novel and modified neurotoxins and enabling technologies by leveraging the entire portfolio of AbbVie’s current and future neurotoxins.  The focus of this position would be to support Neurotoxins and recombinant Neurotoxins in variety of different formulations, drug delivery vehicles (nanoparticles, sustained release, etc.) and presentations (such as lyophilized, liquid, injectables etc.).  Furthermore, this team will be responsible for developing, improving and optimizing analytical methods to enable GLP Tox and early clinical studies. The Director will contribute with a broader leadership team, assisting with Biopharmaceutical Development program review and assessment, as well as helping to set and achieve site objectives.. This individual will write, review, and approve documents of various types, including scientific reports and documentation for regulatory submissions, method qualification/validation protocols and reports, and policies. The Director takes a leadership role in setting strategic directions, assessing, and bringing new analytical capabilities into the organization, and ensuring that technical capabilities remain focused and current.  This candidate would be responsible for providing support for Biologics developability assessment and for establishing stability for novel neurotoxins or toxin/drug-delivery combinations.  His team will also be supporting analytical outsourcing activities, as needed.  The Director will ensure phase-appropriate assay development requirements are met, while having a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use.  This leader would support proper development and training of staff members and ensure regulatory and EHS compliance.

 

This position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

 

Key Responsibilities:

Strategic Leadership: Develop and implement a comprehensive assay development strategy aligned with the company's mission and objectives. Set clear goals and milestones for the assay development team.

Team Management: Manage a diverse and high-performing team of scientists, research associates, and project managers. Foster a collaborative and innovative work culture.

R&D Pipeline Management: Oversee the development of assays and testing platforms.  Ensure all, projects are executed on time and within budget. Actively review and adjust priorities, programs, and decisions to optimize delivery against the most value-generating aspects of AbbVie’s programs.

Innovation and Technology Assessment: Stay current with the latest developments in assay technologies (including highly innovative and targeted analytics) and identify opportunities for innovation and improvement in our product portfolio.

Regulatory Compliance: Ensure that all assay development activities adhere to relevant regulatory standards and guidelines, including but not limited to FDA, EMA, ICH etc.

Cross-functional Collaboration: Collaborate closely with other departments, including Biologics Discovery CMC, Drug Product Development, Drug Substance, Drug Delivery, Operations, Quality, Business and Clinical Development to ensure seamless product development.

Resource Allocation: Manage budgets, resources, and external partnerships to maximize the efficiency and effectiveness of the assay development process.

Adherence to current health authority guidelines and regulations: Implement procedures to ensure analytical team members are aware of current guidelines and procedures.  Assay development should be phase appropriate and Fit-for-Purpose to ensure quality and reliability of products.  .

Data-driven Product Development:
 Generate robust datasets, and interpret and make data-driven decisions with the participation of broader team to guide product development.

Intellectual Property Management:
Ensure the protection of intellectual property and the development of a strong patent portfolio.



Qualifications

Ph.D. in a relevant field (e.g., Chemistry, Molecular Biology, Biochemistry, Biotechnology), with a minimum of 8 years of experience in managing analytical development team.  Pharmaceutical industry experience is desirable but not necessary.

Proven track record of successfully leading teams in the development of robust analytical assay.

Proven track record in building and managing teams of highly skilled scientists and managers of various levels of experience.

A deep knowledge of neuroscience, therapeutic proteins and drug development across different biologics modalities.  Experience in working with gene and cell therapy is a plus.

Experience with mLD50, CBPA (Cell based potency assay), LCMS/MS and other separation techniques such as CE-SDS, SDS-PAGE, Western blot, SEC, AEX, CEX, Particle size analysis and other compendial methodologies is preferred.

In-depth knowledge of the various scientific and technical disciplines (and their integration) related to evaluating and advancing platform and therapeutic development.

Experience leading and working collaboratively on cross-functional project teams.

Excellent leadership and interpersonal skills, with the ability to communicate complex scientific concepts effectively.

Strategic thinker with a passion for innovation and a commitment to staying at the forefront of scientific advancements.


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 short-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 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 committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s 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.


Company

AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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