Principal Research Scientist I - Biologics Analytical R&D at 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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Principal Research Scientist I is responsible for ensuring uninterrupted operations of testing facilities; overseeing inventory management and compliance with CDC requirements; ensuring departmental compliance with cGMP regulations; coordination of stability studies; overseeing all aspects of coordination of activities with PBL and analysis of mLD 50 data. Support a team of analysts who will be involved in day-to-day operations of the department.

The Principal Research Scientist I will lead groups of analysts engaged in laboratory support operations to ensure uninterrupted operation of all critical instruments, storage devices, stability chambers. This position will oversee inventory of select toxin samples including coordination of shipping and receiving of highly toxic compounds ensuring compliance with CDC regulations. This role will oversee coordination of development and GMP stability studies as well as compilation and traceability of all relevant analytical results. The Principal Research Scientist II will ensure departmental compliance with cGMP requirements, will lead method validation activities and any relevant investigations/audits associated with QC activities of the department. This position will coordinate mLD 50 testing at PBL and will analyze and compile all relevant analytical results associated with this method.

The The Principal Research Scientist I 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. His team will also be supporting analytical outsourcing activities, as needed. The Principal Research Scientist II will ensure phase-appropriate assay validation compliant with internal policies and cGMP requirements. 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 and toxins 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: Set clear goals and milestones for the assay development team.

Team Management: Manage a diverse and high-performing team of and foster a collaborative and innovative work culture.

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

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 departmental operations.

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

Qualifications

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline


• Proven track record of successfully leading teams in the development environment.


• Proven track record in building and managing teams of highly skilled analysts of various levels of experience.


• A deep knowledge of cGMP requirements.


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


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

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 short-term incentive programs.

• 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 Company's 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 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.