Senior Scientist II, QTAS Biologics Project Representative

ZipRecruiter; North Chicago (IL); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced scientist to lead innovative research and development in biologics. This role involves collaboration with project teams to drive PK/PD strategies and regulatory document preparation. Ideal candidates will have a strong background in biological sciences and demonstrated leadership in a fast-paced team environment. Competitive benefits are offered.

Benefits

Medical/dental/vision insurance

401(k) plan

Paid time off

Qualifications

• Experience independently representing QTAS on biologics project teams is required.
• Expertise with PK analysis of biologics and relevant data analysis software.
• Familiarity with modeling software such as MATLAB, R, or Python is desired.
• Understanding of biologics PK/PD modeling and analytical assays is desired.
• Demonstrated scientific leadership and ability to influence.

Responsibilities

• Serve as a QTAS representative on project teams managing novel biologics.
• Develop and drive the QTAS and PK/PD strategies for projects.
• Communicate QTAS and PK/PD strategy to stakeholders effectively.
• Conduct quantitative analyses to support project strategies.
• Prepare regulatory documents and respond to inquiries.

Skills

Scientific leadership

Data analysis

Collaboration

Communication

Networking

Education

Bachelor’s Degree + 12 years experience

Master’s Degree + 10 years experience

PhD + 4 years experience

Tools

Phoenix/WinNonlin

MATLAB/SimBiology

R

Python

Job description

Job DescriptionJob DescriptionCompany Description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

Purpose

Conceive and execute novel scientific research or development that achieves projects and area goals. Generate new scientific proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques. Act as a lead scientist in his/her area of expertise and critically evaluate relevant scientific and regulatory advances and integrate this knowledge into research or development programs.

The Quantitative, Translational and ADME Sciences (QTAS) group is searching for an experienced project representative to provide biologics project support across all therapeutic areas for molecules in discovery and clinical development. The position requires close collaboration with Discovery and Development project teams, clinical pharmacology, and other stakeholders, developing and executing QTAS and PK/PD strategies necessary to facilitate the advancement of our pipeline.

Responsibilities

• Serve as a QTAS representative on project teams supporting the development of novel biologics; collaborate with project team members (e.g., clinical pharmacology, protein analytics, discovery, toxicology) and groups within QTAS to generate relevant data guiding target validation, biomarker selection, and candidate selection
• Develop and drive the QTAS and PK/PD strategy for large molecule discovery, preclinical, and clinical development projects to support decisions and milestone transitions
• Effectively communicate QTAS and PK/PD strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions
• Demonstrate thorough understanding of the PK/PD and bioanalytical aspects necessary for the selection and characterization of antibodies, including considerations for bispecific antibodies, antibody-drug conjugates, and novel modalities
• Coordinate and request PK, PK/PD, and bioanalytical studies in a timely manner and communicate protocols, timelines, needs and results back to team, ensuring optimized cycle times
• Conduct value-added PK/PD-related quantitative analyses to support project team or project strategy decision-making
• Serve as a liaison with bioanalytical groups to ensure timely reagent , method development and sample analysis
• Prepare QTAS sections of regulatory documents (IB, IND, BLA); provide responses to regulatory questions and ensure of appropriate reports

*Level and compensation will be commensurate with experience

Qualifications

• Bachelor’s Degree or equivalent education with 12+years of experience, orMaster’s Degree or equivalent education with 10+ years of experience, orPhD with 4+ years of experience within the pharmaceutical or biotechnology industries.
• Experience independently representing QTAS on biologics project teams is required (expertise with novel modalities is )
• Expertise with PK analysis of biologics and relevant data analysis software such as Phoenix/WinNonlin
• Familiarity with modeling software such as MATLAB/SimBiology, R, Python, or Berkeley Madonna is desired
• Understanding of biologics PK/PD modeling and analytical assays for measuring biologic molecules and biomarkers (including ligand binding and mass spectrometry assays) in preclinical study samples is desired
• Demonstrated scientific leadership including generating original scientific investigative strategies and guiding those efforts to an effective and productive outcome
• Recognized expert in his/her discipline
• Demonstrated publication or patent record; lead/senior author contributions a plus
• Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment
• Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver
• High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills
• Passion for data analysis, solving technical problems and applying new technologies to further scientific goals

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• 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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.

• This job is eligible to participate in 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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s 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