Senior Scientist II, Biologics Drug Product Development Full-time

Senior Scientist II

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.

AbbVie's global Drug Product Development team designs and scales formulations and manufacturing processes for complex biologics, including antibodies, antibody drug conjugates, and novel formats, from preclinical stages through clinical proof of concept across both liquid and lyophilized presentations.

We are hiring a Senior Scientist II in South San Francisco to lead end to end formulation and process development. In this role, you will plan and execute DoE driven studies, assess clinical in-use stability, and model degradation pathways. You will establish fit-for-purpose analytical strategies using protein characterization and stability methods such as SEC, CE SDS, icIEF, HIAC, MFI, and DLS. Additionally, you will synthesize complex datasets into clear conclusions and communicate results to technical, leadership, and regulatory audiences while upholding safety, data integrity, and GxP standards.

A core focus of the role is building efficiency at scale by devising and deploying high throughput automated workflows to increase scientific depth and speed across a matrixed, cross site environment. You will mentor and develop laboratory scientists and represent the function on cross functional teams. This is a hands on technical leadership opportunity that converts complex biology into robust, scalable, clinically ready drug products, accelerating and de risking AbbVie's biologics pipeline through scientific rigor, DoE based design, deep analytics, and laboratory automation.

Key responsibilities include:

• Conceive and execute novel scientific research and development that achieves project and functional area goals and produced novel approaches to answer scientific questions and enable the development and characterization of biologic formulations
• Understand and follow project strategic direction and ensures execution within study teams, and seeks guidance when necessary
• Generate new scientific proposals and lead efforts and strategy to drive innovation and implement strategies and approaches to increase efficiency and scientific depth.
• Develop and review detailed study plans to investigate, identify, develop, and optimize liquid and lyophilized drug products through design and execution of formulation, process development, and clinical in-use studies. Utilization and understanding of Design of Experiments (DoE) for planning experiments and modeling results is required.
• Responsible for accumulating and organizing experimental and other relevant data, making appropriate recommendations for analyzing and interpreting results, and effectively communicating finds to various audiences in scientific presentations, technical reports, and regulatory documents
• Maintain solid understanding and hand-on-experience in developing models for and characterizing biologic degradation pathways and introducing robust analytical approaches and techniques for characterization
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug, and GxP compliance where applicable.
• May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals
• Generate high-quality data based on sound scientific principles and document results in electronic lab notebook
• Ability to effectively communicate to various audiences and relay concise, consistent messages
• Represent the function within cross-functional and cross-site technical teams

Qualifications:

• Bachelor's Degree with 12+ years of experience, Master's Degree with 10+ years of experience, or PhD with 4+ years of experience in the biotechnology or pharmaceutical industry.
• Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and deep understanding of characterization approaches.
• Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.)
• Has demonstrated the ability to create automated workflows and successfully implement in a cross-matrixed team with tangible efficiency results.
• Possesses strong computational/programming skills to facilitate automation of workflows and data processing (Hamilton liquid handlers or other automation instruments)
• Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems
• Technical experience with developing fit-for-purpose analytical characterization techniques and drug product presentations
• Prior experience in the development of high-throughput screening workflows for protein formulation development and/or analytical characterization
• Experience in managing and developing laboratory scientists
• Excellent communication and written skills

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. This job is eligible to participate in our short-term incentive programs.

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.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: Reasonable Accommodations

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Pay Range: $106500 – 202500 USD