Senior Scientist I, Biologics Purification Development (Mechanistic Modeling & AIML)

The Biologics CMC Development team at AbbVie has a distinguished history of advancing complex biologic therapies through all phases of development from discovery to licensure. Our state-of-the-art facility in South San Francisco provides comprehensive CMC capabilities and a highly collaborative environment focused on innovative drug substance development. You will join a team that has enabled 20 IND submissions and two successful BLAs.

We are seeking a highly motivated Senior Scientist I to join the Purification Development team. This individual will apply mechanistic modeling  and/or advanced AI / machine learning (ML) strategies to the development optimization and scale-up of robust phase-appropriate purification processes for biotherapeutic candidates. The ideal candidate will leverage historical and incoming process data to drive process understanding forecast outcomes and accelerate project timelines.

Key Responsibilities:

• Design implement and validate mechanistic models and/or AI/ML (e.g. for process performance prediction process understanding and workflow optimization) using historical and real-time data from lab scale purification development and pilot/GMP manufacturing.
• Actively seek out opportunities to optimize current platform or enhance our understanding of purification unit operations using advanced models and wet lab experiments.
• Contribute to or drive mechanistic modeling efforts for chromatography and/or membrane separations supporting process control and troubleshooting.
• Execute wet lab validation experiments with detailed documentation practices.
• Collaborate closely with cross-functional teams to meet project deliverables and timelines.
• Analyze complex datasets utilize advanced data visualization tools and communicate data-driven recommendations to technical teams.
• Proactively monitor relevant scientific literature and integrate innovative bioprocess advances.
• Write technical publications reports presentations and regulatory filings; publish research in peer-reviewed journals and present work at scientific conferences.
• Mentor junior staff and uphold best practices in documentation safety and GxP compliance where applicable.

Qualifications :

• BS MS or PhD in Computer Science Statistics Applied Mathematics Bioinformatics Machine Learning Computational Biology Data Science Chemical Engineering Bioengineering or a related field with typically 10 years (BS) 8 years (MS) or 0 years (PhD) of industry or research experience as either: an expert in mechanistic modeling for protein separations with some demonstrated proficiency in AI/ML approaches.
• Able to manage and organize large data sets to help interpret results using data visualization tools.
• Strong understanding of statistical analysis process modeling and data visualization.
• Able to independently design execute use and reference literature publications and interpret laboratory experiments to answer scientific questions.
• Must be forward-thinking and be able to lead and contribute to technical discussions and innovation.
• Able to independently learn understand and execute novel advanced scientific techniques related to bioprocess development.
• Has strong communication skills including verbal written and scientific data presentation.
• Understands biochemistry and bioprocess engineering concepts.
• Strong attention to detail; active and quick learner; able to change course quickly as needed; raises the bar and is never satisfied with the status quo; open to suggestions and embraces the ideas of others; collaborative actively builds relationships with others.
• Experienced in authoring and reviewing peer-reviewed publications technical reports regulatory documents and/or presentations at conferences.

Preferred Qualifications:

• Demonstrated experience developing deploying and interpreting mechanistic models of purification processes (GoSilico CADET or similar framework) and/or machine learning models (Python scikit-learn TensorFlow or similar frameworks).
• Proven track record in applying mechanistic modeling or AI/ML for process optimization in bioprocessing.
• Strong programming competency to implement debug and maintain models and tools in Python or equivalent and proficiency with cloud computing capabilities.
• Hands-on experience with chromatographic instruments (FPLC such as AKTA HPLC/UPLC).
• Knowledge of Design of Experiments (DOE) process control and process validation strategies.
• Familiarity with CMC process development from early to late stage and technology transfer into GMP manufacturing environments.

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. 

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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time