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About the Role

AbbVie CMC Development is seeking a Senior Scientist II to join the Downstream Development team as a Scale-Up Laboratory Purification Leader. This role involves leading laboratory-based scale-up activities to develop, optimize, and transfer downstream processes for biologic drug substance manufacturing, advancing next-generation purification platform capabilities. The position requires strong technical expertise, leadership skills, and the ability to collaborate effectively in a team-based, matrixed environment.

Responsibilities

Lead downstream scale-up lab activities and non-GMP material generation to support CMC development, optimization, and transfer of purification processes for biologic candidates.
Maintain operational readiness of the scale-up lab, including equipment availability, workflow planning, consumables, and efficient activity scheduling.
Serve as a subject matter expert and technical lead for downstream scale-up and technology transfer.
Collaborate with and provide technical guidance to project purification development representatives.
Lead downstream technology transfer activities to internal manufacturing sites and external partners.
Prepare transfer packages, provide batch support, and resolve scale-up or execution issues.
Serve as an AKTA subject matter expert (AKTA Ready, AKTA Ready LX, AKTA Avant, AKTA Pure), including method development and execution using UNICORN software.
Drive scientific understanding and execution of downstream unit operations, including resin- and membrane-based chromatography, filtration, viral clearance operations, high-concentration UF/DF, and formulation.
Provide hands-on leadership in large column packing (AxiChrom, QuickScale, BPG), buffer preparation, equipment setup, and unit operation execution.
Develop and implement scale-up lab operational workflows, procedures, and documentation.
Design and execute scale-down and scale-up studies to build process understanding, assess robustness, and improve manufacturing readiness.
Troubleshoot process and equipment issues efficiently and work closely with vendors.
Identify and implement next-generation purification platform strategies and workflow improvements.
Partner effectively across a matrixed organization with upstream, analytical, drug product, manufacturing, and engineering teams.
Mentor junior scientists and, where applicable, manage direct reports.
Author and review technical reports, development summaries, transfer documentation, and regulatory support documents.
Work efficiently and collaboratively to meet program milestones while maintaining high standards for safety, documentation, and data integrity.
Promote a strong safety culture by ensuring scale-up lab activities, equipment use, and material handling practices are executed in accordance with site safety and compliance requirements.

Requirements

Significant experience in downstream/purification process development within a biologics CMC environment.
Demonstrated expertise in process scale-up, scale-down model execution, and technology transfer.
Must be an AKTA systems expert, including deep hands-on experience with UNICORN software.
Hands-on experience operating large-scale TFF processes (hundreds of grams; e.g., Allegro, Cytiva, Repligen, or manually operated skids).
Hands-on experience packing 3–20 L columns with affinity and polishing resins.
Hands-on experience using single-use technologies (e.g., SUMs, pre-packed columns, AKTA flow kits, TFF flow kits).
Hands-on experience operating large-scale filtration processes including depth filtration, virus filtration, and chromatography membrane filtration.
Hands-on experience executing large-volume formulations.
Experience with large column packing, buffer preparation, equipment troubleshooting, and day-to-day laboratory execution.
Proven ability to troubleshoot equipment issues and work effectively with vendors on repairs, reliability improvements, and technical feedback.
Demonstrated leadership skills with ability to lead projects, influence decisions, and mentor others.
Working knowledge of analytical methods such as HPLC, CE, UV-based quantitation, and impurity characterization used to support downstream development.
Must work effectively in a team-based, highly collaborative, matrixed environment.
Strong written and verbal communication skills, including technical writing and scientific data presentation.
Ability to independently design, execute, and interpret experiments to solve complex technical problems.
Strong understanding of biochemistry and bioprocess engineering principles relevant to downstream development and scale-up.
Strong attention to detail and documentation practices.
Experience leading or overseeing a downstream scale-up laboratory or comparable technical development function (Preferred).
Hands-on experience supporting transfer of purification processes to pilot-scale, GMP manufacturing, or external CDMOs (Preferred).
Experience with monoclonal antibodies, bispecifics, or other complex biologic modalities across multiple scales (Preferred).
Experience advancing platform purification strategies or implementing next-generation technologies to improve robustness, cost, and efficiency (Preferred).
Knowledge of statistical tools and data analysis approaches that support process understanding and scale-up decisions (Preferred).

Skills

Downstream Development
Purification Process Development
Biologics CMC
Process Scale-Up
Scale-Down Model Execution
Technology Transfer
AKTA Systems
UNICORN Software
TFF Processes
Column Packing
Single-Use Technologies
Filtration Processes
Chromatography
Viral Clearance
UF/DF
Formulation
Buffer Preparation
Equipment Troubleshooting
HPLC
CE
UV-based Quantitation
Impurity Characterization
Biochemistry
Bioprocess Engineering
Statistical Tools
Data Analysis

Location

South San Francisco

Work Type

Onsite
Laboratory-based

Experience Level

Senior Scientist II
BS and typically 12+ years of experience
MS and typically 10+ years of experience
PhD and typically 4+ years of experience

Education Level

BS in Chemical Engineering, Biochemistry, Chemistry, or other relevant scientific discipline
MS in Chemical Engineering, Biochemistry, Chemistry, or other relevant scientific discipline
PhD in Chemical Engineering, Biochemistry, Chemistry, or other relevant scientific discipline

Salary/Compensations

USD 109500 - USD 208500 - yearly

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Long-term incentive programs

About the Company

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
The Biologics CMC Development team at AbbVie has a long and rich history of biologics development.
Located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing biologic therapies, such as monoclonal antibodies, bi-specifics and novel modalities, to human clinical studies and eventual licensure.

Equal Opportunity

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, visit https://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