Scientist - Biologics Technical Operations

Job description

Company Description About 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com .

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Job Description

The Biologics Technical Operations Scientist provides advanced technical and engineering leadership, along with program management support, to biologics manufacturing operations on site. This role is accountable for sustaining existing biologics products, resolving complex technical challenges, ensuring compliance with regulatory and quality expectations, and driving continuous improvement through innovative process enhancements, improved controls, and robust execution across the manufacturing lifecycle.

Major Responsibilities

Provide hands-on technical leadership to Production Team Leaders to optimize process performance, improve equipment reliability, and resolve complex manufacturing issues. Lead process development activities for existing products including tech transfer and successful scale-up to plant equipment. Develop and implement process controls to optimize commercial manufacturing processes and strengthen process robustness. Design and refine process control for the continuous improvement of existing commercial processes.

Manage process improvement projects from initiation through execution, ensuring delivery against scope, timeline, budget, quality expectations, and regulatory requirements. Support and uphold all EHS standards, procedures, and policies, promoting a strong culture of safety and compliance. Lead root cause analysis investigations for process non-conformances and develop effective, sustainable CAPAs in alignment with regulatory expectations.

Design and execute pilot-scale manufacturing DOE studies to generate development packages and support technical decision-making. Provide technical support for commissioning and validation activities throughout project execution. Ensure compliance with all applicable Corporate, Divisional, quality, and regulatory policies, procedures, and requirements.

Qualifications

Relevant third-level degree or higher in Chemical Engineering, Process Engineering, or a related technical discipline. Bachelor’s degree or equivalent education with typically 3 years of experience in biologics manufacturing, or Master’s degree or equivalent education with typically 2 years of experience. Demonstrated project management capability, including the ability to lead cross-functional workstreams and deliver projects on schedule, within budget, and to predefined quality standards.

Strong analytical, problem-solving, and decision-making skills with the ability to influence technical and regulatory outcomes. Proven ability to work effectively across operations, quality, engineering, validation, and regulatory functions. Additional Information Key Stakeholders Production Team Leaders Manufacturing Operations Process Development Quality Assurance Validation Engineering EHS&E Regulatory Affairs Project/Program Management 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