Principal Technical Lead, External Manufacturing - Drug Substance

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

AbbVie is seeking a Technical Lead to manage external manufacturing partnerships for drug substances and intermediates, ensuring robust, compliant processes that meet quality and supply requirements.

You will provide end-to-end technical stewardship, collaborating with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement while driving process improvement and technology transfers.

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Demonstrated experience with GMP drug-substance manufacturing, process characterization, and validation, deviations/investigations, technology transfer, change control, process monitoring, and CMO/CDMO management is highly preferred.
• Comfortability in making technical decisions and influencing external partners and senior internal stakeholders without direct organizational authority.

Responsibilities

• Serve as the primary technical representative to external manufacturing partners for assigned products and processes.
• Maintain detailed understanding of manufacturing processes, critical process parameters, critical quality attributes, process controls, equipment capabilities and process performance.
• Review manufacturing performance and identify process trends, risks, variability, and opportunities for improvement.
• Provide technical leadership for manufacturing deviations, investigations, root-cause analysis, CAPAs, and process related troubleshooting.
• Asses the technical impact of manufacturing changes, including equipment, raw materials, process parameters, scale, facilities, and manufacturing strategy.
• Lead or support technology transfers, process scale-up, process validation (PPQ), continued process verification (CPV), and introduction of processes to new manufacturing sites.
• Provide technical input to change controls, regulatory submissions, validation strategies, comparability assessments, and product lifecycle management.
• Partner with Quality to ensure external manufacturing operations maintain appropriate technical and GMP standards.
• Work with Supply Chain and External Manufacturing to identify and mitigate technical risks that could affect product supply.
• Lead technical governance discussions with CMOs/CDMOs and ensure technical issues are appropriately escalated and resolved.
• Develop and monitor process performance metrics and communicate manufacturing performance, technical risks, and improvement opportunities to internal stakeholders.
• Drive process robustness, manufacturing efficiency, yield improvement, cycle-time reduction, and other continuous improvement initiatives.
• Support regulatory inspections and health-authority inquiries related to externally manufactured drug substances.
• Make significant contributions to project team through lab based, or other work environments, activities, as needed.

Skills

GMP

Process validation

Technology transfer

Change control

Statistical analysis

Education

Bachelor's degree

Master's degree

PhD

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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

This role will provide technical oversight for our external manufacturing partners which encompasses drug substance and intermediate manufacturing. The Technical Lead will serve as the primary technical interface between the company and its contract manufacturing organizations (CMOs/CDMOs), ensuring manufacturing processes remain robust, reproducible, compliant, and capable of consistently delivering product that meet established quality and supply requirements.

The incumbent will provide end-to-end technical stewardship of externally manufactured processes and work cross functionally with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement.

Responsibilities

• Serve as the primary technical representative to external manufacturing partners for assigned products and processes.
• Maintain detailed understanding of manufacturing processes, critical process parameters, critical quality attributes, process controls, equipment capabilities and process performance.
• Review manufacturing performance and identify process trends, risks, variability, and opportunities for improvement.
• Provide technical leadership for manufacturing deviations, investigations, root-cause analysis, CAPAs, and process related troubleshooting.
• Asses the technical impact of manufacturing changes, including equipment, raw materials, process parameters, scale, facilities, and manufacturing strategy.
• Lead or support technology transfers, process scale-up, process validation (PPQ), continued process verification (CPV), and introduction of processes to new manufacturing sites.
• Provide technical input to change controls, regulatory submissions, validation strategies, comparability assessments, and product lifecycle management.
• Partner with Quality to ensure external manufacturing operations maintain appropriate technical and GMP standards.
• Work with Supply Chain and External Manufacturing to identify and mitigate technical risks that could affect product supply.
• Lead technical governance discussions with CMOs/CDMOs and ensure technical issues are appropriately escalated and resolved.
• Develop and monitor process performance metrics and communicate manufacturing performance, technical risks, and improvement opportunities to internal stakeholders.
• Drive process robustness, manufacturing efficiency, yield improvement, cycle-time reduction, and other continuous improvement initiatives.
• Support regulatory inspections and health-authority inquiries related to externally manufactured drug substances.
• Make significant contributions to project team through lab based, or other work environments, activities, as needed.

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
• Demonstrated experience with GMP drug-substance manufacturing, process characterization, and validation, deviations/investigations, technology transfer, change control, process monitoring, and CMO/CDMO management is highly preferred.
• Comfortability in making technical decisions and influencing external partners and senior internal stakeholders without direct organizational authority.

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 long-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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.

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