Principal Technical Lead, External Manufacturing - Drug Substance

AbbVie Inc.; North Chicago (IL); On-site; USD 160,000 - 230,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie Inc. seeks a Technical Lead to oversee external manufacturing partners for drug substance and intermediates. You will ensure robust, compliant processes and deliver consistently high-quality product through cross-functional collaboration with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement.

Lead technology transfers, process validation, CPV, and post-approval changes while guiding deviations, investigations, and continuous improvements across CMOs/CDMOs.

Qualifications

• BS or equivalent education with extensive experience (14+ years).
• MS or equivalent education with typically 12+ years.
• PhD with typically 6+ years in the relevant discipline.

Responsibilities

• Serve as the primary technical representative to external manufacturing partners for assigned products and processes.
• Maintain detailed understanding of manufacturing processes, critical parameters, quality attributes, process controls, equipment capabilities, and process performance.
• Review manufacturing performance and identify trends, risks, variability, and opportunities for improvement.
• Provide technical leadership for deviations, investigations, CAPAs, and troubleshooting.
• Assess the technical impact of manufacturing changes across equipment, materials, parameters, scale, and facilities.
• Lead or support technology transfers, process scale-up, PPQ, CPV, and site introductions.
• Provide input to change controls, regulatory submissions, validation strategies, and product lifecycle management.
• Partner with Quality to ensure GMP standards in external manufacturing operations.
• Work with Supply Chain to mitigate risks affecting product supply.
• Lead governance discussions with CMOs/CDMOs and escalate issues as needed.
• Develop and monitor process performance metrics and communicate risks and improvements.

Skills

GMP knowledge

External partner influence

Technical leadership

Education

BS or equivalent education

MS or equivalent education

PhD with experience

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 technicalinterface between the company and its contract manufacturing organizations (CMOs/CDMOs), ensuring manufacturing processesremainrobust,reproducible, compliant, and capable of consistently delivering product that meetestablishedquality and supply requirements.

The incumbent will provide end-to-endtechnical 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 manufacturingpartners for assigned products and processes.
• Maintain detailed understanding of manufacturing processes, critical process parameters, critical quality attributes, process controls, equipmentcapabilitiesand process performance.
• Review manufacturing performance andidentifyprocess 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 technicaland GMP standards.
• Work with Supply Chain and External Manufacturing toidentifyand mitigate technical risks that could affect product supply.
• Lead technical governance discussions with CMOs/CDMOsand ensure technical issues are appropriately escalated and resolved.
• Develop andmonitorprocess performance metrics and communicate manufacturing performance, technical risks, and improvement opportunities to internal stakeholders.
• Drive processrobustness, 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 projectteamthroughlab based, or other workenvironments, 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, technologytransfer, 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 directorganizational authority.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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