Principal Technical Lead, External Manufacturing - Drug Substance

AbbVie

Principal Technical Lead role overseeing external manufacturing partners for drug substance and intermediate manufacturing. Serves as primary technical interface with contract manufacturers, ensuring processes remain robust, compliant, and meet quality standards while collaborating across Quality, Regulatory, and Supply Chain functions.

Responsibilities

Serve as primary technical representative to external manufacturing partners for assigned products
Maintain detailed understanding of manufacturing processes, critical parameters, and equipment capabilities
Review manufacturing performance, identify trends, risks, and improvement opportunities
Lead technical response to deviations, investigations, root-cause analyses, and CAPAs
Support technology transfers, process scale-ups, validations, and regulatory submissions

Requirements

BS degree with 14+ years experience, or MS with 12+ years, or PhD with 6+ years in relevant discipline
Demonstrated experience with GMP drug-substance manufacturing and process characterization
Experience with validation, deviations, investigations, and technology transfer
Experience managing CMO/CDMO relationships and change control processes
Ability to make technical decisions and influence external partners without direct authority

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Principal Technical Lead, External Manufacturing - Drug Substance in North Chicago, IL vacancy

Principal Technical Lead, External Manufacturing - Drug Substance
...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...
Principal
Full time
Contract work
Local area
AbbVie Inc.
North Chicago, IL
8 days ago
Technical Lead, External Drug Substance Manufacturing
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...
Suggested
AbbVie Inc.
North Chicago, IL
1 day ago
Principal Technical Lead, External Manufacturing - Drug Substance
...achieve project and area goals. Serve as a lead scientist on his/her own project and... ...principle investigator, generating original technical ideas and research or development... ...discipline within the company and possibly externally. Primary author of publications, presentations...
Principal
Full time
Local area
AbbVie
North Chicago, IL
16 hours ago
Senior Scientist II / Principal Scientist I, Biologics Drug Product Development
...seeks a Senior Scientist II or Principal Scientist I to lead biologics drug product formulation and process... ...transfer activities to internal and external manufacturing sites Drive scientific... ...problem-solving skills in complex scientific and technical challenges...
Principal
AbbVie
North Chicago, IL
5 days ago
Principal Scientist II, Analytical Platform Sciences and Characterization, tLNP
...critical support across drug substance (DS) and drug product (DP) manufacturing, drug product... ...formulation, and external partners, and are... ...to serve as Principal Scientist II/Associate... ..., leading a multidisciplinary... ...development. Beyond technical excellence, the role...
Principal
Full time
Local area
AbbVie
North Chicago, IL
5 days ago
Principal PAT Scientist, Analytical R&D Lead
AbbVie seeks a highly motivated PAT scientist to lead a small team and define PAT strategies across drug substance and drug product programs. You will integrate... ...development from early stages through validation and manufacturing transfer. The role requires deep expertise in...
Principal
BioSpace, Inc.
North Chicago, IL
5 days ago
Principal Scientist I, Biologics Drug Product Development
...AbbVie seeks an experienced Principal Scientist I to lead biologics drug product formulation and process development within its Development Sciences... ...technology transfer activities to internal and external manufacturing sites Communicate development plans, risks, and...
Principal
AbbVie
North Chicago, IL
5 days ago
Director - Process Engineering / Senior Principal Research Scientist
...looking for a Senior Principal Research Scientist... ...'s possible in drug product... ...the future of drug manufacturing. Whether you join... ...accountability for setting technical strategy and may include... ...to raise the bar, lead with influence,... ...with internal and external collaborators....
Principal
Full time
Work experience placement
Local area
AbbVie Inc.
North Chicago, IL
11 days ago
Director - Process Engineering / Senior Principal Research Scientist
...AbbVie seeks a Senior Principal Research Scientist or Director of Process Engineering to lead drug product manufacturing development for small molecule candidates. The role involves... ...commercial production and may include technical leadership responsibilities at the director...
Principal
AbbVie
North Chicago, IL
5 days ago
Principal Scientist I, Biologics Drug Product Development
...Description Biologics Drug Product Development... ...Scientist II / Principal Scientist I,... ...plants and third-party manufacturers. Key Responsibilities... ...to internal and external manufacturing sites. Lead the design and... ...authority, drives technical excellence, and inspires...
Principal
Full time
Temporary work
Local area
AbbVie Inc.
North Chicago, IL
more than 2 months ago
Principal Scientist I, Biologics Drug Product Development
...Description Biologics Drug Product Development... ...Scientist II / Principal Scientist I,... ...plants and third-party manufacturers. Key... ...activities to internal and external manufacturing sites. Lead the design and execution... ...authority, drives technical excellence, and...
Principal
Temporary work
Local area
AbbVie
North Chicago, IL
11 days ago
Principal Scientist I, Biologics Analytical R&D (External Programs)
...monoclonal antibodies, antibody drug conjugates (ADC), and other... ...the advancement of industry-leading analytical capabilities and make... ...The Analytical Development – External Programs group within... ...documents, laboratory data, technical memos and reports. Proactively...
Principal
Full time
Work experience placement
Local area
AbbVie Inc.
North Chicago, IL
more than 2 months ago
Principal Research Scientist II
...talented, and creative Principal Research Scientist... ...offering advanced technical expertise in the... ...of parenteral manufacturing processes. This... ...development, quality and external partners to ensure... ...of the drug product. In your... ...priorities and short lead times for multiple...
Principal
Full time
Local area
AbbVie Inc.
North Chicago, IL
more than 2 months ago
Principal Scientist - Obesity Discovery & External Innovation
...expanding its Obesity Therapeutics program and seeks a Principal Scientist to lead external innovation efforts and diligence for obesity assets. The... ...studies, analyze dataset integrity, and prepare technical reports while working with CROs and academic labs, reporting...
Principal
AbbVie
North Chicago, IL
1 day ago
Principal Research Scientist I, Peptide Chemistry
...AbbVie seeks a Principal Research Scientist I to lead peptide chemistry projects in manufacturing process development and commercialization... ...regulatory documentation and technical innovations.... ...of GxP compliance and handling of controlled drug compounds...
Principal
AbbVie
North Chicago, IL
2 days ago
Principal Research Scientist II, Molecular Profiling and Drug Delivery (MPDD)
...Molecular Profiling and Drug Delivery (MPDD)... ...screening, lead generation, and lead... ...strategies across drug substance and drug product.... ...and leverage external innovation.... ...computational chemistry for a Principal Scientist II... ...provide expert advice, technical guidance, and...
Principal
Full time
Work experience placement
Local area
AbbVie Inc.
North Chicago, IL
a month ago
Principal Systems Engineer I - Power Platform
...SummaryThis role serves as a principal-level technology leader responsible... .... The role provides technical leadership for the design, implementation... ..., drive platform maturity, lead complex technical initiatives... ....Interacts with internal and external peers and management to share...
Principal
Hourly pay
Work at office
Remote work
Walgreens Boots Alliance
Deerfield, IL
1 day ago
Principal Engineer
...assignments related to a specific technical field or discipline. A Principal Engineer has full... ...development, and manufacturing to establish scope, priorities... .... A Designs and leads complex experiments, often... ...both senior management and external personnel on significant...
Principal
BioSpace, Inc.
North Chicago, IL
3 days ago
Senior IT Technical Lead
$120k - $140k
...look for top talent to join our team as we lead the charge in revolutionizing industrial... ...You’ll bring to this Role:The Senior IT Technical Lead is the hands-on technical owner for... ...Microsoft Fabric, Power BI, along with manufacturing ERPs; and leads the projects, vendors,...
Full time
Temporary work
Flexible hours
Justrite Manufacturing Company
Deerfield, IL
9 hours ago
Principal Research Scientist II, Process Chemistry
...highly motivated Principal Research Scientist... ...across drug substance modalities, including... ...difficult scientific and technical challenges. The... ...and/or lead project teams associated... ...processes for cGMP manufacturing. Qualifications... ...internal and external collaborators to...
Principal
Full time
Work experience placement
Local area
AbbVie Inc.
North Chicago, IL
more than 2 months ago
Principal Peptide Process Engineer, Research Scientist II
...process steps from the lab to a manufacturing environment. Once... ...continuous improvement activities, technical transfer to manufacturing sites... ...successful performance. Purpose Lead research and/or project... ...trends from multiple internal and external sources, assess relevance,...
Principal
Temporary work
Work experience placement
AbbVie
North Chicago, IL
3 days ago
Technical Lead (Pharmacy Applications)
...We are partnering with a leading enterprise organization seeking a Technical Lead (Pharmacy Applications) to provide hands-on technical leadership across a... ...systems, middleware technologies, shipping vendors, and external partners. Collaborate with business stakeholders,...
Full time
Contract work
Local area
3 days per week
Beacon Hill
Waukegan, IL
2 days ago
Principal Peptide Process Engineer, Research Scientist II
...process steps from the lab to a manufacturing environment. Once... ...continuous improvement activities, technical transfer to manufacturing sites... ...from multiple internal and external sources and assess relevance... ...Leadership Activities: Leads resolution of compliance quality...
Principal
Full time
Temporary work
Work experience placement
Local area
AbbVie Inc.
North Chicago, IL
more than 2 months ago
Principal Engineer
...submissions, and commercial manufacturing. This group has a... ...products, (drug, device, packaging, and... ...optimize asset value. Leads cross functional teams... ...implementation by utilizing technical training and / or experience... ..., using extensive external resources. Demonstrated...
Principal
Full time
Local area
AbbVie Inc.
North Chicago, IL
a month ago
Principal Scientist II, Analytical Platform Sciences and Characterization, tLNP
...AbbVie seeks a Principal Scientist II to lead analytical platform sciences for targeted lipid nanoparticle... ...innovation across mRNA-LNP drug development. Responsibilities Establish... ...stakeholders, academic partners, and external technology providers Requirements...
Principal
AbbVie
North Chicago, IL
4 days ago
Senior Principal Engineer, Plastics Molding — Pharmaceutical Manufacturing & Medical Devices
...Senior Principal Engineer providing enterprise-level technical leadership for plastic injection and blow... ...and medical device manufacturing. The role manages complex... ...with internal teams and external suppliers to develop... ...Responsibilities Lead medium to large-scale molding...
Principal
AbbVie
North Chicago, IL
2 days ago
Principal Engineer
...production coordination. Must work with manufacturing personnel, quality, labs, supply chain,... ...factors, materials, or processes. Provide technical expertise or support related to... ...systems, desired. • Hands-on experience in drug product aseptic manufacturing operations...
Principal
Samprasoft
Round Lake, IL
3 days ago
Principal Research Scientist I, Process Chemistry (Biocatalysis)
...AbbVie seeks a Principal Research Scientist I with deep... ...chemistry across multiple drug modalities.... ...enzyme optimization Lead or participate in process... ...drug conjugates Author technical reports, patents, publications... ...at internal and external forums Requirements...
Principal
AbbVie
North Chicago, IL
2 days ago
Senior Director Process Engineering Peptides API
...direction and senior technical governance for process... ...technical assurance, manufacturing technology interfaces... ...for biologics drug substance and cell and gene therapy... ...validation / CQV and external engineering partners... ...Leadership and Delivery: ~ Lead or support technical...
Full time
Temporary work
Local area
AbbVie Inc.
North Chicago, IL
26 days ago
Senior Director Process Engineering
...direction and senior technical governance for process... ...technical assurance, manufacturing technology interfaces... ...for biologics drug substance and cell and gene therapy... ...validation / CQV and external engineering partners... ...and Delivery \n\n \n Lead or support technical...
Local area
AbbVie
North Chicago, IL
20 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Principal Technical Lead, External Manufacturing - Drug Substance. Be the first to apply!