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Senior Scientist II, Technical Operations

AbbVie

North Chicago, IL, United StatesFull TimeSeniorH-1B sponsor company
Sign in to applyVerified 1h ago
Location
North Chicago, IL, United States
Employment
Full Time
Work model
On-Site
Level
Senior
H-1B history
94 approvals (FY2023)
Posted
1h ago

About this role

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

The Process Engineering and API Clinical Supplies (PEACS) organization within AbbVie’s Synthetic Molecule CMC (Chemistry, Manufacturing, and Control) Division in Development Sciences invents synthetic processes to prepare active pharmaceutical ingredients (APIs) to enable the development of AbbVie’s pipeline and supply materials for clinical programs. AbbVie is seeking a highly motivated individual with a proven track record of accomplishment to join the API Pilot Plant Technical Operations (Tech Ops) group. This position will serve as a liaison between the synthetic molecule CMC scientific functions and the API Pilot Plant organization to ensure safe and robust scale up of API manufacturing processes. The successful candidate will assist in the optimization and scale-up of synthetic processes and facilitate the implementation of new technologies in the API Pilot Plant. The Scientist will also provide technical oversight during production campaigns and will support technical transfer to the ultimate commercial manufacturing site.

Responsibilities

Technical and project management of processes entering the API Pilot Plant, including scheduling, equipment selection, materials tracking, authoring direction sets, obtaining safety analyses, and executing pre-runs. Partner with API project teams to optimize processes for scale-up. Identify appropriate equipment, sizing, and configurations. Technical oversight of processes running in the API Pilot Plant, and responsibility for process-troubleshooting in collaboration with the API project teams. Serves as the primary point of contact between API Pilot Plant, API project teams, Quality Assurance, and Environmental Health and Safety. Build data-driven and knowledge-driven models to facilitate successful scale-up and tech transfer. Identify, evaluate, and implement new technologies for the pilot plant and/or identify opportunities to modify or leverage existing assets to enhance operational efficiency, which strategically align with the long-term goals of the API Pilot Plant. Examples include automation, flow chemistry, novel separations, Process Analytical Technology (PAT), feedback control, and drying technologies. Support the implementation of PAT. Assist with equipment specification, setup, data collection, and analysis. Support the introduction of new modalities into the plant. Interface with API project teams to ensure that processes are safe, scalable, and operable. Assist with technology transfer of late-stage processes to commercial sites, including process fit, identification of equipment needs, and facility modifications. Responsible for review and documentation of data for cGMP execution of chemical processes. Authors campaign summary reports. Exhibit a collaborative nature in identifying process challenges and communicate findings and recommendations effectively by multi-disciplinary interactions with organic chemists, analytical chemists, process development engineers, pilot plant engineers, drug product development scientists, program managers, quality assurance specialists, and regulatory affairs specialists. Author publications and present at scientific conferences.

Qualifications

Level and compensation will be commensurate with experience. BS, MS, or PhD in Chemical Engineering or Chemistry with relevant industry experience: 10+ years for BS 8+ years for MS 4+ years

Senior Scientist II, Technical Operations at AbbVie — North Chicago, IL, United States | Yoinka