Senior Scientist II, Technical Operations

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 for PhD 

• Familiarity with modeling and simulation tools such as MATLAB, Python, C++, COMSOL, Scale-Up Suite, or M-Star. 

• Experience in process development and strong working knowledge of unit operations commonly used in small molecule synthesis (e.g., reactions, separations, distillation, crystallization, etc). 

• Demonstrated experience scaling chemical processes from the laboratory to the pilot plant. 

• Solid understanding of fundamental chemical scale-up and process safety principles. 

Preferred 

• 3+ years of experience in pharmaceutical development and/or scaling processes from lab to the pilot scale. 

• Experience partnering with EHS for the scale-up of safe processes.  

• Advanced understanding of chemical processing engineering principles. 

Key Leadership Competencies 

• Builds strong relationships with peers and cross functionally with partners to enable higher performance. 

• Learns fast, grasps the "essence" and can change course quickly where indicated. 

• Raises the bar and is never satisfied with the status quo. 

• Creates a learning environment, open to suggestions and experimentation for improvement. 

• Embraces the ideas of others, nurtures innovation and manages innovation to reality. 

• Strong interpersonal and communication skills with demonstrated ability to work within a team environment. 

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 thisposting 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 anduntil 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

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