Senior Scientist, Process Engineering I

Process Engineering a part of AbbVie R&Ds Development Sciences organization is responsible for designing and developing scalable processes to make drug substances and drug products including small molecules peptides and antibody drug conjugates (ADCs) throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry Manufacturing and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). We contribute to the development of innovative engineering technologies and create valuable intellectual property through the composition of matter chemical processes and technologies resulting in cost-effective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.

Chemical/Bio Engineers within Process Engineering support pipeline projects through all phases of development. Early in development engineers focus on establishing an enabling process that can be scaled up the later stages of development engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work cross-functionally to transfer the optimized process to manufacturing sites develop control strategy and prepare reports to support regulatory filings.

Role Overview

The successful engineering candidate will play a key role in the R&D Process Engineering function. The core deliverable of R&D Process Engineering is to develop robust manufacturing processes and advance innovative technologies using strong engineering fundamentals.  The ideal candidate will have a passion for hands-on laboratory process development.  The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects and take part in a cross-functional team to deliver specific project needs.

Key Responsibilities:

• Develop robust manufacturing processes supporting assets through all phases of development. 
• Participate in development and characterization of new assets.
• Establish communicate and execute research plans.
• Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
• Address challenging problems with reactions separations and/or isolations using expertise in reaction kinetics transport phenomena and mathematical modeling.
• Author and/or review technical documents summarizing process development efforts and contribute to regulatory filings.
• Exhibit a collaborative nature in identifying process challenges on a wide range of projects 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 and regulatory affairs specialists. 
• Author publications and present at scientific conferences. 

Qualifications :

• BS MS or PhD in Chemical/Bio Engineering or a related field and 10 (BS) 8 (MS) or 0 (PhD) years of relevant industrial experience.
• Working knowledge of analytical techniques such as UV/Vis HPLC FTIR Raman mass spectrometry light scattering and microscopy.
• Experience in design of bioprocesses and design of high-throughput experimentation ( Ie.. flow chemistry liquid handling robots ) 
• Experience with mechanistic and/or process modeling.
• Experience employing advanced modeling techniques such as computational fluid dynamics and molecular modeling to drive project impact.
• Experience with laboratory experimentation and process scale-up.
• Experience with design of experiments and statistical tools.
• Experience with GxP compliance.

Key Leadership Competencies:

• Comfortable with multi-disciplinary interactions. Builds strong relationships with peers and cross-functionally with partners outside of team 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 enables innovation to reality.

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 short-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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

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No

Employment Type :

Full-time