Future Opportunities, Join our talent community for Sr Scientist II/Principal Scientist in Bioprocess Engineering

About the role

Process Engineering, a part of AbbVie R&D's Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including small molecules 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 successfully. In 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 candidate will play a key role in the BioProcess Engineering (BPE) Center, a part of the Process Engineering function. The core deliverable of BPE is to develop robust manufacturing processes and advance innovative technologies using strong engineering fundamentals. The ideal candidate will have prior biologics and/or ADC development experience and a passion for hands-on laboratory process development.

Roles and responsibilities will be commensurate with experience and may range from an individual contributor collaborating on project teams to a cross-functional team leader who establishes strategy for process design. 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, take part in a cross-functional team to deliver specific project needs, and take on a leadership role in developing and implementing solutions.

Key Responsibilities

• Participate in and/or lead process development for bioprocesses including:
• Develop robust manufacturing processes, supporting assets through all phases of development.
• Establish, communicate, and execute research plans to develop and characterize new assets.
• Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
• Set project strategies, define project responsibilities and timelines, and provide leadership in a matrixed team setting.
• Address challenging problems with biochemical 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 12+ (BS), 10+ (MS), or 4+ (PhD) years of relevant industrial experience.
• Ph.D. candidates with pertinent research exposure are also encouraged to apply.
• Job level will be commensurate with academic and/or industrial work experience.
• Candidates are expected to have a strong background in chemical engineering and the proven ability to demonstrate their skills in this field.
• The candidate is expected to demonstrate the ability to solve difficult technical problems and champion new technologies to achieve project goals.
• The candidate is required to be a strong team player and demonstrate scientific leadership, possessing effective oral and written communication skills for facilitating collaborations and leading cross-functional process development teams.

Preferred

• Biologics process development experience, particularly in bioconjugation, antibody drug conjugate process development, and/or purification of proteins, such as preparatory chromatography and tangential flow filtration.
• Working knowledge of analytical techniques such as UV/Vis, HPLC, FTIR, Raman, and microscopy.
• Experience with laboratory experimentation and process scale-up.
• Experience with mechanistic and/or process modeling or computational fluid dynamics.
• Experience with design of experiments and statistical tools.
• Familiarity with operation of chemical/biochemical process equipment and systems.
• Experience with control strategy development, risk assessments, and tech transfer.
• Experience with GxP compliance and potent compound handling.
• Experience with leading cross-functional pharmaceutical development teams.

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

All your information will be kept confidential according to EEO guidelines.