What are the responsibilities and job description for the Senior Scientist, Engineering I position at BioSpace?
Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
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 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 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
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Job Description
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 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 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.
- Addresschallenging 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.
- Exhibita collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectivelyby 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.
- 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.
- 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.
- 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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html