Principal Research Scientist I, Process Engineering
1 month ago
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
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 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 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 ADC development experience and 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, 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:
Develop robust manufacturing processes, supporting antibody drug conjugate assets through all phases of development.Participate in and/or lead project teams towards development and characterization of new antibody drug conjugate assets. Establish, communicate, and execute research plans.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.Addresschallenging 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.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.Qualifications
Qualifications:BS, MS, or PhD in Chemical/Bio Engineering or a related field and 14+ (BS), 12+ (MS), or 6+ (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 realities
Additional Information
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. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit
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