Jobs · Analyst · California

Scientist I, Biologics Drug Product Development

BioSpace · East Irvine, California, United States · Yesterday
AnalystFull-time
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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description The incumbent in this role will support the formulationand processdevelopment of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization, with a specific focus onselect agentsfor therapeutics and aesthetic use.This position involves designing,executing, andreportinglaboratory experiments to advance the development of stable and effective biologic formulations.The incumbent will collaborate across multidisciplinary teams and contribute to solving technical challenges in both formulation and process optimization, to enable successful clinical and commercial progression of therapeutic biologics. This position requires laboratory work in areas requiring select agents access (i.e., Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Responsibilities Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosageforms.Manufacture drug product formulation batches for evaluating formulation stability and/or for animal studies.Conduct clinical in-use studies to guide dose solutionadministration.Perform analytical testing and characterization of biologic samples, assessing critical quality attributes to support formulation and process decisions.Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant newexperiments.Thoroughly document experimental procedures, results, and interpretations in laboratory notebooks and reports, ensuring compliance with company and regulatory standards.Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, and scientificpresentations.Participate in the evaluation,implementation, and ongoing improvementof newand existing technologies, techniques, and equipment to continuously enhance formulation and process development. Qualifications Bachelors Degree or equivalent education with a minimum 5 years of experience, or Masters Degree or equivalent education with a minimum 2 years of experience.Degree in pharmaceutical sciences, analytical sciences, or equivalent field in the biotechnology industry, preferred.Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.Candidatesmust behighly organized anddetail oriented.Hands-onlaboratoryexperienceinbiologicsformulationdevelopment, drug productmanufacturingprocessesincl.lyophilizationand analyticsisrequired.Hands-on experience working withhighly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment.Experience developing bioassays is strongly preferred.Prior experience with fluorescence anisotropy, qELISA and HPLCis strongly preferred.Strong organizational and documentation skills; ability to maintain accurate experimental records and reports.Effective verbal and written communication skills with the ability to work collaboratively in cross-functional teams. 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 roleat thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified 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 toparticipate in our short-term incentiveprograms. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified 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 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

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