Associate Scientist II, Biologics Drug Product Development
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
Position Description: The incumbent in this role will support the formulation & process development of protein biologics for clinical stage molecules with a specific focus on highly potent molecules for therapeutics and aesthetic use. This position requires laboratory work in areas requiring select agents and highly-potent-compound 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, andobjectives. Responsibilities - Design and 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/orto supportin vivostudies.
- Conduct clinical in-use studies to guide dose administration.
- Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant newexperimentsaccordingly.
- Generate high-quality data based on sound scientificunderstandingand prepare formulation data summaries, technical reports, and scientific presentations.
- Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug productdevelopment.
- Accurately document and report experiments in full compliance with GSP standards
Qualifications
- BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of industry experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry. This opportunity will not consider applicants with a PhD.
- CMC development experience in protein formulation, drug delivery, or analytical functions ispreferred.
- Candidates mustexhibitthe technical ability to execute and troubleshoot experiments through rational and critical thinking.Mustbe highly organized anddetail oriented.
- Hands-on experience with analytical techniques used for protein characterization and stabilitystudies(e.gHPLC, CE-SDS, spectroscopy,HIAC, MFI, DLS, ELISA, Karl Fisher)arepreferred.
- Prior experience with drug productmanufacturingprocesses and lyophilizationaredesirable.
- Excellent communication skillsarerequired.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: - Candidates based in Southern California are encouraged to apply. Relocation assistance is not guaranteed for those not living in a commutable distance to Irvine, CA or willing and able to self-relocate.
- 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat 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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