Senior Scientist II, Biologics Drug Product Development
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
Summary: AbbVies global Drug Product Development team designs and scales formulations and manufacturing processes for complex biologics, including antibodies, antibody drug conjugates, and novel formats, from preclinical stages through clinical proof of concept across both liquid and lyophilized presentations. We are hiring a Senior Scientist II in South San Francisco to lead end to end formulation and process development. In this role, you will plan and execute DoE driven studies, assess clinical in-usestability, and model degradation pathways. You willestablishfit-for-purpose analytical strategies using protein characterization and stability methods such as SEC, CE SDS,icIEF, HIAC, MFI, and DLS. Additionally, you will synthesize complex datasets into clear conclusions and communicate results to technical, leadership, and regulatory audiences while upholding safety, data integrity, andGxPstandards. A core focus of the role is building efficiency at scale by devising and deploying high throughput automated workflows to increase scientific depth and speed across a matrixed, cross site environment. You will mentor and develop laboratory scientists and represent the functiononcross functional teams. This is ahands ontechnical leadership opportunity that converts complex biology into robust, scalable, clinically ready drug products, accelerating and de risking AbbVies biologics pipeline through scientific rigor, DoE based design, deep analytics, and laboratory automation. Responsibilities: - Conceive and execute novel scientific research and development that achieves project and functional area goalsand produced novel approaches to answer scientific questions and enable the development and characterization of biologic formulations
- Understand and follow project strategic direction and ensures execution withinstudy teams, and seeks guidance when necessary
- Generate new scientific proposals and lead efforts andstrategyto drive innovationand implement strategies and approaches to increase efficiency and scientific depth.
- Developand reviewdetailed study plans to investigate,identify,develop,andoptimizeliquid and lyophilized drug products through design andexecution of formulation, process development, and clinical in-use studies.Utilizationand understanding ofDesign ofExperiments (DoE)for planning experiments andmodelingresultsisrequired.
- Responsiblefor accumulating and organizing experimental and other relevant data,makingappropriate recommendationsforanalyzing and interpreting results,and effectively communicating finds to various audiencesin scientific presentations, technical reports, and regulatory documents
- Maintain solid understanding and hand-on-experience in developing modelsforand characterizing biologic degradation pathwaysand introducing robust analytical approaches and techniques for characterization
- Understand and adhere to corporate standardsregardingcode of conduct, safety,appropriate handlingof materials, controlled drug, andGxPcompliance where applicable.
- May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals
- Generate high-quality data based on sound scientific principlesand document results in electronic lab notebook
- Ability to effectively communicate to various audiences and relay concise, consistent messages
- Represent the function within cross-functional and cross-site technical teams
Qualifications
- PhDwith4+years of experiencein the biotechnology or pharmaceutical industry.
- Strong technical background in formulation principles, drug product degradation pathways,drug product lyophilizationand processing,anddeep understanding ofcharacterization approaches.
- Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS,icIEF, HIAC, MFI, DLS, etc.)
- Hasdemonstratedthe ability to create automated workflows and successfully implement in a cross-matrixed team with tangible efficiency results.
- Hasexperienceleading drug product development as the functional lead within cross-functional teams
- Possesses strong computational/programming skills tofacilitateautomation of workflows and data processing(Hamilton liquid handlers or other automation instruments)
- Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems
- Technical experience with developing fit-for-purpose analytical characterization techniquesand drug product presentations
- Prior experience in the development ofhigh-throughput screening workflows for protein formulation development and/or analytical characterization
- Experience in managing and developing laboratory scientists, including leadinga team withinanagile podmodel
- Excellent communication and written skills
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.
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 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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