Senior 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

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVies R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy).

AbbVie is seeking a highly motivated candidate for the position of Senior Scientist II, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM). This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants and third-party manufacturers.

Key Responsibilities

• Lead matrix drug product teams for one or more internal and external projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Lead the design and execution of biologics drug product formulation development, characterization and robustness studies.
• Serve as subject matter expert in biologics predictive stability modeling, in-use and administration procedures, and QRM.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
  
  
  

Qualifications

• Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 12 (Bachelors), 10 (Masters), or 4 (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experienceleading drug product development as the functional lead within cross-functional teams
• Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, and QRM.
• Strong experience in predictive stability modeling (statistical, phenomenological and mechanistic, and/or AI/ML) for biologics.
• Strong experience in in-use compatibility and stability for biologics products.
• Strong experience in quality risk management.
  
  
  

Preferred Qualifications

• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer.
• Experience in managing third party manufacturers of sterile parenteral products.
• Experience with quality risk management and drug product control strategies.
  
  
  

Key Competencies

• Deep scientific knowledge and significant hands-on experience with predictive stability modeling, administration procedures and risk management.
• Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
• Builds strong relationships with peers and cross-functional partners to enable higher performance.
• Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
• 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 manages innovation to reality.
  
  
  

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 thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,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 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 employeeremainsin the Company's sole andabsolutediscretion unless anduntil 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.

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