Scientist l, Biologics Drug Product Development

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 at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug conjugates (ADC), and other biologics using state of the art formulation and process technologies. We create valuable intellectual property via new formulation compositions, cost effective manufacturing processes, and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

We are seeking a motivated and experienced Scientist for biologics drug product formulation and process development. The candidate will independently design and develop stable and robust drug product formulations and scalable manufacturing processes for biologics used in both clinical trials and commercial products. This individual will be an integral part of the drug product development and CMC teams. The position is highly collaborative across functions such as preformulation, analytical, process engineering, internal and external manufacturing, Operations S&T, and Commercial Manufacturing. The individual will work to define formulation and manufacturing processes for a range of biologic drug products.

Key Responsibilities:

• Design and execute the formulation and drug product development activities of the assigned compounds. This will include formulation and commercial process development for biologics (monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins).


• Perform lab-based studies including study design, preparation, execution, data collection, analysis, presentation, and report writing.


• Partner with manufacturing sites to enable smooth technical transfer from lab to pilot to commercial scale.


• Generate original technical ideas for formulation and process technologies for assigned biologics.


• Integrate into assigned pipeline project teams as a key contributing member. Actively participate on cross-functional teams within Biologics Development.


• Stay current with relevant scientific literature and lead new scientific initiatives. Publish scientific papers and external presentations to influence the pharmaceutical industry.


• Prepare concise and sound scientific presentations of experimental results.


• Authoring of comprehensive, scientifically sound reports, e.g . development reports or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health authorities related to these reports.


• Maintain absolute compliance with all relevant work safety and quality requirements.



 
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Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Minimum Qualifications:

• Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with 5+ (Bachelors), 2+ (Masters), or 0+ (PhD) years of relevant industry experience.


• Strong laboratory skills and experience focused on formulation and process development for monoclonal antibodies, antibody constructs/conjugates or other biologics.


• Scientific problem solving, experimental design, and trouble shooting skills.


• Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization for liquid and lyophilized products.


• Experience in laboratory documentation systems, including ELN, and experience with technical report writing.



 
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Key Leadership Competencies 

• Effectively communicates to influence others and pulls together ideas from disparate areas.


• Builds strong relationships with peers and cross-functional partners to maximize performance.


• Creates a learning environment and is open to suggestions and experimentation for improvement.


• Embraces the ideas of others, nurtures innovation, and manages innovation to reality.


• Enhances our culture by modeling inclusive leadership and team-oriented behaviors.


• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks, identify problems and work toward solutions rapidly, and maintain a productive mindset amongst change.  



 
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Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s 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.