Principal Research Scientist II, Biologics Drug Product Development

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 Principal Research Scientist II located in North Chicago IL. We are seeking an accomplished scientist with a proven track record in biologics drug product process development modeling scale-up and tech transfer. 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 the early-stage biologics drug product process development group in Lake County IL
• Accountable for drug product process development scale-down modeling process simulation manufacture of technical batches and process scale-up and tech transfer for early-stage biologics and sterile parenteral programs.
• Initiate and/or support scientific initiatives to drive innovation continuously enhance capabilities and platforms and improve business processes.
• Serve as a drug product team leader for one or more projects and represents Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Effectively and timely communicate development plans risks and mitigation plans to stakeholders and line management.
• Support due diligence for business development opportunities.  
• Manage a team of 4-5 scientists and engineers (BSc to PhD level) including other drug product team leaders.
• Responsible for performance management development plans and recommendations for promotions and transfers for direct reports.

Qualifications :

• Bachelors Masters or PhD in Pharmaceutics Pharmaceutical Sciences Chemistry Chemical Engineering or related disciplines with 16 (Bachelors) 14 (Masters) or 8 (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Strong experience with biologics (proteins conjugates peptides and/or neurotoxins) parenteral synthetic molecules and/or genetic medicine (AAV LNPs cell therapy) drug product process development.
• Extensive experience with sterile manufacturing unit operations (freeze-thaw compounding mixing filtration and filling) characterization scale-down models simulation scale-up technology transfer and batch record authoring.
• Experience as CMC cross-functional matrix team leader
• Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
• People management experience

Preferred Qualifications:

• Biologics drug product formulation development
• Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
• Experience in managing third party manufacturers of sterile parenteral products
• Experience with quality risk management and control strategies for biologics and sterile parenteral products

Key Competencies:

• Deep scientific knowledge and significant hands-on experience with drug product process development and tech transfer
• 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 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 thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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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Work :

No

Employment Type :

Full-time