Associate Director, Biologics Drug Product Development

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

Overview:

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s 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 Associate Director, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product development. 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. 

Responsibilities: 

• Serve as single point of contact for programs developed in collaboration with external partners. 
• Develop and execute robust drug product development strategies for external programs. 
• 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.   

 

• 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 working with external partners, contract research organizations and third-party manufacturers 
• Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product formulation and process development, and tech transfer 
• Extensive experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development and transfer 
• Experience as CMC cross-functional matrix team leader with strong ability to influence without authority 
• Hands-on experience with authoring regulatory filings for biologics and sterile parenteral products 
• Understanding of relevant cGMP and regulatory guidance for biologics and 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 biologics and parenteral drug product development 
• 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 

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 thisposting 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 long-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 anduntil paid and may be modified at the Company’s 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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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