Associate Director / Director - Biologics Drug Product Development

AbbVie; North Chicago (IL); Sur place; USD 161 000 - 305 000; Plein temps

Résumé du poste

AbbVie Inc. in North Chicago, IL, seeks an Associate Director/Director in Biologics Drug Product Development to provide strategic oversight of ultra-high concentration formulations, process development and technology transfer across multiple pipeline programs.

The role partners with discovery, analytical and bioprocess teams to drive scalable solutions. The successful candidate will lead a team of 8–10 scientists, participate in due diligence, author regulatory submissions, and mentor

Qualifications

• Experience leading biologics drug product development in a pharma setting.
• Experience with sterile manufacturing unit operations and regulatory filings for biologics.
• 5+ years of progressive people management.

Responsabilités

• Provide strategic and technical oversight for drug product development of ultra-high concentration formulations and technology transfer.
• Oversee drug product development for 5–7 pipeline programs across stages.
• Communicate development plans, risks, and mitigations to stakeholders and management.
• Initiate scientific initiatives to drive innovation and improve processes and capabilities.
• Author high-quality technical reports and drug product sections in regulatory filings.
• Serve as subject matter expert in due diligence of external opportunities.
• Supervise and mentor a team of 8–10 scientists.

Connaissances

Scientific problem solving

Biologics drug product development

Leadership and people management

Cross-functional collaboration

Regulatory filing experience

Formation

PhD in Pharmaceutics

MS in Pharmaceutical Sciences

BS in Chemistry/Pharmaceutics

Description du poste

Associate Director / Director - Biologics Drug Product Development

• Full-time
• Salary Min: 160500
• Salary Max: 305000
• Workday Global Grade: 21
• Compensation: USD 160,500 - USD 305,000 - yearly

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.

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 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.

The role could be filled at the associate director or director level depending on the candidate's qualifications and experience.

Key Responsibilities:

• Provide strategic and technical oversight for drug product development of ultra-high concentration drug product formulation and process development and technology transfer, including fixed dose combinations for a wide range of biologics modalities.
• Oversee drug product development of a portfolio of 5-7 pipeline programs spanning early- and late-stage development, including management of external partnerships as appropriate.
• Effective and timely communication of development plans, risks, and mitigation plans to stakeholders and line management.
• Initiate and/or sponsor scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
• Accountable for the timely authoring of high-quality technical reports as well as drug product sections in global regulatory filings.
• Serve as drug product development subject matter expert in due diligence of external opportunities.
• Supervise and mentor a team of 8-10 scientists that may include technical group leaders.

This position can be hired at either the Associate Director or Director level depending on education and years of experience.

Required Qualifications:

• Director: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 18+ (Bachelors), 16+ (Masters), or 10+ (PhD) years of relevant industry experience.
• Associate Director: BS, MS, 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.
• Extensive experience in biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product development.
• Experience in sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization) development.
• Experience leading drug product development as the functional lead within cross-functional teams.
• 5+ years of progressive people management roles.

Preferred Qualifications:

• Experience with development and commercialization of ultra-high concentration liquid formulations for fixed dose combinations and drug product-device integration.
• 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 in managing third-party manufacturers of sterile parenteral products.
• Experience with quality risk management and control strategies for biologics and sterile parenteral products.
• Deep scientific knowledge and significant hands-on experience with ultra-high co-formulation development and characterization.
• 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 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, 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 and until paid andmay bemodifiedat the Company’s 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 applicants seeking a reasonable accommodation, click here to learn more:

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply