Principal Scientist I, Biologics Drug Product Development

AbbVie Inc.; Chicago (IL); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Benefits package

Long-term incentive programs

Résumé du poste

AbbVie Inc. in North Chicago, IL, seeks a Senior Scientist II / Principal Scientist I with proven biologics drug product formulation and process development expertise. You will lead scale-up, tech transfer, and cross-functional collaboration to advance product presentations and CMC activities.

The role emphasizes execution, innovation, and partnerships with discovery, analytical, and manufacturing teams to deliver robust drug products for biologics and genetic medicines.

Qualifications

• BS/MS/PhD in relevant field with years of industry experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics and gene therapy products.
• Experience leading drug product development within cross-functional teams.

Responsabilités

• Represent Bio DPD in cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Communicate development plans, risks and mitigations to stakeholders and management.
• Support scale-up and technology transfer activities to internal/external sites.

Connaissances

Biologics formulation

Tech transfer

Cross-functional collaboration

Scale-up

Formation

BS/MS/PhD in Pharmaceutics/Pharma Sci

Outils

Regulatory filings knowledge

Description du poste

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 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 Senior Scientist II / Principal Scientist I, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product formulation and process development, 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:

• Represent 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 scale-up and technology transfer activities to internal and external manufacturing sites.
• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.

Qualifications

Qualifications:

• BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with
  • Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
• Experienceleading drug product development as the functional lead within cross-functional teams

Preferred Qualifications:

• Hand-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

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 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 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 only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html