Principal Scientist I, Biologics Drug Product Development Full-time

Senior Scientist II / Principal Scientist I

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:

• 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.
• Experience leading 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.

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.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Recruitment Fraud Alert

• AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
• If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

Protect yourself by verifying job offers and communications. Your safety is important to us.

Pay Range: $109500 – 208500 USD

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.