Scientist I, Biologics Drug Product Development

The incumbent in this role will support the formulation and process development of protein biologics from early development (pre-clinical/First-In-Human candidates) through commercialization with a specific focus on highly potent compounds for therapeutics and aesthetic use. This position involves designing executing and reporting of laboratory experiments to advance the development of stable and effective biologic formulations. The incumbent will collaborate across multidisciplinary teams and contribute to solving technical challenges in both formulation and process optimization to enable successful clinical and commercial progression of therapeutic biologics.

This position requires laboratory work in Biosafety level 2 laboratories. Therefore the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics environmental health and safety financial human resources and general business policies requirements and objectives.

Responsibilities

• Execute formulation composition and drug product process development studies for sterile liquids lyophilized and pre-filled dosage forms.
• Manufacture drug product formulation batches for evaluating formulation stability and/or for animal studies.
• Conduct clinical in-use studies to guide dose solution administration.
• Perform analytical testing and characterization of biologic samples assessing critical quality attributes to support formulation and process decisions.
• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments.
• Thoroughly document experimental procedures results and interpretations in laboratory notebooks and reports ensuring compliance with company and regulatory standards.
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries technical reports and scientific presentations.
• Participate in the evaluation implementation and ongoing improvement of new and existing technologies techniques and equipment to continuously enhance formulation and process development.

Qualifications :

• BS with a minimum of 5 years or MS with a minimum of 2 years of experience in pharmaceutics pharmaceutical sciences chemical engineering analytical sciences or equivalent field in the biotechnology industry
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Candidates must be highly organized and detail oriented.
• Hands-on laboratory experience in biologics formulation development drug delivery drug product manufacturing processes lyophilization or analytical functions is preferred.
• Prior hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment is strongly desired.
• Strong organizational and documentation skills; ability to maintain accurate experimental records and reports.
• Effective verbal and written communication skills with the ability to work collaboratively in cross-functional teams.

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 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. 

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 Companys sole and 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