Scientist l - Biologics Drug Product Development

The Scientist I - Biologics Drug Product Development will support the formulation development of protein biologics from early development (pre-clinical/First-In-Human candidates) with a specific focus on neurotoxins for therapeutics and aesthetic use. 

This position requires laboratory work in areas requiring select agents and Toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. 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 to support animal studies. 

• Conduct clinical in-use studies to guide dose solution administration. 

• Interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments. 

• Generate high-quality data based on sound scientific principles and prepare formulation data summaries technical reports and scientific presentations. 

• Support functional technical initiatives by investigating and developing novel experimental approaches and/or technologies in the field of drug product development. 

• Maintain oversight of day-to-day laboratory activities; manage inventory of raw materials and drug product packaging and manufacturing supplies; coordinate ordering shipping and receiving. 

Qualifications :

Minimum Qualifications:

• Bachelors with a minimum of 5-7 years OR Masters with a minimum of 2-4 years of experience in pharmaceutics pharmaceutical sciences chemical engineering analytical sciences or equivalent field in the biotechnology industry

• Experience with formulations in particular

• Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC spectroscopy SEC HIAC MFI DLS ELISA Karl Fisher). 

Preferred Experience:

• Prior experience with drug product manufacture processes and lyophilization is a plus 

• CMC development experience in protein formulation drug delivery or analytical functions is preferred. 

Other Required Skills:

• Excellent communication skills required. 

• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking.

• Candidates must be highly organized and detail oriented. 

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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