Associate Scientist I II, Biologics Drug Product Development

Position Description:

The incumbent in this role will support the formulation 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 requires laboratory work in areas requiring select agents and highly-potent-compound 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.
• Analyze data interpret results and draw conclusions from multistage experiments; note significant deviations and propose relevant new experiments accordingly.
• Generate high-quality data based on sound scientific understanding 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 :

• Associate Scientist I: Bachelors degree in chemical engineering biochemistry pharmaceutical sciences or equivalent with 03 years of relevant experience.
• Associate Scientist II: Bachelors degree in chemical engineering biochemistry pharmaceutical sciences or equivalent with 3-5 years of relevant experience.
• Experience in handling select agent and highly-potent-compounds is highly preferred.
• Prior experience with drug product manufacturing processes and lyophilization is required.
• Experience in CMC development with a preference for protein formulation drug delivery or analytical functions.
• Candidates must demonstrate the technical ability to execute and troubleshoot experiments using rational and critical thinking. Must be highly organized and detail oriented.
• Hands-on experience with analytical techniques used in protein characterization and stability studies such as HPLC spectroscopy HIAC DLS ELISA and Karl Fischer is preferred.
• Excellent verbal and written communication skills are required.
• A strong willingness to learn and apply new scientific techniques.

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