Associate Scientist II, Biologics Drug Product Development Full-time

Job Opportunity

The incumbent in this role will support the formulation & process development of protein biologics for clinical stage molecules with a specific focus on highly potent molecules 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:

• Design and 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 in vivo studies.
• Conduct clinical in-use studies to guide dose administration.
• 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.
• Accurately document and report experiments in full compliance with GSP standards

Qualifications:

• BS with a minimum of 3-5 years or MS with a minimum of 0-2 years of industry experience in pharmaceutics, pharmaceutical sciences, chemical engineering, analytical sciences, or equivalent field in the biotechnology industry. This opportunity will not consider applicants with a PhD.
• CMC development experience in protein formulation, drug delivery, or analytical functions is preferred.
• Candidates must exhibit the technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail oriented.
• Hands-on experience with analytical techniques used for protein characterization and stability studies (e.g HPLC, CE-SDS, spectroscopy, HIAC, MFI, DLS, ELISA, Karl Fisher) are preferred.
• Prior experience with drug product manufacturing processes and lyophilization are desirable.
• Excellent communication skills are required.

Additional Information:

• Candidates based in Southern California are encouraged to apply. Relocation assistance is not guaranteed for those not living in a commutable distance to Irvine, CA or willing and able to self-relocate.
• 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

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Pay Range: $58656 – 110500 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.