Scientist II, Biologics Drug Product Development
About The Position
Within AbbVie’s Biologics CMC Development organization, the Scientist II supports development of formulations, manufacturing processes, and testing for protein biologic drug products. The work supports projects from early development through commercialization, focusing on select agents for therapeutic and aesthetic use. Laboratory work includes work in select-agent areas, such as Biosafety Level 2 laboratories. The role involves protein formulation and characterization, stability testing, drug product process development, and generating high-quality scientific data. The scientist contributes to drug product development teams, collaborates with CMC members and other AbbVie stakeholders, and develops innovative experimental approaches and technologies. The position also develops and implements laboratory automation systems and workflows for high-throughput formulation screening, analytical testing, data generation, and process optimization.
Requirements
- Bachelor’s degree or equivalent education with typically 7 or more years of experience, or master’s degree or equivalent education with typically 5 or more years of experience.
- Strong technical background in protein formulation principles and characterization approaches.
- Detail-oriented and highly organized.
- Excellent communication and writing skills.
Nice To Haves
- A degree in Pharmaceutical Sciences, Analytical Sciences, Biochemistry and Molecular Biology, or Chemical Engineering.
- Hands-on experience working with highly potent compounds in a Biosafety Level 2 laboratory environment.
- Hands-on experience with analytical techniques used for protein characterization and stability testing, such as SPR, DLS, or MFI.
- Experience with Surface Plasmon Resonance (SPR) for screening and assessing formulation stability, including using SPR-generated data to evaluate protein stability and support formulation development and optimization.
- Experience developing and characterizing sustained-release formulations.
- Experience developing liquid protein product formulations in vials and expertise in lyophilization.
- Experience with aseptic processing and drug product manufacturing process tech transfer.
- Experience with automation, data analysis, and high-throughput approaches in protein formulation, characterization, stability testing, or manufacturing processes.
- Demonstrated ability to drive innovative science and solve complex problems.
Responsibilities
- Plan and execute product formulation and process development activities for new biologic entities and lifecycle management of marketed products, with a focus on highly potent biologic drug products.
- Generate high-quality data using sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.
- Participate in drug product development teams and contribute to planning and execution of development studies according to project goals and timelines.
- Interact with CMC members and other AbbVie stakeholders to support successful drug product development.
- Investigate and develop novel experimental approaches or technologies in drug product development, and raise scientific visibility through external presentations and publications.
- Develop and implement laboratory automation systems and workflows for high-throughput formulation screening, analytical testing, data generation, and process optimization, improving efficiency, reproducibility, and data quality.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility for short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
