Scientist II, Biologics Drug Product Development

Job Description

Within the Biologics CMC Development organization, the incumbent will support the development of formulations, manufacturing processes, and testing of protein biologic drug products. We support projects from early development through commercialization, with a specific focus on select agents for therapeutic and aesthetic use. This position requires laboratory work in areas requiring select agents (i.e., Biosafety level 2 laboratories).

The ideal candidate will have hands-on experience with analytical techniques used for protein characterization and stability testing, as well as a demonstrated ability to drive innovative science in a team setting. Experience with laboratory automation, automated sample preparation, high-throughput screening, instrument integration, or automated data workflows is highly desirable.

Responsibilities

• Plans and executes product formulation & process development activities in support of the development of new products intended for new biologic entities and life-cycle management of marketed products with a focus on highly potent biologic drug products.
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.
• Participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.
• Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie drug products.
• Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development and raising visibility within the scientific community through external presentations and publications.
• Develop and implement laboratory automation systems and workflows to support high-throughput formulation screening, analytical testing, data generation, and process optimization while improving efficiency, reproducibility, and data quality.

Qualifications

• BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+ years of experience (Pharmaceutical Sciences, Analytical Sciences, Biochemistry and Molecular Biology, Chemical Engineering degree, preferred).
• A strong technical background encompassing protein formulation principle and characterization approaches
• Hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment, highly preferred.
• Candidates with hands-on experience in analytical techniques used for protein characterization and stability testing will be preferred (e.g., SPR, DLS, MFI)
• Prior experience with Surface Plasmon Resonance (SPR) for screening and assessing formulation stability is preferred. The ideal candidate will have experience using SPR-generated data to evaluate protein stability and support formulation development and optimization.
• Prior experience with sustained release formulation development including characterization is preferred.
• Prior experience in the development of liquid protein product formulations in vial as well as lyophilization expertise is desirable.
• Prior experience with aseptic processing and drug product manufacturing process tech transfer is preferred.
• Prior experience with automation, data analysis, and high-throughput approaches in protein formulation, characterization, stability testing, or manufacturing processes is preferred.
• Candidates must be detail-oriented and highly organized.
• Demonstrated ability to drive innovative science and solve complex problems is highly preferred.
• Excellent communication and writing skills

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute…