Scientist II, Process Development Full-time

Scientist II – Drug Product Development

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

The Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.

We have an exciting opportunity for a Scientist II to join our team. This role is an onsite, lab-based position requiring daily, hands-on scientific work and face-to-face cross-functional collaboration. The successful candidate will serve as a technical expert in biologic drug product development, with a primary focus on developing formulations to enable First-in-Human (FIH) clinical studies, supporting drug product processing and filling activities, and evaluating clinical in-use compatibility and administration. This role is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross functional interactions between scientists.

Key Responsibilities

• Act as a technical expert in biologic (mAbcs, ADCs, LNPS, toxins) drug product formulation, independently designing, executing, and interpreting formulation development studies to enable FIH and early clinical studies in a phase-appropriate manner.
• Investigate, identify, develop, and optimize formulation and drug product development approaches (liquid and lyophilized) for biologic therapeutics, continuously seeking to improve existing laboratory analytical methods and assays to accelerate development timelines.
• Routinely read and apply relevant scientific literature to inform formulation approaches; contribute to the conceptual framework of scientific reports, presentations, and patents.

• Execute drug product processing and filling activities, including hands-on operation of fillers, liquid handlers, lyophilizers, and related equipment as part of the Centralized Process Operations team.
• Independently design and conduct drug product process development studies to characterize manufacturability and ensure scalable, reproducible processes when necessary.
• Implement and innovate new experimental protocols and techniques to enhance process understanding and product quality.

• Independently design, execute, and interpret in-use stability and compatibility studies to ensure accurate and safe clinical dose administration.
• Evaluate compatibility of biologic formulations with clinical administration devices and diluents to support FIH and early-phase clinical trial requirements.
• Modify experimental plans in response to emerging project needs, in alignment with project leads and key stakeholders.

• Understand the broad objectives of the project and the role of drug product development in achieving those objectives; proactively adjust experimental plans as project priorities evolve.
• Set and meet experimental timelines through lab-based activities; demonstrate strong multitasking and planning skills in a fast-paced, deadline-driven environment.
• Understand CMC and drug product development requirements; work efficiently and collaboratively across functions toward project timelines and goals.
• Learn, understand, and master new experimental techniques; act as a resource for colleagues.
• Generate high-quality data based on sound scientific principles; document results thoroughly in an electronic lab notebook.
• Effectively organize and present scientific plans and data in team meetings, formal presentations, and written reports.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance where applicable.

Qualifications

• Bachelor's Degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, or equivalent with typically 7 or more years of relevant industry experience; or Master's Degree or equivalent education with typically 5 or more years of industry experience.
• Demonstrated experience in biologic formulation development for liquid and/or lyophilized drug products.
• Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
• Hands-on experience with drug product processing and filling equipment (e.g., fillers, liquid handlers, lyophilizers).
• Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand, and master new experimental techniques and independently troubleshoot issues in the lab with good judgement.
• Detail-oriented and highly organized, with a strong ability to solve technical challenges.
• Ability to multitask and work within timelines, with strong planning and analytical skills.
• Excellent oral and written communication skills; ability to maintain detailed records in an electronic lab notebook.
• Ability to work collaboratively within and across scientific teams.
• Demonstrated scientific writing skills, including authorship of reports, presentations, and/or patents.

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.