Senior Scientist II

Company Description

About AbbVie

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The PDS&T Parenteral Product Development group is seeking a motivated Scientist for a drug product process lead role, specifically for parenteral drug products and focused on process development, commercial site scale up, and tech transfer. The candidate will independently design and execute lab studies to develop robust manufacturing processes for clinical phase and commercial products. This person will generate and analyze precise, reliable, and reproducible data in a timely manner, independently or under the direction of a more senior scientific leader. This position will be an integral part of the CMC product development team and is highly collaborative across functions such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing Sites.

Responsibilities: 

• Independently design and conduct critical experiments that further project goals. May innovate by using new experimental protocols/techniques for parenteral DP characterization studies to enable process scale up.
• Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
• Tech transfer activities for parenteral DP from development scale up to clinical/commercial scale.
• Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches.
• Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
• Authoring comprehensive, scientifically sound reports, e.g. development reports and/or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health authorities related to these reports.
• Develop and maintain comprehensive project plans, timelines, and tech transfer strategy of technical projects at all stages of development; included, from phase I clinical through post commercial launch activities.
• Lead PDS&T product teams and may represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for submissions and understand how regulatory submissions limit operational changes.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration. Identify and promote best practices among PDS&T CMC leads.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

Qualifications

• Bachelors, Masters, or PhD in chemical engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines with typically 12+ years of experience; MS or equivalent education with typically 10+ years of experience; PhD with typically 4+ years of experience.
• Strong laboratory skills and experience focused on manufacturing process development for monoclonal antibodies, antibody drug conjugates, or other parenteral formulations.
• Knowledge and experience with aseptic parenteral manufacturing, including vials, prefilled syringes, and prefilled cartridges.
• Scientific problem solving, experimental design, and trouble shooting skills.
• Solid understanding of the various unit operations of aseptic manufacturing for liquid and lyophilized products such as bulk freeze/thaw, compounding/mixing, filtration, filling, and lyophilization.
• Experience in laboratory documentation systems, including ELN, and demonstrated experience with techn