Purpose:

The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead, specifically for parenteral drug product process development and 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 product development and CMC teams 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. Implement and may innovate 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 of comprehensive, scientifically sound reports, e.g. development reports 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 development and/or scale up tech transfer strategy; technical projects at all stages of development are included, from phase II clinical through commercial.
• Lead cross-functional PDS&T product teams and 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.

Preferred Qualifications:

• Strong laboratory skills and experience focused on manufacturing process development for monoclonal antibodies, antibody constructs/conjugates or other parenteral formulations.
• Knowledge and experience with manufacturing controls for container closure systems, 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 technical report writing.Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.
• Ability to influence internal and external experts on CMC regulatory issues, independently.
• Demonstrated excellence in writing, presentation, and overall communication.