Principal Research Scientist I Parenteral Drug Product

Role Summary

The Principal Research Scientist I Parenteral Drug Product leads CMC drug product development for parenteral formulations, focusing on process development, scale-up, and tech transfer from development through commercial phases. The role involves designing and executing lab studies to create robust manufacturing processes for clinical and commercial products, generating reliable data, and collaborating across analytical, process engineering, manufacturing, quality, regulatory, supply chain, and operations teams.

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.
• Author comprehensive, scientifically sound reports (development reports or risk assessments) that serve as source documents for regulatory submissions; author portions of regulatory submissions related to these reports.
• Develop and maintain comprehensive project plans, timelines and development and/or scale up tech transfer strategy; manage technical projects at all stages of development from phase II through commercial.
• Lead cross-functional PDS&T product teams and represent the CMC team in interface with PDS&T leadership, other functions, and external partners. Participate in governance efforts such as Product Performance Teams or gate reviews.
• Prepare and review submissions through registration of the product and post-approval lifecycle management. Serve as a peer reviewer for submissions and understand regulatory submission constraints on changes.
• Establish and foster partnerships with key customers and counterpart functions to facilitate collaboration. Promote best practices among PDS&T CMC leads.
• Adhere to corporate standards regarding safety, material handling, controlled substances, GxP compliance, and applicable animal care.

Qualifications

• BS or equivalent education with typically 14+ years of experience; MS with typically 12+ years; PhD with typically 6+ years in the relevant field.
• Demonstrated ability to function as a principal investigator, generating original technical ideas and development strategies.
• Creative problem-solving abilities and willingness to champion new technologies to achieve project goals.
• Recognized as an expert in the discipline within the company or externally; evidence of leadership and influence.
• Experience as primary author of publications, presentations, regulatory documents, and/or patents; strong scientific communication and presentation skills.
• Experience presenting at leading scientific conferences.
• Strong laboratory skills and experience focusing on manufacturing process development for monoclonal antibodies, antibody constructs/conjugates, or other parenteral formulations.
• Knowledge of manufacturing controls for container closure systems (vials, prefilled syringes, prefilled cartridges).
• Solid problem-solving, experimental design, and troubleshooting skills.
• Understanding of aseptic manufacturing unit operations for liquids and lyophilized products (bulk freeze-thaw, compounding/mixing, filtration, filling, lyophilization).
• Experience with laboratory documentation systems (ELN) and technical report writing; experience with small molecule product manufacturing, development, quality, and analytics is required.
• Knowledge of FDA and global regulatory requirements for CMC issues; ability to influence internal and external experts on CMC regulatory issues independently.