Associate Principal Scientist, Preclinical Development

About the role

The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics & Biopharmaceutics Team within Sterile Product Development.

Responsibilities

• Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis
• Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
• Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.
• Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.
• Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.
• Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.
• Leads project activities at external manufacturing sites including tech transfers
• Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development,