Sr. Scientist, Product Dev - Late Stage

Role Summary

Participate in developing and executing formulation and process design & engineering to support development projects from Phase I through commercial. Partner, with a Quality by Design (QbD) mindset in full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, process development, scale-up engineering and optimization, packaging and stability testing of oral solid drug products. Ensure product quality, scalability and regulatory compliance. Develop CDMO relationships to support clinical programs. Assist with successful technical transfer for Neurocrine drug products to CDMOs. Participate within project teams to deliver high-quality, phase-appropriate drug products that address molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile.

Responsibilities

• Formulation Design and Optimization: Partner in designing and developing robust formulations for solid oral dosage forms (e.g., tablets, capsules), focusing on optimizing for stability, bioavailability, and manufacturability performance.
• Process Development: Partner in developing and optimizing manufacturing processes, including powder mixing, blending, granulation, compression, and encapsulation, to help define critical quality attributes (CQAs) and critical process parameters (CPPs).
• Scale-Up Support: Partner in formulation and process scale-up efforts from lab scale to pivotal and commercial scales, assisting with seamless technology transfer to CMO partner sites.
• Project Team Participation: Participate in weekly or bi-weekly NBI-CMO project team meetings and provide Pharm Dev-specific updates on progress.
• Regulatory Documentation: Contribute to authoring and reviewing sections of drug product documentation to support various regulatory submissions.
• Deviation Investigation: Support investigations as a subject matter expert (SME) on atypical or aberrant results for projects ranging from pre-formulation through commercialization.
• Outsourcing Support: Assist in evaluating outsourcing partners and ensuring they have the required expertise, capabilities, and quality/compliance standards for drug product formulation development and manufacturing.
• Commercial Product Support: Support Continuous Process Improvement (CPI) and Continuous Process Verification (CPV) for commercial products as needed, including troubleshooting technical challenges.
• Technology Research: Research new instrumentation, equipment, and formulation/process technologies to be implemented for development of target formulations.
• Departmental Collaboration: Support and participate in presentations at department meetings on current and new techniques/technology in support of formulation and process development.
• Cross-Functional Collaboration: Collaborate effectively with internal Product Development, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain colleagues, as well as external CDMO partners.
• Equipment Maintenance: Participate in the purchase, installation, and maintenance of DP Pilot Plant laboratory equipment and instrumentation.
• Report Writing: Author development reports, protocols, memos, specifications, and other relevant documentation to allow for efficient access and retrieval by others.
• Quality and Compliance Review: Review CMC regulatory documents, batch records, and development protocols to ensure scientific integrity and compliance. On-Site Representation: Represent Product Development as "person-in-plant" during manufacturing campaigns and onsite meetings.
• Other duties as assigned

Qualifications

• BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field AND 5+ years of pharmaceutical industry experience in a pharmaceutical product development laboratory setting; experience in solid dosage form development, and preferably with solubility enhancement, modified release, and/or pediatric dosage forms. Experience with conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc. OR
• Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred AND 3+ year of similar experience noted above OR
• Ph.D. AND some similar experience noted above
• Must have solid understanding of cGMPs relating to drug product manufacturing, and a strong quality mindset
• Hands-on experience with solid dosage form manufacturing processes
• Demonstration of cross-functional understanding related to drug development
• Must have technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsules
• Familiarity with analytical methods, validation, technology transfers and stability programs
• Holds self accountable for mistakes of self and department and can set targets and articulate results
• Must have a good understanding of cGMPs relating to late drug product manufacturing
• Strong knowledge of conventional solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.
• Demonstrates solid level of understanding project / group goals and methods
• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
• Able to explain the process behind the data and implications of the results
• Strong knowledge of scientific principles, methods and techniques
• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Ability to work as part of a team
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Effective report writing and oral presentations skills are required
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• Ability to creatively solve complex problems in a team environment

Education

• Details listed in Qualifications (BA/BS; MS or PhD as applicable)