Principal Scientist, Prod Dev - Late Stg

Neurocrine Biosciences-posted 3 months ago
$128,200 - $185,900/Yr
1,001-5,000 employees
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Design, develop and execute formulation and process design & engineering to support development projects from Phase I through commercial. Manage, with a Quality by Design (QbD) mindset, 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. This role involves designing and implementing innovative formulation strategies and robust process engineering to ensure product quality, scalability and regulatory compliance. Establish CDMO relationships to support clinical programs. Oversee successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC 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.

  • Design and develop robust formulations for solid oral dosage forms (e.g. tablets, capsules), optimizing for stability, bioavailability and manufacturability using QbD principles
  • Develop and optimize manufacturing processes, including but not limited to powder mixing/blending, granulation, compression, coating and encapsulation to define critical quality attributes (CQAs) and critical process parameters (CPPs)
  • Lead formulation and process scale up from lab scale to pivotal and commercial scales ensuring seamless technology transfer to CMO partner sites
  • Participate and/or lead weekly or bi-weekly NBI-CMO project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines
  • Author and review Module 3 sections of drug product to support various regulatory submissions
  • Participate and/or lead investigations as a SME where applicable on atypical or aberrant results on projects ranging from pre-formulation through to commercial
  • Identify, evaluate, and ensure outsourcing partners have the required expertise, capabilities, and quality/compliance standards to support drug product formulation development, process design & engineering and associated manufacturing with a line of sight of commercialization
  • Support Continuous Process Improvement (CPI) and Continuous Process Verification(CPV) for commercial products as needed including troubleshooting technical challenges and site redundancy efforts
  • Research new instrumentation, equipment, and formulation/process technologies to be implemented when needed for development of target formulations
  • Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of formulation and process development
  • Collaborate effectively with Product Development Early Stage, Chemical Development, Analytical Development, Clinical, Quality, Regulatory, and Supply Chain colleagues and external/CDMO partners to efficiently advance projects from Phase IIb through commercial launch
  • Participate in purchase, installation and maintenance of DP Pilot Plant laboratory equipment and instrumentation as needed, lead/train/mentor others in the department on use
  • Author development reports, protocols, memos, specifications, and other relevant documentation to allow for efficient access and retrieval by others
  • Review CMC regulatory documents, batch records, specifications, development protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirements
  • Represent Product Development as 'person-in-plant' during manufacturing campaigns and onsite meetings, acting as an exemplary ambassador of NBI
  • Other duties as assigned
  • BA/BS degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 8+ years of experience in the pharmaceutical industry in a late phase product development setting.
  • Experience with solid dosage form development from pre-formulation through validation, and preferably with formulation and process design & engineering experience using QbD framework including DoE.
  • Experience with conventional solid oral dosage form unit operations and manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, encapsulators, tablet presses, film coaters, etc.
  • Managing Contract Manufacturing Organizations.
  • Extensive experience preparing INDs & NDAs OR Master's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 6+ years of similar experience noted above OR PhD in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field preferred and 4+ years of similar experience noted above
  • Must have a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong quality mindset
  • Expert level knowledge and hands-on experience in solid oral dosage formulations and related manufacturing unit operations of small molecules
  • Expert level experience in using statistical analysis software and risk assessment tools to implement the Quality by Design (QbD) elements during product life cycle
  • Ability to analyze data sets from formulation and process, identify trends and make data driven decisions to optimize outcomes
  • Advanced level knowledge of ICH, FDA, EMA guidance in CMC and Quality areas
  • Demonstration of cross-functional understanding related to drug development
  • Strong familiarity with analytical methods, validation, technology transfers and stability programs are needed
  • Holds self accountable for mistakes of self and department and can set targets and articulate results
  • Must have a strong understanding of cGMPs relating to late drug product manufacturing
  • Expert 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.
  • Knowledge of the following instrumentation and techniques is preferred; HPLC, Solubility Analysis, DSC, TGA, PXRD, Particle-Size Analysis, GVS, PLM, T3, and SEM
  • Assimilates data and research findings outside of Neurocrine for application to new scientific projects
  • Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
  • May develop an understanding of other areas and related dependencies
  • Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
  • Ability to work as part of and lead multiple teams
  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
  • Excellent computer skills
  • Excellent communications, problem-solving, analytical thinking skills
  • Sees broader picture, impact on multiple programs, teams and/or departments
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
  • Excellent project management skills
  • Retirement savings plan (with company match)
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits to include medical, prescription drug, dental and vision coverage
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