Principal Scientist, Product Development – Late Stage
- San Diego, CA
- $128,200-185,900 per year
- Training
- Full-time
Key areas of focus include: solubility enhancement, modified release dosage forms, amorphous solid dispersions (Spray Drying and Hot Melt Extrusion), self-emulsifying drug delivery systems (SEDDS), low dose/drug load product design, dry granulation, tableting, and encapsulation._Your Contributions (include, but are not limited to):Develop and optimize phase-appropriate formulations (and processes) to meet target product profile and project needsLead 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 timelinesParticipate and/or lead investigations as a SME where applicable on atypical or aberrant results on projects ranging from preformulation through to commercialIdentify, evaluate, and ensure outsourcing partners have the required expertise, capabilities, and quality/compliance standards to support drug product formulation development and process development, method development, manufacturing and packagingResearch new instrumentation, equipment, and formulation technologies to be implemented when needed for development of target formulationsPresent updates at department meetings and deliver scientific talks on current and new techniques/technology in support of formulation and process developmentCollaborate 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 launchOversee purchase, installation and maintenance of DP Pilot Plant equipment and instrumentation as lead user, and train/mentor others in the department on useAuthor development reports, protocols, memos, specifications, and other relevant documentation to allow for efficient access and retrieval by othersReview and author CMC regulatory documents, batch records, specifications, development protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirementsRepresent Product Development as "person-in-plant" during manufacturing campaigns and onsite meetings, acting as an exemplary ambassador of NBIOther duties as assignedRequirements: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 preformulation through validation, 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. Managing Contract Manufacturing Organizations. Extensive experience preparing INDs & NDAs ORMaster's degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 6+ years of similar experience noted above ORPhD in Chemistry, Biochemistry, Biology, Chemical Engineering, or related field and 4+ years of similar experience noted aboveMust have a thorough understanding of cGMPs relating to drug product manufacturing and regulatory guidelines and processes and a strong quality mindsetExtensive hands-on experience with solid dosage form manufacturing processesDemonstration of cross-functional understanding related to drug developmentMust have technical expertise in formulation development, specifically formulation of solid dosage forms such as tablets or capsulesStrong familiarity with analytical methods, validation, technology transfers and stability programs are neededAbility to analyze data sets from formulation and process development, identify trends and make data driven decidions to optimize outcomesAdvanced level knowledge of ICH, FDA, EMA guidance in CMC and Quality AreasManagement experience in strategic planning, budgets, project management plus regulatory experience in preparing and authoring the drug product sections of INDs and NDAsHolds self accountable for mistakes of self and department and can set targets and articulate resultsMust have a strong understanding of cGMPs relating to late drug product manufacturingExpert knowledge of solid oral dosage form manufacturing equipment including: mixers, blenders, mills, dry and wet granulators, fluid bed processors, twin screw extruders, spray driers, encapsulators, tablet presses, film coaters, etc.Assimilates data and research findings outside of Neurocrine for application to new scientific projectsMaintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areasMay develop an understanding of other areas and related dependenciesAdvanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/toolsAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skills (Excel, Word, Outlook, OneNote, JMP, etc)Excellent communications, problem-solving, analytical thinking skillsSees broader picture, impact on multiple programs, teams and/or departmentsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skills#LI-OB1Neurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description._ The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.