TEMP Senior Scientist, Bioanalytical Outsourcing

Neurocrine Biosciencesis a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering developing and commercializing life-changing treatments for patients with under-addressed neurological psychiatric endocrine and immunological disorders. The companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons disease classic congenital adrenal hyperplasia hyperphagia in Prader-Willi syndrome endometriosis* and uterine fibroids* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information visit and follow the company onLinkedInX Facebook and YouTube. (*in collaboration with AbbVie)

Responsible for all aspects of bioanalytical method development validation and sample analysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Working with Preclinical Operations establish contracts and work orders for bioanalytical projects. Work with Clinical Pharmacology and Clinical Operations to plan and track bioanalytical method development validation and sample analysis to support study initiation execution and reporting. Ensure CROs capture and deliver on important expectations and agreed-to tasks in support of Neurocrines clinical development programs.

• Oversee all aspects of bioanalytical method development validation and sample analysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards for small and large molecule development

• Work with R&D Operations and legal departments to establish contracts and work orders for bioanalytical projects

• Oversee sample transfer and tracking from clinical sites or central lab to bioanalytical CROs

• Ensure CROs are provided with requisite supplies and information to conduct sample analysis including provision of reference and internal standards CoA recertification and statement of work completion

• Plan and track critical reagent preparation bioanalytical method development validation and sample analysis activities to meet data requirements according to study protocols and timelines

• Review bioanalytical validation plans protocols and bioanalytical data to ensure alignment with current regulatory requirements

• Attend regular meetings with CROs to facilitate updates. Capture important expectations and agreed to tasks in post-meeting minutes and share minutes with CROs and hold them accountable

• Provide routine status updates to NBI Clinical Clinical Pharmacology QA Accounting and Data Sciences colleagues

• Review data transfer protocols ensure proper data format investigate data discrepancies and support data consolidation

• Presents data and recommendations to internal and external stake holders

• Other tasks as assigned

• BS in Pharmacokinetics Pharmaceutical Sciences clinical pharmacology or a related scientific discipline and 4 years of experience in clinical-stage pharmaceutical development OR

• MS in Pharmacokinetics Pharmaceutical Sciences clinical pharmacology or a related scientific discipline and 3 years of similar experience noted above OR

• PhD in Pharmacokinetics Pharmaceutical Sciences clinical pharmacology or a related scientific discipline and some relevant experience as noted above

• Hands-on experience with the development validation and troubleshooting of the bioanalytical methods and clinical sample analysis for small and large molecules

• Knowledgeable on current relevant regulatory guidance / regulations (ICHM10)

• 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 one or more scientific disciplines becoming expert in one discipline

• Strong knowledge of scientific principles methods and techniques

• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Detail oriented yet can see broader picture of scientific impact on team

• Excellent computer skills

• Ability to meet multiple deadlines with a high degree of accuracy and efficiency

• Strong project management skill

• Excellent problem-solving and analytical thinking skills

• Strong written presentation and verbal communication skills

• Proactive innovative with good problem-solving skills

• Ability to work as part of a team; may train lower levels

The pay you should reasonably expect to receive is $53.27 $77.21 per hour. Decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and skills.

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Neurocrine 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 dont line up to exactly what we have outlined in the job description.