Sr. Specialist, Analytical Development Stability (Biologics)

Who We Are

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About The Role

Leads moderate complex stability programs with minimal supervision for development stage pharmaceutical biologic compounds (drug substances and drug products). Reviews stability protocols, reports, and data contract service organizations (CSOs). Supports shelf-life/retest dating, data trending, and specification revision for drug substances and drug products. Conducts work in compliance with safety and regulatory requirements.

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Your Contributions (include, But Are Not Limited To)

• With minimal supervision, leads stability programs for development-stage pharmaceutical biologic products (drug substances and drug product) for ICH, bulk hold, patient in-use, cycling studies, etc.:
• Tracks stability test schedules at contract service organizations (CSOs)
• Reviews and/or approves stability protocols
• Reviews, summarizes and trends stability data with statistical software such as SLIMStat
• Determines shelf life or retest periods
• Generates stability protocols, reports, and presentations for review
• May sit on and in some cases, lead multiple stability programs with moderate complexity within CMC
• Coordinates communication with internal customers and external vendors
• Reviews and approves specifications, change controls, out-of-specification (OOS), out-of-trend (OOT) and deviation reports
• Facilitates investigations for out of specification and out of trend results in stability studies
• Authors and/or reviews Department SOPs related to stability programs
• Authors and/or reviews appropriate development reports and stability related sections of regulatory filings, such as INDs, IMPDs, NDAs, etc.
• Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed
• Serves as a stability representative for a CMC project team or a working group
• Assists in method development and validation activities as needed
• Provides training and mentoring to junior staff, as needed
• Performs other duties as assigned
  

Requirements

• Bachelor's degree in Chemistry or other life science and 4+ years of analytical experience in the pharmaceutical industry or relevant industry experience OR
• Master’s degree in Chemistry or other life science and 2+ years pharmaceutical industry experience OR
• PhD in Chemistry or other life science and some pharmaceutical industry experience preferred
• Good knowledge in biologic stability protocol design under different storage conditions, packaging configurations, and climatic zones
• Good knowledge in trending biologic quality attributes such as degradation products and shelf-life extension
• Good knowledge of biologic product specifications, method validation and transfer
• Some previous biologic stability management and analytical data review experience preferred
• Experience in communicating with CSOs
• Working knowledge of formulation development for injectable products
• Working knowledge of DS process development
• Familiar with degradation pathways and forced degradation studies
• Familiar knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1
• Knowledgeable of standard analytical techniques for biologics (HPLC, bioassays, ELISA, CE-SDS, iCIEF, SEC, IEC, LC-MS)
• Knowledgeable of document management systems
• Familiar with bulk hold, patient in-use, and cycling studies
• Demonstrates level of understanding project / group goals and methods
• Consistently recognize anomalous and inconsistent results and interprets experimental outcomes
• Excellent oral and written communication skills with strong interpersonal skills
• Competency in Word, Excel, PowerPoint and statistical analysis software such as JMP, SLIMStat, or Minitab
• Contributes to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration
• Experienced user for document management systems such as Veeva Quality and Veeva RIM
  
  

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 don’t line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $95,100.00-$138,050.00. 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 20% 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.