Neurocrine Biosciences
Sr. Specialist, Analytical Development Stability (Biologics)
Neurocrine Biosciences, San Diego, California, United States, 92189
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. 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
We are an equal opportunity employer. #LI-OB1 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. 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.
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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. 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
We are an equal opportunity employer. #LI-OB1 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. 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.
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