Associate Scientist, Analytical Development
Job Location:
San Diego, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Who We Are:
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)
About the Role:
Under direct supervision is responsible for development and execution of analytical test methods that facilitate drug product development / manufacturing and regulatory submissions for clinical study introduction through phase III trials. Activities includes test method development qualification/validation transfer and execution. Supports late stage troubleshooting and development of products processes and methods in support of product commercialization.Your Contributions (include but are not limited to):
With direct supervision develops and executes chemical and instrumental methods (e.g. HPLC GC TGA DSC MS FTIR Water Content) of analyses of drug product development compounds
Accurately follows established test methods procedures and pharmacopeia chapters (e.g. Dissolution Content Uniformity) to generate data essential for strategic decision making
With direct supervision plans and executes forced degradation informal stability and excipient compatibility studies
With direct supervision and as appropriate assists/leads the development of analytical methods investigations for out of specification out of trend and/or anomalous results
With direct supervision collaboratively plans and executes cross functional studies for formulation development
Recognizes and responds to unexpected or anomalous observations in all activities
Maintains complete and accurate records of laboratory work in conformance with company SOPs and training
Provides detailed reviews of peer generated data as well as that generated from contracted service providers
Other duties as assigned
Requirements:
BS/BA degree in chemistry or closely related field and some relevant industry experience preferred; Experience with Empower a plus
Working knowledge of data systems for computer-controlled instrumentation
Familiarity with performing analytical testing of solid oral drug products; Hands-on knowledge preferred
Knowledge of conducting HPLC analysis and troubleshooting. Working knowledge of performing stability indicating method development a plus
Familiarity with performing dissolution analysis and troubleshooting. Hands-on knowledge performing dissolution method development a plus
Understanding of analytical data evaluation and ability to draw meaningful conclusions
Ability to present analytical data clearly and demonstrate knowledge of the testing and the product
Knowledge of cGMP expectations for laboratory records and quality systems
Knowledge of ICH guidance and common testing per USP chapters
Knowledge of statistical analysis a plus
Ability to provide ideas for process improvements
Able to execute experiments efficiently and suggest small process improvements
Able to recognize patterns or inconsistencies in data results
Able to deduce meaningful results while conducting routine analyses or troubleshoot minor issues. Good knowledge of one scientific discipline
Developing knowledge of scientific principles methods and techniques
Good knowledge and some experience working with discipline specific laboratory equipment/tools
Ability to work as part of a team
Good computer skills
Developing communications problem-solving analytical thinking planning and organization skills
Detail oriented
Understands importance of meeting deadlines
Proficient using MS-Excel MS-Word
Ability to work with a team of individuals to meet goals
Ability to accomplish tasks in a timeline driven setting
#LI-LS1
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.
The hourly rate we reasonably expect to pay is $35.35-$47.34. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and addition this position offers an annual bonus with a target of 15% 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.
Required Experience:
IC
About Company
Neurocrine Biosciences is dedicated to providing breakthrough treatments for patients in need with rare and under-addressed diseases.
