- Leads the activities associated with the development and execution of methods relevant to protein and gene therapy products for analytical development in a Research and Development environment
- Authors and reviews the documents for the development and establishment of analytical methods for product characterization to support research and development activities including the in-process and release testing for material manufactured for research and IND-enabling studies
- Is a SME during discussions with Research, Development, and collaborative stakeholders to build scientific knowledge, capabilities, and strategies by providing gene therapy and therapeutic protein product characterization data to support research and product development decisions
- Actively leads the contribution to, and assures, the development of, and effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects from discovery to clinical development
- Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions
- Prepares clear and concise technical reports and participates in project team discussions
- Executes on strategy, vision, and direction set by line management
- Contributes to the decision-making processes within the project team by actively engaging in scientific and technical discussions
- Performs other duties as assigned
- BA/BS in Biochemistry, Biology, or other relevant discipline and 10+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR
- MS/MA in relevant discipline and 7+ years as noted above OR
- PhD or equivalent and 5+ years as noted above
- Knowledge of protein and gene therapy biology with a good understanding of testing/characterization methods required
- Experience with biophysical and biochemical methods in AAV characterization (e.g. SEC-MALS, SEC-FLD, SEC-AEX, ddPCR, DLS, AUC, CE-SDS) required
- Good knowledge of cell-based methods associated with bioanalytical analytical method development (e.g. TCID50, Potency assay, viral transduction, and ELISA methods) preferred
- Familiarity with product and analytical processes such as Quality by Design (QbD) and Quality Risk Management (QRM) tools to support Clinical Manufacturing at the Dev Candidate stage in a phase-appropriate fashion, to support CMC is a plus
- Familiar with laboratory operations, including instrument set up, maintenance, and safety
- Familiar level knowledge of the biologics drug development process is recommended
- Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus
- Demonstrates solid level of understanding project / group goals and methods for characterizing and testing AAV-based gene therapy and other protein therapeutics
- Assimilates data and research findings outside of Neurocrine for application to new scientific projects
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- 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
- Ability to work as part of a team; may train lower levels
- Excellent computer skills
- Strong communications, problem-solving, analytical thinking skills
- Detail oriented yet can see broader picture of scientific impact on team
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Strong project management skills
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Principal Scientist, Gene Therapy Analytical Development - San Diego, United States - Neurocrine Biosciences Inc.
Description
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, but few options.
What We Do:
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options.
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVieAbout the Role:
Leads the design, development, and application of methods for the production and characterization of AAV gene therapy and other biologic-based development candidates for research, pre-clinical, and clinical use.
Leads the laboratory-based analysis of the physico-chemical and biological properties of proteins and gene therapy vectors and establishes the laboratory standards to determine identity, strength, purity, potency and quality for research and development candidates.
_Your Contributions (include, but are not limited to):
Requirements:
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
We are committed to building a diverse, equitable, and inclusive workplace, 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 $125,700.00-$182, 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.
