- Designs and implements methods for characterizing AAV drug candidates, both internally and using CROs
- Works closely with discovery project teams and the research department process development team to ensure exploratory study material is fit-for-purpose
- Leads assessment of developability for gene therapy assets and coordinates with CMC colleagues to communicate risks and mitigation strategies and to transfer research processes and analytical methods
- In addition to gene therapy work, this role may include contributions to monoclonal antibody and peptide projects from inception to IND-enabling studies
- Maintains broad knowledge of state-of-the-art principles and theories and remains current with changes in the field and in the industry. Can quickly adapt program and portfolio goals to changes in the industry landscape
- Utilizes subject matter expertise and past experience to influence the direction of research projects including new target due diligence
- Expected to be a subject matter expert and key leader within their discipline
- Prepares detailed data reports and present results to peers, colleagues, and collaborators
- Makes significant contributions to scientific literature and conferences
- May act as spokesperson on corporate research and development and advise top management
- Participates in development of patent applications
- Interfaces with various departments and serves as internal consultant
- Works with the R&D team to design and implement a robust strategy for the growth of the biologics drug development portfolio
- Monitors the latest developments in the biologics therapy space for opportunities to in-license or acquire technologies
- Other duties as assigned
- BS/BA and 10+ years of experience in the biotech/pharmaceutical industry discovering and progressing biologic assets into clinical development OR
- MS/MA degree in biology, life sciences or related discipline. and 8+ years of experience in the biotech/pharmaceutical industry discovering and progressing biologic assets into clinical development OR
- PhD or equivalent and 5+ years of relevant experience; may include postdoc experience
- Proficient in biophysical and biochemical methods for characterizing AAV therapeutics. Strong understanding of state-of-the-art methods and technologies used in the gene therapy field. Specific techniques should include capsid titer by ELISA/Alphalisa/Octet and analytical SEC, genome titer by ddPCR/qPCR, genome integrity by gel or capillary electrophoresis, full to empty ratio by AUC/mass photometry/analytical IEX/UV-Vis methods and aggregation by DLS
- Experience with moving a gene therapy program through clinical candidate selection and into development, including preparation of documents for regulatory filings
- Well versed in gene therapy capsid and cargo design and engineering
- Knowledge of protein structure function relationships and ability to apply protein engineering principles to antibody drug design is also highly desirable
- Excellent critical analysis skills
- Ability to assimilate data and research findings outside of Neurocrine for application to new scientific projects
- Broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- Strong ability to work as part of and lead multiple teams
- Excellent leadership skills and ability, typically leads multi-level teams and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Ability to see the broader picture, impact multiple programs, teams and/or departments
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
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Sr. Principal Scientist, Biologics Research - 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:
Plays a key leadership role in developing and implementing gene therapy analytical methods for programs from early discovery research to clinical candidate selection.
Will contribute to conceptualization of gene therapies and other biologics programs that will deliver novel drugs or otherwise support our biologics drug portfolio.
Will be expected to present concepts to leadership and peers, work independently to initiate and manage multiple projects including both drug discovery and platform technologies.
Will work closely with the research, development and CMC teams to design and develop drugs utilizing multiple modalities and train team members to ensure that methods and data analysis are applied appropriately.
Expected to collaborate with external partners and internal colleagues in various aspects of biologic drug discovery and technology development._
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 $150,700.00-$218, 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.
Sr. Principal Scientist, Biologics Research professionals in San Diego
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Kristine Afanse
Business Development
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Martin Furey
Nonprofit Leadership, Development, and Operations