Preclinical Epilepsy Neuroscientist (I/II)
Neurona Therapeutics is a preclinical stage biotechnology company based in South San Francisco created to develop stem cell-based therapies for neurological disease. We have an opening for a Preclinical Epilepsy Neuroscientist who will contribute to ongoing programs and build new animal models to study modulation of neural circuits and support translational development of cellular therapeutics.
- Plan, design and execute studies in epilepsy and seizure models that integrate anatomical, behavioral and physiological endpoints to understand the safety and efficacy of transplanted neural cells
- Collaborate closely with a cross-disciplinary team to coordinate and drive complex studies
- Perform in vivo and histological activities required to support translational development
- Communicate results in written and oral presentations and prepare manuscripts for publication
- PhD in neuroscience (or equivalent) with demonstrated productivity in the epilepsy field as evidenced by a strong publication record
- Well-versed in developing in vivo epilepsy and seizure models for preclinical studies
- Proven ability to work as a member of an interdisciplinary team and contribute in a highly collaborative environment
- Excellent communication skills with the ability to thoroughly document and effectively present scientific data
- High energy and passion for drug discovery and development
Head of Quality Assurance
The Director of Quality Assurance will be responsible for implementing and leading all Quality programs and ensuring compliance with all relevant domestic and international regulatory guidelines as they pertain to Neurona’s cell-based product candidates.
- Drive the development of the company’s Quality strategy and policies.
- Oversee company-wide documentation practices, record keeping, training, auditing, raw material qualification and risk assessment, SOPs, batch records, study protocols, reports, investigations, analytical methods, and release specifications.
- Lead all QA efforts and documentation for the compliant manufacturing of lead product candidates. Responsible for release or rejection of GMP cell banks, reagents, and products.
- Provide Quality Assurance and compliance oversight for contract manufacturers and research organizations to ensure products/deliverables meet all required quality standards and specifications.
- Collaborate with other department heads of Process Development and Manufacturing, Preclinical Development, and Regulatory Affairs to implement proper documentation, maintain compliance, and accelerate product candidates for clinical testing.
- Draft, review, and approve relevant sections of regulatory filings.
- Represent QA department at project and leadership team meetings.
- 10+ years of experience in Quality Assurance at an operational/management level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
- Experience contributing to and reviewing regulatory filings.
- Experience with cell and gene therapies, and full understanding of FDA CBER/OTAT guidance documents and requirements.
- In-depth knowledge of pharmaceutical GMPs and ISOs (US and EU).
- Prior experience implementing quality systems and advancing novel therapeutics from preclinical stages through IND to BLA is desired.
- Effectively managed FDA inspections/audits, and conducted supplier/manufacturer audits.
- Must have excellent verbal, written, and interpersonal communication and presentation skills.
- Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive
Research Associate (Discovery Biology)
Neurona Therapeutics is an early stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological disease. Our ideal candidate is a self-motivated individual who has a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.
- Maintain human pluripotent stem cells and differentiated cells.
- Perform stem cell differentiation into neuronal lineages using a large variety of formats, from 384 well plates to regular vessels and eventually in bioreactors.
- Characterize differentiated cultures using a panel molecular biology methods (immuno cyto-chemistry, Flow cytometry, RT-QPCR).
- Conduct fluorescence-activated cell sorting, as well as magnetic sorting, experiments.
- Utilize High Content Screening (HCS) technology for high-throughput quantification of gene expression.
- Prepare tissue culture reagents (media, small molecules, cytokines); Tissue culture room upkeep and restocking.
- Maintain detailed records.
- Bachelor’s degree in cell/molecular biology or related field.
- Clear knowledge of sterile tissue culture technique (at least two years experience).
- Familiar with pluripotent stem cell culture, in vitro directed differentiation paradigms, and molecular/functional characterization of derived cell types.
- Willing to work a limited number of hours during weekends.
- Excellent writing, verbal communication, and interpersonal skills.
- Initiative to improve work processes and develop innovative scientific methodologies to enhance research productivity.
- At least one year of experience with human pluripotent (embryonic or induced) stem cell maintenance, differentiation, cell sorting and immuno cyto chemistry.
- Experience with transcript and protein-based gene expression analyses, high content screening, and lab automation technologies.
- Knowledge of bio-processes development.
- Knowledge of human developmental biology.
Research Associate (Preclinical Neuroscience)
Neurona Therapeutics is an early stage biotechnology company based in South San Francisco created to develop stem cell-based therapies for neurological disease. Our ideal Research Associate candidate is a self-motivated individual who has clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.
Responsibilities may include:
- Following experimental protocols
- Maintaining detailed and accurate records
- Analyzing data, interpreting and communicating results
- Processing tissue for histology: Microtome and cryostat sectioning, staining, immunohistochemistry, imaging and analysis
- Observation and scoring of behavioral assays
- Analyzing EEG traces
- Performing basic laboratory procedures, including handling of reagents and preparation of solutions
- Conducting independent experiments and contributing to collaborative activities
- Previous relevant lab experience and supporting references
- Strong interpersonal skills with demonstrated ability to contribute to a team
- Clear, effective written and verbal communication
- Bachelor’s or Master’s degree (or equivalent) in biology, neuroscience, or a related field
Research Associate (Process Science)
Neurona Therapeutics is an early stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.
- Prepare cells for cryopreservation and thaw frozen cryovials using aseptic techniques.
- Preparation and analysis of thawed cell samples by flow cytometry.
- Perform immunocytochemistry of thawed cell samples.
- Prepare tissue culture reagents and maintain cell cultures with aseptic techniques.
- Maintain detailed records in laboratory notebooks, templates and databases.
- Bachelor’s degree in cell biology, biology or biochemistry.
- Experience in aseptic handling of mammalian cell culture maintenance.
- Availability to work a limited number of hours on occasional weekends.
- Excellent writing, verbal communication, presentation, and interpersonal skills.
- Able to take initiative to improve work processes, develop innovative scientific methodologies and approaches to enhance research productivity.
- 2 years of industrial research experience.
- Previous experience in cryopreservation and thawing of cells.
- Strong preference will be given to candidates with experience in aseptic handling of stem cell or neuronal cell culture maintenance and differentiation.
- 1-2 years of experience in molecular biology (RT-qPCR, RNA-seq etc) and whole-cell (immunocytochemistry and flow cytometry etc) analysis techniques.
For immediate consideration, please email your resume to: email@example.com.
Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.