- Develop bioanalytical assays including analyzing samples from in vivo studies, Developing and validating assays and managing outsourcing activities for biomarker clinical assays gene therapy products.
- Lead bioanalytical assays development activities for gene therapy products.
- Assay development, validation, and analysis of non-clinical study samples in both GLP and non-GLP setting.
- Proficient experience in immunogenicity assays such as Total antibody and Neutralizing antibody studies and immune assays such as ELISA and ELISpot in both non-GLP and GLP setting.
- Evaluate bioanalytical assay development status on several gene therapy projects and make timely decisions on assay development activities.
- Report project status (development plans, timelines) to supervisor and technical teams.
- Write tech transfer and development reports.
- Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
- Attend training sessions to maintain and increase skills and knowledge of GLP's and safety awareness.
- Follow relevant Operating Procedures while developing bioanalytical assays using ddPCR, Luminex, Real time PCR, KingFisher, etc.
- Ability to work with external CROs and guide the development and validation of bioanalytical assays
- PhD in Biochemistry, molecular biology or cell biology with technical expertise in molecular and immune assay development and minimum 6 years industry experience in biopharma development with a primary focus on the development and validation of bioanalytical methods.
- Proven expertise with a range of immune and molecular methodologies consistent with ICH guidelines for bioanalytical characterization of AAV products.
- Extensive experience in ELISA, ECL, ELISPOT, QPCR, QRT-PCR, RNAseq, ddpcr, methodologies
- Successfully designing experiments, analyzing data and making decisions based on results from neutralizing antibody assay, total antibody assay, VCN viral shedding and biodistribution from tissue samples, is required.
- Prior history in compiling and analyzing data and generating reports which is routinely presented to project teams to enable decision making and writing for regulatory filings.
- Success in transfer of validated methodologies to manufacturing consistent with project timelines and regulatory expectations.
- A clear and organized thought process, with attention to detail and a high quality work ethic are essential.
- Prior experience in Fluorescence in situ hybridization (FISH) and RNA foci detection
- designing in vivo and invitro ligand activity assays for AAV products.
- Experience with mass spectrometric analyses of biologics.
- This is onsite position located in South San Francisco.
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
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Principal Scientist, Bioanalytics - South San Francisco, United States - Astellas Pharma
Description
Principal Scientist, Bioanalytics
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website:
The Role
Reporting to the Director, Bioanalytical Development, Principal Scientist, Bioanalytics is responsible to develop, optimize, and qualify a variety of bioanalytical methods and use the qualified methods to analyze animal samples from non-clinical GLP and Non-GLP studies for different programs to evaluate efficacy and assess safety endpoints to support decision making. Principal scientist, Bioanalytics is also responsible for developing clinical assays and work with external collaborators and CROs for successful validation of assays.
Responsibilities
Required Qualifications
Preferred
Working Conditions
Salary Range: $153,000 - $204,000 (NOTE: Final salary could be more or less, based on experience)
Benefits:
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
