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: www.audentestx.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

• Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Working in a cutting-edge gene therapy environment the ideal candidate will play a leading role in independently designing and implementing a variety of molecular assays to quantify the biodistribution and efficacy of our lead AAV genetic medicines. As a key member of the Bioanalytical Science and Technology group, you will join an interdisciplinary team focused on providing crucial AAV analytics to our gene therapy programs and advancements to our patients. The position will be located in our laboratory facilities in South San Francisco, CA.

Essential Job Responsibilities:

• Independently design and implement ELISA assays, total antibody assays, antibody screening, neutralizing antibody assays, and ligand binding assay using both ELISA and ECL platforms

• Independently design and implement multiplexed qPCR or ddPCR assays to measure Vector Copy number and viral shedding in tissue from animal models dosed with AAV test articles

• Establish sensitive RT-qPCR assays to quantify exon-skipping in both in vitro/in vivo systems

• in depth proven experience in assay development and validation of neutralizing antibody assays, total antibody assays, activity assays using different AAV serotypes

• Excellent expertise in assay design and troubleshooting in performing immune assays using different platforms like ECL, Luminex, colorimetry and fluorescence based ELISA assays. ,

• Utilize robotic instrumentation to conduct routine sample processing

• Establish acceptance criteria (QA/QC) for evaluation and monitoring method performance

• Conduct comprehensive data analysis and written reports to meet tight deadlines

• Develop and qualify AAV analytics internally and transfer methods to external partners and monitor performance

• Superb data management practices in electronic lab notebooks or laboratory information management systems

Qualifications:

Required:

• PhD. in Molecular Biology, Biochemistry, Cell biology, Neurobiology or related life sciences

• Experience working in Biotechnology/Biopharmaceutical organization

• Well versed in modern immuno assays and activity assays.

• Knowledge of GLP practices and FDA guidelines in Cellular & Gene Therapy

• Authored SOPs, method development reports, method validation plans and reports thereof

• Proficiency in data analysis using softmax, GraphPad, Prism or JMP

• Exceptional attention to detail

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred:

• A completed postdoc, or industry experience 1-2+ years

• A strong record of productivity demonstrated through scientific publications

• Solid background in Biostatical analysis is a plus

• Experience in creating and refining protocols for general use in the lab (e.g., instrument use and care SOPs) and analytical procedures

• Experience in mentoring a junior level team member

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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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Category Research and Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans