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.astellasgenetherapies.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
Process Science department in Astellas Gene Therapies (AGT), the Center of Excellence in Astellas Pharma., have an opportunity for a Scientist I to develop and establish the downstream process for rAAV which meets our quality target product profiles based on a deep understanding of complex manufacturing process. S/he implements experiments with assignments of broad complexity spanning scientific points, PD engineering, instrumentation and manufacturing process/scale up of rAAV. Through the development of rAAV manufacturing processes that reduce the cost and improve the quality, AGT will bring our gene therapy products to the patients and their families immediately.
Responsibilities
Develops and evaluates new downstream process by utilizing and/or combining existing technologies within the industry according to AGT’s strategy
Conceives and evaluates novel and innovative technology applicable to purify and polish AAV product
Plans experimental designs based on the knowledge of physicochemical properties of biopharmaceuticals with appropriate sampling and analytical definition
Performs design of experiment investigations using software tools for design and data analysis
Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters
Assists development of robust and cost-effective commercial scale production processes.
Writes protocols, development reports, and other technical reports to ensure that results are properly archived and communicated
Ensures safe and compliant Good Laboratory Practices and laboratory safety procedures are followed
Regularly presents data, findings and conclusions to program teams and sub-teams
Proactively collaborates with consultants and internal stakeholders (Research, PD, AD, Manufacturing, Quality, etc.).
Establishes and fosters relationships with contract organizations.
Required Qualifications
Advanced degree in Biology or Engineering with 5+ years relevant biopharmaceutical industry experience
Comprehensive experiences and knowledge of development of biopharmaceuticals products
Success designing and executing experiments to answer scientific questions.
Proven ability to effectively create, communicate, and gain support for execution plans and strategies with a wide range of stakeholders
Excellent collaboration, problem solving team player with great communication skills including negotiation and conflict resolution skills.
Able to work in a fast-paced and dynamic environment with competing priorities
Successful experience working cross-functionally across multiple departments including Research, Manufacturing, and Quality.
Experience working with external vendors, institutions, and other collaborators to develop and/or evaluate new and disruptive technologies
Seeks opportunities to improve existing processes and drive large-scale change that positively impacts organizational success.
Operational and experimental knowledge using liquid chromatography systems and other downstream-related skids not only for the lab but pilot scale systems
Operation and experimental knowledge for filtration processes including normal and tangential modes
Performs design of experiment investigations using software tools for design and data analysis
Excellent and effective written, verbal communication and presentation skills.
Positive, professional attitude with a passion for science.
Business English level
Preferred
Prior rAAV gene therapy experience
Experience with authoring IND, CTA, and other related regulatory filings and responding to Agency feedback/inquiries
Experience with tech transfer into GMP facilities/labs
Working Conditions
Salary Range
Benefits:
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
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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