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)THE ROLE
Reporting to the Senior Manager, Downstream Process Development, this position will contribute to the design, development, and optimization of the processes for manufacture of our Adeno-Associated Virus (AAV) vectors for human gene therapy. The Senior Process Development Engineer, Downstream will be responsible for the design and implementation of processes, instrumentation, and equipment from the laboratory through pilot plant and manufacturing scales, as well as assisting the manufacturing operation in problem solving with regards to equipment and systems. This is a hands-on laboratory-based position located in South San Francisco.
RESPONSIBILITIES
Plan, execute, and analyze lab scale/pilot scale experiments to evaluate new process technologies.
Experience with scale up/scale down, and tech transfer to manufacturing.
Maintaining digital records of all activities using in-house systems and shared digital document repositories.
Use of statistics to design experiments and analyze data
Generate technical reports to summarize results of evaluations
Ensure safe laboratory operations and good documentation practices
Contribute to planning operations and scheduling activities
Critically review external vendor offerings applied to viral vector and plasmid production
REQUIRED QUALIFICATIONS
Masters degree in Chemical Engineering, Biochemical Engineering, Cell Biology, or other relevant field with 10+ years relevant biopharmaceutical industry experience, or a BS degree with 12+ years relevant biopharmaceutical industry experience.
Prior successful experience operating lab scale chromatography and filtration systems
Proven ability to take direction and work independently in a fast paced environment
Positive, professional attitude with a passion for science
Outstanding collaboration, problem solving team player with excellent communication and organizational skills
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 QUALIFICATIONS
Familiarity with gene-based therapies and specifically AAV and DNA plasmid production.
Analyzing data using statistical software, specifically JMP
Expertise in single-use systems and technology
Experience with scale-up and scale-down activities
Understanding of cGMP requirements
Experience mentoring or training junior staff
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
#LI-LK1
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans