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
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.
Be BOLD (Find a Way)
Care Deeply – for our patients, each other and our work
#GSD (Get Stuff Done)
Analyst I QC Microbiology will be responsible for implementing and executing microbiological testing in support of clinical and commercial products in compliance with GMP requirements. This role will also support testing for stability studies, methods validation studies and equipment validation.
Perform release, stability, and in-process testing supporting production activities. Testing includes, but is not limited to, bioburden, endotoxin, pH/conductivity
Perform growth promotion/media qualification
Perform plate reading, generate microbial isolates, and Gram stain
Author/revise technical reports and laboratory procedures
Perform testing in support of method transfer/verifications
Assist in data trending and summarization
Assist with equipment qualification/validation studies; perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP
Participate in deviation and OOS investigations
Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
Receive, unpack and organize supplies for QC areas
The Analyst I, QC Microbiology, will be responsible for ensuring clinical and commercial products are in GMP compliance through microbiological testing.
BS. degree in Microbiology or other science related degree with 0-2+ years of relevant industry experience in a quality control role
Demonstrated experience of aseptic technique and common microbiological testing
Knowledge of relevant compliance and guidance documents
Must be able to gown into cleanrooms in support of testing and manufacturing activities
Good documentation and data organization
Detail oriented and willingness to learn
Strong interpersonal skills which contribute to a supportive and positive work environment
Highly collaborative team player with the ability and willingness to support other colleagues in the Quality Control department.
Must be capable of observing and adhering to lab safety standards and procedures
Successfully performs routine work independently with minimal instructions
Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment
This role is scheduled to work during normal business hours, typically starting at 8:00 AM, Monday – Friday; flexibility to cover off-shift work may be required
Will support and demonstrate quality standards to ensure data of highest quality
Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Prior experience in GMP QC environment (minimum 1 year)
Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries is strongly desired
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 35lbs
Maybe gowned inside the cleanroom for extended periods of time.
Use of a respirator may be required. Exposure to biohazards and viruses.
This is an on-site role working in a cGMP regulated manufacturing facility
On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
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 Sandford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans