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
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)
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 Senior Analyst, Quality Control Microbiology will support Quality Control testing of drug substances and process intermediates in support of clinical development and commercial programs. This position will be located in South San Francisco.
* Support Quality Control testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines
* Perform bioburden, endotoxin, pH/Conductivity and other tests as needed
* Perform viable air, non-viable particulate, surface/swab environmental monitoring (EM) of manufacturing areas
* Perform sampling and testing for gas, utilities and purified water
* Perform growth promotion/media qualification, Gram staining and microbial cryopreservation
* Perform plate reading, generate microbial isolates, and shipping of isolates for identification
* Receive, unpack and organize supplies for QC areas
* Revise SOPs, Forms and approved documents
* Perform/support deviation and OOS investigations, as needed
* Support the identification and implementation of effete CAPAs
* Support testing and assist in writing of method validation, assay development, routine, and non-routine study protocols
* Support Fill and Finish operations
* Assist in data trending and summarization
* Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance to cGMP
* Perform data review and microbial assessment
* Support special projects and continuous improvement efforts
* Provide training and technical leadership to less experienced staff
* Bachelor's Degree in chemistry, biology, or microbiology with 5+ years' relevant microbiology laboratory experience in Pharmaceutical/Biotech.
* Excellent knowledge 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 (ALCOA +) and data organization
* Detail oriented and willingness to learn and follow instructions
* Interpersonal skills and ability to contribute to the success of a team
* Proven history of working in a fast-paced team environment, time management, and meet deadlines.
* Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed
* Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required
* 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
Physical Demands and Work Environment
Must be proficient in use of computer, particularly Microsoft Word and Excel programs, and be able to sit/stand and be gowned inside the cleanroom for extended periods of time. Some lifting required (not more than 50 lbs.). Ability to tolerate the smell of Gram negative organisms and disinfectants (i.e. 1% bleach, sporeklenz) may be needed. Use of a respirator may be required. Exposure to biohazards and viruses. Routinely able to stand, walk, kneel and crouch while performing sampling, such as environmental monitoring.
This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. Other responsibilities and task may be assigned.
* 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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled