Quality Control Senior Associate, QC Microbiology
3 weeks ago
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As a QC Microbiology Senior Associate, you will report to the Director QC Microbiology, and perform microbial testing of product and environmental monitoring of controlled areas within the Manufacturing facility at the Bothell site.
What you'll do
* Conduct Environmental Monitoring the production facility
* Perform personnel monitoring to support Aseptic Gowning Qualification
* Incubate and enumerate colony growth and subculture organisms
* Coordinate and manage sample shipments to approved external contract laboratories for microbiological testing, including bacterial or fungal identification
* Review and report data results from external contract labs
* Perform data entry into approved repository
* Perform Microbiological and Environmental Monitoring trending and author reports as per schedule
* Manage bacterial growth media and plate inventories, testing materials, standards, components and consumables to ensure testing execution to planned schedules
* Execute bioburden enumeration assays and endotoxin measurement assays
* Accurately complete documentation and report results, including any potential excursions and non-conforming results to departmental management in a timely manner
* Collaborate with area owners to investigate environmental excursions, and implement corrective actions
* Maintain equipment and instruments and coordinate preventive maintenance and calibrations
* Execute microbiological method qualifications and verifications protocols
* Maintain the QC lab including periodic cleaning of incubators, biosafety cabinets, cold storage chambers, and the lab
* Train personnel in and qualify personnel for aseptic gowning
* Adhere to and promote laboratory health and safety requirements
What we're looking for
* Familiar with the US, EMA, and ICH regulations and guidance documents including aseptic guidance such as Annex 1
* Good working knowledge of microbiological assays, pharmaceutical microbiology, aseptic technique and performing work in biosafety cabinets or laminar flow hoods
* Experience with aseptic gowning and cleanroom operation activities
* Experience in contamination control strategies
* Good working knowledge of aseptic processing
* Experience with GMP Quality/Compliance systems
* Collaboration skills
* BA or BS degree in Microbiology, life science or biochemistry
* 1-2 years' experience in the pharmaceutical or biotechnology industry in a Microbiology, Quality or Compliance function
What will separate you from the crowd
* Performing cleanroom work in sterile gowning
* Experience with writing SOPs, change controls and lab investigation reports
* Experience with facility qualification activities
What you should know
* There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing
* The base pay range for this position at commencement of employment is expected to be between $70,000 to $85,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
* Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
* Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
* Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
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