Quality Control Microbiology Supervisor - Cell Therapy
Company: ImmPACT Bio
Location: Camarillo
Posted on: May 12, 2022
Job Description:
ImmPACT Bio is a clinical-stage company, headquartered in the
Los Angeles area, and with a subsidiary in Israel, developing novel
cell therapies for treating cancer. The company's next-generation
chimeric antigen receptor (CAR)-T cell technologies are based on
Boolean logic-gate approaches and address key biological challenges
for engineered T cell therapies including relapse due to antigen
loss/escape; on-target, off-tumor toxicities; and the
immunosuppressive tumor microenvironment.
ImmPACT's lead program, a bispecific "OR-gate" CAR, with an
excellent tolerability profile, has demonstrated durable complete
remission (CR) in 88% of patients treated so far.
ImmPACT Bio provides a generous rewards package, with competitive
compensation and health benefits, with career progression benefits
as part of a rapidly growing multi-platform company.
ImmPACT-Bio is seeking a Quality Control Microbiology Supervisor to
support our new T-cell therapy GMP clinical manufacturing facility
in West Hills, CA.
You will work with the Quality Control team in supporting our
efforts in this exciting new area of cancer immunotherapy. This
role will be a hands-on resource reporting to the Director of
Quality Control. In this role you will be responsible for the
day-to-day oversight of the QC Microbiology main functions;
Environmental Monitoring (EM)/ Utilities Monitoring (UM) and
Microbiology Testing. You will be responsible for the environmental
monitoring program, utility testing, incoming testing of media and
final product microbiological testing, as needed.
Primary Responsibilities:
- Supervision of all QC Micro laboratory testing
- Maintain environmental monitoring program for the site and
on-time release of product lots to patients
- Management of the aseptic gowning training and qualification
program
- Support internal and external audits
- Maintain and support of QC Microbiology Associate training
- Assemble reports on findings from cGMP facility/utilities, as
needed. Implement corrective action plans when necessary and
frequently update management on environmental trends
- Complete routine record review of test data and related
documents for in-process and routine environmental monitoring
testing, drug product release. Generation of CoAs for product
release
- Develop, revise and review SOPs, qualification/validation
protocols and reports
- Conduct EM excursions investigations as Subject Matter Expert
(SME).
- Conduct investigations regarding out of specifications (OOS)
results and address and manage deviations related to micro
procedures and processes
- Monitor the GMP systems currently in place to ensure compliance
with documented policies
- Review proposed changes to systems, procedures, methods, and
submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of
areas of responsibility
- Conduct performance management of direct reports and have
regular development discussions
Qualifications:
- Master's Degree and 3+ years of Microbiology experience OR
Bachelor's Degree and 5+ years of Microbiology experience OR High
School Degree and 9+ years of Microbiology experience
- Demonstrated leadership and management skills, including
establishing direction and goals, and building good work ethics for
the team
- Minimum of 5 years' experience working in the Environmental
Monitoring and Microbiology laboratories in an aseptic sterile
manufacturing facility is preferred.
- Minimum of 3 years' experience supervising/managing
microbiology and environmental monitoring labs within the
biotechnology or pharmaceutical industry
- Experience in the application of microbiological techniques
such as air monitoring, surface monitoring, genus and species
identification of various microbes, endotoxin testing and sterility
testing of final product.
- Candidate should be well versed in various microbiological
techniques including rapid release methods, and qualifying
environmental monitoring processes with reference to cell therapy
product
- Proficient in MS Word, Excel, Power Point and other
applications
- Excellent interpersonal, verbal and written communication
skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with
minimal direction and able to adjust workload based upon changing
priorities
- Ability to be flexible with schedule, and work overtime as
needed
- Working knowledge of SOP writing and SOP change request is a
plus
- Able to follow instructions and SOPs precisely and able to
make/keep accurate documentation
- Detail-oriented with good written and verbal communication
skills
- Good organizational and planning skills, and an ability to work
efficiently
- Able to seek and accept input from more senior team members for
the performance of assignments as needed
- Team player with good interpersonal skills
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the
discovery of transformative chimeric antigen receptor (CAR) T-cell
therapies for cancer patients who have exhausted their treatment
options. The company's logic-gate-based CAR T platforms address key
biological challenges in treating cancer. ImmPACT Bio's
technologies are specifically designed to prevent antigen escape,
prevent 'on-target - off-tumor' toxicities, and overcome the
immunosuppressive tumor microenvironment.
Powered by JazzHR
4cB76PhnrP
Keywords: ImmPACT Bio, Camarillo , Quality Control Microbiology Supervisor - Cell Therapy, Healthcare , Camarillo, California
Didn't find what you're looking for? Search again!
Loading more jobs...