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Sr QC Analyst/QC Analyst - Microbiology

Employer
Instil Bio
Location
Tarzana, California, US
Salary
Competitive
Closing date
Dec 6, 2021

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Sector
Academic / Research
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
ABOUT InstilBio

InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patients own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.

We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.

Sr QC Analyst/QC Analyst Microbiology

InstilBio is seeking a driven and experienced Senior QC Analyst or Analyst Microbiology in the Quality Control organization. The successful candidate will help implement and maintain the Environmental Monitoring (EM) program with related contamination control programs in compliance with regulatory requirements and commitments for clinical and commercial products. The individual will work closely with a cross-functional team (e.g. Manufacturing, Facilities and Quality Control- analytical, Quality Assurance etc.) to contribute to risk assessments and investigations. Additionally the candidate will provide product testing support for microbial assays.

In this role, the QC Analyst Microbiology will be expected to be knowledgeable in EM, Personnel Monitoring, Gowning Qualification, product testing, GMP regulation, lab investigation, AOQ and APV as it related to QC Microbiology. This position is based in Thousand Oaks, CA and will require occasional domestic and international travel. This role will report in to the Quality Control Supervisor.

Responsibilities (include but not limited to):
  • Perform Environmental Monitoring program testing including EMPQ and routine testing in compliance with regulatory requirements and commitments for clinical and commercial products
  • Execute internal product testing including growth promotion, bioburden, rapid sterility and endotoxin
  • Support external microbial ID send out
  • Support EM trending
  • Support SOP and document creation
  • Support LIMs establishment
  • Ensure well written investigation reports
  • Report and investigate out-of-specification results, deviations, CAPAs in timely manner to ensure appropriate immediate actions are taken
  • Support internal and external audits, as necessary.
  • Maintain and operate equipment and instruments in the QCM laboratory
  • Interface with cross-functional groups such as manufacturing, facilities, supply quality, quality assurance

Basic Requirements
  • BS in Microbiology or related Life Sciences
  • 2+ years in a GMP environment (pharmaceutical or biotechnology industry)
  • At least 1 year of prior supervisory or lead experience preferred.
  • Experience in aseptic techniques and cleanroom operations
  • Solid interpersonal, organization and problem-solving skills
  • Knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to microbiology
  • Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment
  • Ability to work in a fast-paced environment
  • Ability to support weekend work, as necessary
  • Occasional domestic and international travel required
  • Travel to support U.K. lab operation as necessary

Preferred Requirements
  • LIMS experience

The company requires that all new employees be fully vaccinated against Covid-19 (except for those who require reasonable accommodations for medical or religious reasons, or as required by applicable law).

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