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Clinical Data Manager II

Invicro, LLC
New Haven, Connecticut, US
Remote
Temporary
Full-time

Invicro is the world’s leading translational imaging company. Based in London, Boston and New Haven. Invicro specialises in molecular and functional imaging studies to support medical and pharmaceutical research.

This is an exciting opportunity for a Microbiology Lab Technician to provide competent back-up and assistance to the microbiology activities undertaken onsite as well as providing QC Lab with routine technical support.

Invicro is involved in the development and manufacture of radioisotopes for injection into patients / volunteers, as part of clinical programmes.

The lab technician will be accountable for primary microbiology duties, including environmental monitoring, plate reading, microbiological test on water and product samples, QC testing of microbiology media etc.

as well as performing laboratory support activities for the day to day running of a busy GMP QC Laboratory. The role is full time (37.

5 hours / week) from Tuesday to Saturday.

The responsibilities include :

  • Providing support with regards to microbiology related activities at Invicro London.
  • Performing environmental monitoring in accordance with Standard Operating Procedures, policies and GMP.
  • Taking the lead in the sanitisation of cleanroom equipment (LAF cabinets, isolators, water system etc.).
  • Enumerating and reporting EM results as per defined documentation.
  • Initiate Out of Specification investigations when required and re-streak colonies for identification.
  • Submission of samples to external contract laboratory.
  • Microbiology testing (Bioburden, sterility testing, growth promotion) in accordance with relevant SOPs.
  • Preparing, Testing and Analysis of Aseptic Simulation (Media Fill) samples.
  • Taking the lead in assembling vials used for clinical production.
  • Operating to approved quality standards (e.g., GMP).
  • Providing aid / cover for the team as required and to carry out other reasonable duties as requested by the line manager.
  • Ensuring good stock control in the QC Lab and support QC Lab equipment calibration as needed (weighing balances, pH meter etc.).
  • Aiding in liquid nitrogen replenishment and waste management.

To be considered for this position you will have :

  • Education to degree level in a scientific discipline with previous practical laboratory experience (which must have been gained outside education), or extensive relevant experience in pharmaceutical microbiology.
  • Previous experience in a GxP environment desirable.
  • Good PC skills.
  • Good working knowledge of safety awareness.
  • Ability to organise own assigned activities as well as reporting issues or delays to manager.

Applicants must be able to demonstrate excellent teamworking and effective communication skills.We seek candidates who are well organized, with high levels of attention to detail, are adaptable and able to commit to flexible working patterns to support operational requirements.

Competitive Salary & Benefits

Contributory Pension, Bonus, Private Medical Insurance, Life Assurance & Flexible Benefit options

We ensure compliance with Data Protection laws and you can find our Privacy Notice on the intranet.

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

30+ days ago
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