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Laboratory Technician - Technical Development (QC/Analytical) (US-PA-Philadelphia)

Overview:

  • Performs research & development activities and assay validations as required under direct supervision. Performs analytical assays including ELISA, HPLC, electrophoresis, and spectrophotometry based methods.  Under minimum supervision, completes testing methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Works tightly with Operations for assay transfer and validations.
  • Key Accountibilities:

  • Performs assay development and validation using appropriate laboratory techniques in the biopharmaceutical testing area.
  • Conducts scientific development projects relating to the development of new assays as directed.
  • Assists in preparation and revision of technical documents and reports as directed.
  • Conducts assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Maintains laboratory notebook and follows all general and laboratory SOPs.
  • Reports observations of ongoing tests to Study Director or Area Manager.
  • Communicates with supervisor and other colleagues re: daily lab activities.
  • Orders reagents and consumables as required and uses commodity specification procedure as assigned.
  • Communicates inventory needs and material information as directed to suppliers/vendors and Materials Management personnel.
  • Prepares and maintains reagents for laboratory uses.
  • Performs laboratory maintenance and keeps records of maintenance according to guidelines and SOPs.
  • Contributes to the preparation of protocols, final reports, investigations, and deviations as needed and with supervision.
  • Completes all required training (i.e. safety, Quality Assurance, etc.).
  • Requirements:

  • Bachelor’s degree with major in Biological Sciences or science related major or equivalent training & 2 or more years of directly relevant experience required.
  • Experience with analytical & biochemical assay development is required.
  • Experience with HPLC system (preferably using Empower software) is required.
  • Experience with biologics is desirable.
  • Specialized laboratory training in general laboratory procedures is desirable.
  • Knowledge of GLP & cGMP guidelines is preferred.
  • Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.
  • Ability to record data accurately and legibly.
  • Ability to work under limited supervision at times and to handle problems.
  • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
  • Ability to perform light physical work, lifting up to 20 pounds as needed, and performing activities such as repetitive motions.