Job Description

Performs any basic to complex Cell Potency and Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects. Performs and thoroughly documents Research & Development activities as required.

The work schedule for this role is Sunday - Thursday: 10:00am - 6:30pm

• Conducts any basic to complex Cell Potency and Analytical assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Accurately completes Test Methods and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
  • Follows all general and laboratory SOPs
  • Conducts critical review of results and reports data to Technical Reviewer or supervisor
  • Communicates with supervisor and other colleagues re: daily lab activities
  • Prepares reagents and completes reagent batch records
  • Checks reagents for expired chemicals and disposes of any expired reagents
  • Performs laboratory maintenance (i.e. decontaminates and disposes of medical and other waste as appropriate, maintains laboratory supply inventories, keeps work surfaces clean and neat) and keeps records of maintenance according to guidelines and SOPs
  • Performs routine equipment monitoring and cleaning (i.e. centrifuges, biosafety and chemical hoods, refrigerators, incubators and freezers) and keeps records according to guidelines and SOPs
  • Orders reagents and consumables as required and uses commodity specification procedure as assigned
  • Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.)Contributes to the preparation of Protocols, Testing Records and Final Reports, as needed and with supervision. Revise existing SOPs as assigned by Management Author investigations and deviations with minimal supervision
  • Demonstrates proficiency in scientific theory and applies scientific rigor in the laboratory
  • Correctly analyzes scientific data with accuracy and precision
  • Performs daily work activities with minimal supervision
  • Communications inventory needs to Materials Management personnel and contacts suppliers for technical information as needed
  • May be required to work Holidays and weekends
  • May be required to work Overtime

• High School diploma and over 6 years of relevant experience or
  • Associates’/Bachelor’s (science preferred) degree with over 3 years of relevant or equivalent experience

 Knowledge / Skills / Abilities:

• Strong Technical and Scientific knowledge of cell culture and protein based assays (i.e. ELISA, cell culture, etc).
  • Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Plate Readers, Automated cell counters, Microscopes, etc.
  • Shows excellent time management skills
  • Ability to record data accurately and legibly.
  • Ability to understand and follow verbal and demonstrated instructions.
  • Ability to clearly express and exchange ideas by means of verbal and written communication.
  • Ability to work effectively as part of a team and exhibit effective interpersonal skills.

  Physical Requirements:

• Must be able to work in Lab setting with Biohazards /various Chemicals
  • Must be able to wear appropriate PPE.
  • Must be able to work in environment with variable noise levels.
  • Ability to stand or sit for long periods of time.
  • Ability to perform light physical work, lifting up to 20 pounds as needed.
  • Ability to crouch, bend, twist, and reach.
  • Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
  • Must be able to perform activities with repetitive motions.
  • Inside working conditions.

Advanced Therapies  

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.”

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