Histogenics (www.histogenics.com) in Waltham MA is a tissue regeneration company developing breakthrough treatments for long-lasting joint repair.  Its cartilage regeneration products apply advanced cell biology, tissue engineering and materials science in the repair of injured or diseased joint, to restore joint function and prevent degenerative disease.

 

We are moving into Phase III of Clinical Trials and looking to add to our team.  Please join us during this exciting time! 

 

QC Analyst

 

POSITION SUMMARY:

 

Reporting to the Quality Control Manager, the incumbent’s primary responsibility will be to perform biochemical assays to support cell/tissue-based product characterization, stability and release testing. Additionally product and critical component release and stability testing will be expected and ranges in complexity from pH tests to biochemical assays to mechanical and functional tests.  The position will also require the incumbent to participate in the raw materials release testing program through inspection and internal testing as well as coordination with contract test laboratories.  The work environment is dynamic and a successful Quality Control Analyst will require cross-disciplinary teamwork, a “can-do” attitude, and the ability to be an individual contributor supporting the quality system, testing needs, and documentation whenever called upon.

 

MAJOR DUTIES AND RESPONSIBILITIES:

 

  • Perform biochemical assays to support cell/tissue-based product characterization and release testing.
  • Participate in existing assay and new assay validation and qualification activities including data and summary report preparation.
  • Assist in the transfer of methods from R&D and process development to the QC laboratory while maintaining documentation of activities as applicable.
  • Maintain timelines for scheduled stability program sample pulls and coordinate/execute performance of stability tests.
  • Perform raw material release testing in support of cGMP manufacturing inventory control.
  • Communicate activities and data analysis effectively in group meetings and in written reports where appropriate to support stability programs as well as internal process development and product characterization studies in which QC testing is required.
  • Manage QC laboratory areas by coordinating communications and follow up with outside vendors for laboratory supplies and equipment maintenance and maintaining required reagents, solutions and reference standards inventory.
  • Coordinate, ship and track test samples sent to contract laboratories as needed.
  • Responsible for the periodic review of current effective procedures, execute revisions of procedures, and draft new procedures as necessary.
  • Provide support on various other projects, as necessary, geared toward ensuring the precision, accuracy, and reliability of the GMP processes.

 

QUALIFICATIONS:

 

      Work Experience:

 

·         Minimum of two years experience in QC laboratory environment.

·         Familiarity with ISO, FDA and cGMP concepts and guidelines.

·         Experience with cell culture and aseptic technique is a plus.

 

Skills:

 

·         Strong initiative and ability to work with minimal supervision in the laboratory

·         Ability to work on complex assignments in collaboration with various departments.

·         Very strong analytical problem solving and organizational ability.

·         Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities and adapt to changes in priorities.

  • Professional, well-organized, and eager to learn and be challenged

·         Fluency in Windows and Microsoft Office (Word, Excel, Access, Powerpoint)

 

Education:

 

·         Bachelors of Science (minimum) in related discipline.

 

 

Please forward resumes to careers@histogenics.com