Get Biology JobsGet Biology Jobs

Investigator Initiated Research (IIR) Associate II

  • Unicon Pharma
  • 02/14/20
  • Andover, MA
  • 01810
  • 29.00 / Hourly
  • Contractor
Job Description:
The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Andover Site Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. This position will report to the Manager of Investigations within the Site Operations Management Function.

The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.

The individual will be expected to develop collaborative relationships with the operational leadership and staff in each suite and the appropriate Quality and Functional Area representatives in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations. Experience with and in depth understanding of cell culture and chromatography is highly desirable. They will be expected to assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.

Additional responsibilities and expectations include:
Have a fundamental understanding of the investigation process as it applies to manufacturing issues
Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical. Be able to use that knowledge to investigate process deviations and atypical results and identify root cause
Work with the appropriate people from both the quality and operational organizations develop a corrective action
Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards
Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results

A BS or MS, preferably in a scientific or engineering discipline preferable. A minimum qualifications to BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required. Prior experience with investigations including conducting and writing investigations and in use of continuous improve methodology preferred. The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.

Employer Information

Browse other Biology Jobs in Massachusetts

  1. Medical Technologist

    Concord, MA
    Job Summary Performs a variety of routine and specialized diagnostic laboratory tests on environmental, blood and body fluid speci...
  2. Teach Science in England - Sep 2020 start date

    Cambridge, MA
    Quantum Scholars are delighted to announce that our UK government supported and funded program has been extended by another 2 year...
  3. Research Fellow-Motyl Lab

    Scarborough, ME
    The Motyl Lab is hiring a postdoctoral research fellow to work with a friendly and supportive team investigating interactions betw...
  4. Eating Disorder Psychologist - San Francisco, CA

    Boston, MA
    Vivo HealthStaff has been retained to find Mental Health Clinicians for a large healthcare organization based in San Francisco. Th...
  5. Head of Assay Development (HTS)

    Boston, MA
    Head of Assay Development (HTS) ... Boston High Throughput Screening ... Genetic Engineering ... Assay Development ... Enzymology...
  6. Molecular Science Liaison

    Boston, MA
    Description Job Title: Molecular Science Liaison (MSL) Position Summary MS Ls are responsible for communicating the value of Caris...
  7. Patent Analyst

    Boston, MA
    Description Global Prior Art, a Boston-based intellectual research services company, is offering a position to work as an Analyst...
  8. Software QA/DevOps Engineer

    Canton, MA
    Universal Sequencing, a biotech startup headquartered in Canton, MA (~15 miles southwest of Boston) with a location in Carlsbad, C...
  9. Biomedical Laboratory Officer

    Nashua, NH
    Biological tests are an important part of determining the diagnosis and treatment of disease. Responsible for directing the servic...
  10. Laboratory Technician

    Boston, MA
    Lab Technician Greater Boston Area Our client, an exciting biomedical startup, is seeking a highly motivated and independent lab t...