Lead Investigator

The Investigations group is responsible for overseeing investigations for all GMP manufacturing suites, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacturing, GMP Laboratory (including Analytical and Microbiology) and all associated support services.

RESPONSIBILITIES:

- Coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations, and deviations for all analytical assays.
- The candidate will be responsible for leading thorough, detailed and timely investigations, and the generation of high quality and timely investigation reports detailing the root cause of the deviation and the preventive action that needs to be taken to prevent a reoccurrence.
- Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards.
- This position will report to the Manager of Investigations within the Site Technical Services.

SKILLS/QUALIFICATIONS:

- The ability to facilitate cross functional collaboration is a critical component of this role. As such the individual will be expected to develop mutually collaborative relationships with the operational leadership and staff in each of the manufacturing suites and the various quality control laboratories.
- The candidate will be expected to have experience and in-depth understanding in the area of cell culture and bioreactor operations as well as protein chromatography and filtration.
- It would also be highly desirable to have an understanding or awareness of the principles of quality assurance in a biological manufacturing environment and a working knowledge of compliance and the appropriate regulations.
- Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical.
- Ability to exercise appropriate judgment in developing practices, techniques and evaluation criteria for progressing an investigation in compliant manner.
- A BS or MS in a scientific or engineering discipline preferable.
- A minimum of 2 years experience for an MS or 5+ years for a BS in a Biopharmaceutical and/or biological manufacturing operation with a strong technical background in the relevant scientific disciplines as well as cGMP and Quality environment is required.
- Prior experience with investigations including conducting and writing investigations and in programs such as Operational Excellence and Six Sigma preferred.
- Must be a collaborative team player with strong coordination, facilitation and writing skills.
- Technical Writing, Data Research; interviewing as part of DMAIC; Six Sigma are the most critical skills for this position.
- Cell/Tissue Culture