Scientist Quality Control
Integrity Bio, Inc. (IBI) is a contract development and manufacturing organization, specializing in biologics formulation development and drug product manufacturing.
The Scientist's key responsibilities are to develop, transfer, and execute analytical methods to support Quality Control testing (in-process, lot release, and stability). This individual will develop analytical methods and standard operating procedures for use in a CGMP environment, and to perform analytical characterization and product testing to support both CGMP Operations. The Scientist will be responsible for the maintenance and troubleshooting of instrumentation, including but not limited to UPLC / HPLC, and electrophoresis systems (gel and capillary). The position requires knowledge and understanding of both standard and state-of-the-art analytical instrumentation and technologies, and this individual will be expected to recommend the same to meet the company’s goals and improve its efficiency. The Scientist will also serve as a member of project teams, in a leadership role as needed, which will require substantial interaction and communication with client company representatives. The ability to communicate technical information, both verbally and written, and to work efficiently to meet defined timelines is crucial. This position will require direct interaction with staff in both CGMP and Research & Development, and may supervise Quality Associates or Lab Assistants.
We are seeking an individual with industrial experience in analytical sciences or CGMP quality control. Candidates with a Bachelor’s or Master’s degree in biochemistry, analytical chemistry, life sciences, or a related field, should have 8-10 years of industrial experience. Candidates with a Ph.D. should have 2-4 years of industrial experience after post-doctoral work.
Essential requirements include:
- Experience in the analysis of proteins, monoclonal antibodies, and/or peptides
- Development of analytical methods for use in the support of process/formulation development and/or CGMP (in-process, lot release, stability)
- Responsibility for the maintenance of Analytical Instruments
- Experience working and communicating within multi-disciplinary teams, especially with clients and subcontractors
- Development and execution of capillary electrophoresis methods, CE, CIEF, etc.
- Development and execution of small molecule analytical methods
- Transfer of analytical methods between development and CGMP labs
- Supervision of scientific/technical staff and management of scientific/technical functions
The following experience is highly desirable:
Additional consideration will be given to candidates who have worked in environments requiring CGMP training. Experience in the development and management of scientific project timelines is also advantageous.