Senior Analytical Scientist - Pharmaceutical Product and Process Development
Ben Venue Laboratories (BVL) is seeking a Senior Analytical Scientist for their Product and Process Development (PPD) group for their state-of-the-art pharmaceutical manufacturing facility in Bedford, OH (Cleveland Metropolitan Area).
DUTIES AND RESPONSIBILITIES:
The Senior Analytical Scientist will:
- · Work within the PPD in BVL Generics, BVL Joint Venture(s) and BVL internal development support for Manufacturing, Process Validation, Quality Assurance/Control and Engineering.
· Be responsible for projects that are of greater complexity and longer duration than assigned to less experienced staff members.
· Provide technical leadership for more junior scientists
· Be responsible for analytical test methods development, qualification, validation and transfer.
· Be involved in the characterization of drug substance and drug product impurity.
· Provide analytical support for formulation development.
· Be involved in the development and/or qualification of reference standards (including secondary reference standards) and raw material testing and qualification.
· Be involved in the development batch (whether in Product Development or Production) In-Process testing, Final Product, Raw Material and various Stability tests.
· Have significant role in the technology transfer process to Quality Control.
· Perform various studies in response to FDA letters of exception.
· Be responsible for enlisting and coordinating the efforts of various customers and/or departments from the initial literature research, through the finished product release and stability testing.
· Generate documents and reports in support of work (product information package, validation reports, stability data, etc.)
· Develop and validate cleaning methods.
· Review Master Batch Records.
· Serve as an analytical methods development, and/or product development expert in the laboratory.
· Investigate, evaluate and recommend instruments.
· Perform or arrange necessary training for Chemist and Scientist employees as determined by the management staff.
· Take ownership of special projects as assigned.
· Perform miscellaneous duties as assigned.
· Approve analytical methods when requested.
- · Requires a minimum four year Bachelor’s degree in Analytical Chemistry or a closely related science. A Ph.D. in Analytical Chemistry is highly preferred.
· Must demonstrate consistently high proficiency with HPLC, GC, IR, UV, KF and TLC as well as wet chemistry techniques.
· A minimum of 8 years of extensive pharmaceutical product development experience and an advanced degree in a pharmaceutically related science OR a minimum of 15 years of extensive pharmaceutical product development experience is required. Experience must include analytical methods development, research, problem-solving and experimental design, as well as computer literacy and documentation/report writing.
· Expertise in parenteral development is desirable. Expertise is preferably supported by demonstrated peer reviewed publications, patents, or abstracts.
To Apply for this position, please CLICK HERE
Additional Salary Information: Commensurate - Commensurate