Senior Analytical Scientist Pharmaceutical Product and Process Development

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Senior Analytical Scientist Pharmaceutical Product and Process Development

Senior Analytical Scientist - Pharmaceutical Product and Process Development
chemistryjobs.acs.org/jobdetail.cfm

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.

REQUIREMENTS:

    · 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
 

NOTES:

Additional Salary Information: Commensurate - Commensurate