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Research and Development Scientist II

Department: Chemistry
Location: West Columbia, SC

RESEARCH AND DEVELOPMENT SCIENTIST II

Position Summary:

  • Development and Validation of New Products, including, but not limited to, analytical test method validation/transfer/verification, deformulation, new formulation, procedures, investigations, manufacturing process, and other non-specified projects or initiatives.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

  • Capable of working in a GMP environment and responsible for generating GMP data.
  • Capable of working with different analytical techniques like HPLC, UPLC, LC/MS, GC, GC/MS, Osmometer, Automatic Titrator, pH Meter, etc.
  • Capable of understanding and implementing the FDA/ICH Guidance attending the project needs: method validation, specifications, impurities, genotoxic impurities, residual solvent, leachable, product development, etc.
  • Responsible for conducting new product development with respect to formulation, development of analytical techniques, small scale laboratory formulation, and early to mid phase process development.
  • Responsible   for   conducting  the  development   and  validation   of  analytical   methods  for pharmaceutical ingredients and dosage forms, including establishment of specifications.
  • Responsible for drafting and/or reviewing protocols reports, and/or laboratory notebooks.
  • Responsible for evaluating new raw materials and components for quality and safety prior to implementation into exhibit batches and GMP production.
  • Responsible  for  drafting  SOPs  related to  Quality  Control  and  Research  and  Development functions, equipment, documentation, and/or processes.
  • Draft initial release specifications for materials, products, and components intended for use in a GMP environment.
  • Participates in the development and implementation of associated programs (e.g. cleaning, validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.)
  • Contributes to other non-specified  projects and initiatives of the Research and Development Group as necessary.
  • Contributes to the Research and Development Stability Program as necessary.



Knowledge, Skills & Abilities:

  • Regionally accredited Bachelor Degree required, Master or above preferred:
    • Ph.D. Analytical Chemistry
    • MAIMS Analytical Chemistry
      • At  least  2  years  of  experience  with  analytical  method  development  and validation and product development projects.
      • 2-4 years of experience  working directly  with  HPLC, UPLC, LC/MS, GC, and/or GC/MS.
    • BA/BS in Chemistry
      • At  least  4  years  of  experience  with  analytical  method  development   and validation and product development projects.
      • 4-6 years  of experience  working directly with  HPLC, UPLC, LC/MS, GC, and/or GC/MS.
  • Highly skilled in conducting analysis by HPLC, GC, FT-IR, UV/Vis spectroscopy as well as wet chemistry techniques,  needing little or  no guidance.
  • Must possess excellent analytical skills and problem solving ability, strong attention to detail, sound understanding of cGMP regulations pertaining to laboratory controls and a thorough knowledge of USP and compendia I standards.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • The ability to create new products and processes that add value to the Business, by generating new ideas and apply creative and analytical approaches.
  • Ability to effectively communicate with laboratory staff and management as well as other departments and external customers as directed by management.
  • Possesses the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management.
  • Must strive for continuous improvement in all work activities.
  • The ability to effectively use a multitude of resources and to be accurate and current with data and information.
  • Position requires  bending, typing, climbing, lifting, reaching, vision  (20/20),  standing (SO%), sitting (30%), walking (20%), gripping and hearing.
  • Position encounters the following environmental factors: hazardous materials including Acids, Bases, Oxidizers, Corrosives, Flammables and other non-specified hazardous materials that are project specific.
  • Incumbents  are  required  to  wear  safety  glasses,  laboratory  coat  and  other  non-specified protective equipment as necessary.
  • Additional Requirements:
  • Salary range: Based on experience

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