Medefil announces launch of 10% Calcium Chloride Injection, USP – 10 mL Single-dose Pre-filled Syringe

Analytical Scientist

  • Reference ID: Med001
  • Type: Permanent

We are currently seeking experienced analytical scientist for our drug development team based in a Chicago Suburb. The candidate should have direct experience with analytical method development, validation, and analysis for parenteral dosage forms.

Responsibilities

  • Lead analytical development of parenteral formulations in a product development environment.
  • Act as a Subject Matter Expert for chromatograph techniques such as HPLC, GC, TLC, IC, LC-MS, and GC-MS.
  • Lead different wet chemistry testing.
  • Responsible for leading all analytical aspects of a project while working with other functional areas to advance projects through the pipeline.
  • Lead API and finished product related method development, optimization, validation, and release and stability testing.
  • Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
  • Responsible for all aspects of Analytical Development and Validation including transfer to Quality Control or other testing laboratory.
  • Evaluate thoroughly DMF for different APIs for completion of analytical methods and lead discussions with API manufacturers to evaluate analytical method package.
  • Support corporate quality and continuous improvement process.
  • Write protocols, methods, standard operation procedures, and submission documents independently. Design experimental studies and write reports with minimal supervision.
  • Supervisor CRO work to ensure corporate quality is maintained and activities are performed on timely manner.
  • Maintain through knowledge of ICH conditions, USP method development, validation, and verification requirements.
  • Accurately records experimental procedures, test results, and observations to meet GMP requirements.
  • Maintain experimental records, procedures to meet cGMP requirements.
  • Participate in the review process for appropriate department SOPs, study protocols, and reports.
  • Participate in the training of incoming laboratory staff.
  • Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification.
  • Author various sections in Chemistry, Manufacturing and Control (CMC) document for Regulatory submission.
  • Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
  • Provide crucial support to other team members in the conduct of their studies.

Requirements

  • Ph.D. and MS in Chemistry or other related field with 3+ years’ experience.
  • Ability in the area of characterization of peptides is desirable.
  • Working knowledge of cGMPs, cGLPs

Skills (Reading, Writing, Verbal Communication, Computer, etc.):

  • Must be able to work independently and have good time management skills
  • Proficient in writing.
  • Excellent organizational, communication, teamwork, and interpersonal skills
  • Strong leadership and mentoring skills

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