Analytical Scientist II

Medefil, Inc.

Analytical Scientist II

Job Description

Location: Glendale Heights, IL

Department: Drug Development

Level/FLSA: Exempt

Position Summary

• Lead analytical development of parenteral formulations in a product development environment.
• Analyze API, excipients, formulation development finished product samples using appropriate instrumentation (GC, GC-MS,
• HPLC, HPLC-MS, dissolution, UV, IR, KF, pH etc.) and wet chemistry techniques.
• 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.
• Must possess knowledge regarding various tests and wet chemistry that pertain to pharmaceutical analysis (heavy metals,
• ROI, Surface Tension, Density, Viscosity, TLC, etc.).
• 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.
• Work on API, excipients, and finished product related method development, optimization, validation, and release and stability testing with minimum supervision.
• Assist in writing protocols, methods, standard operation procedures, and submission documents.
• Maintain experimental records, procedures to meet cGMP requirements.
• Perform other duties as assigned.

Qualifications

• Ph.D. in Chemistry with 2 years’ experience or other related field or MS in Chemistry or other related field with 4 years’
• experience or BS in Chemistry or other related field with 7 years’ experience
• Good scientific knowledge and experience in the operation of various analytical instruments.
• Analytical instrument qualification and validation experience preferred.
• Standard test method and standard operating procedure and specifications technical writing experienced preferred
• Minimum 4 years of experience in pharmaceutical industry after BS.
• Good scientific knowledge and experience in the operation of various analytical instruments.
• Analytical instrument qualification and validation experience preferred.
• Standard test method and standard operating procedure and specifications technical writing experienced preferred.
• Familiarity with regulatory guidance documents (ICH, USP, CFR, general guidance) is preferred.
• Working experience with HPLC, GC, FTIR, Karl Fischer Titrator, AA, UV-Vis and polarimeter
• Working experience with GC-MS, LC-MS, ICPMS and other analytical instruments is preferred.

• Strong scientific background and understanding in basic wet chemical analysis.
• Ability to independently follow and comply with analytical test methods, Standard Operating Procedures (SOP), specifications and have good time management skills.
• Proficient in using Microsoft Excel and Word.
• Excellent organizational, communication, teamwork and interpersonal skills.
• Excellent attention to detail and writing skills

Medefil, Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran’s or disability status.”

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Master's (Preferred)

Experience:

• Laboratory Experience: 3 years (Preferred)

Work Location: One location