Scientist

in Pharma
  • United States, Remote View on Map
  • Salary: $130.00 - $135.00
Contract

Job Detail

  • Experience Level Senior
  • Degree Type Bachelor of Science (BS)
  • Employment Part Time
  • Working Type Remote
  • Job Reference 0000007977
  • Salary Type Hourly
  • Industry Biotech
  • Selling Points

    Opportunity to work in the drug substance and drug product development industry.

Job Description

Responsibilities:

  • Lead analytical development for both drug substance and drug product development for solid oral dosage form
  • Collaborate with other functional areas in CMC project team to deliver project milestones on time and within budget
  • Work with CDMOs and manage activities of method development, method transfer, method validation and QC testing (release and stability) to ensure timely delivery of high-quality work
  • Author relevant sections in regulatory filings and address agency questions
  • Support manufacturing and quality deviation and OOS/OOT/OOE investigations
  • Follow all safety and compliance regulations and company policies

Qualifications:

  • Advanced degree in Analytical Chemistry or a related discipline. Minimum 12 years of industry experience.
  • Must have hands-on experience in analytical method development, qualification, and support validation for small molecules drug substances and drug products
  • Must have extensive knowledge and hands-on experience with analytical techniques including HPLC, LCMS, GC, GCMS, UV/Vis, and Dissolution.
  • Experience of impurity identification and qualification in both Drug Substance and Drug Product is a plus.
  • Knowledgeable in ICP-MS/IPC-OES, DSC, DVS and XRPD techniques are a plus
  • Working knowledge of quality and regulatory requirements of small molecule products including cGMP/GLP, FDA, USP, Ph. Eur, and ICH guidelines
  • Experience in working with CDMO to lead method development, method transfer, method qualification/validation to support GMP manufacturing of drug substance and solid oral dosage form drug product.
  • Excellent problem-solving skills and verbal and written communication skills.
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