Opportunity to work in the drug substance and drug product development industry.
Job Detail
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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- Great opportunity in beautiful Florida and great benefits!