We are seeking a highly motivated, creative and meticulous manager to contribute to the analytical development and quality control activities in support of drug substance and drug product development across all stages of development. In this role, you will not only work with stakeholders but also our CMO’s on analytical activities in support of drug substance (DS) and Drug product (DP) manufacture and release.
- You will be responsible for coordinating & overseeing our analytical method development and phase- appropriate method validation/transfer activities for full characterization of a small molecule NCE.
- Collaborate and manage analytical development and validation activities to enable characterization, release and stability testing at our CMO’s / CRO’s of Relay clinical candidates.
- You will have opportunity to introduce modern analytical technologies as part of analytical method development processes.
- Perform review of method transfer/validation protocols, data sets and reports.
- It will be your responsibility to provide oversight of the QC testing at analytical testing labs, DS and DP manufacturing sites.
- You will review QC raw data from third parties to support batch release and stability.
- You will perform review of data and summarize analytical data (release & stability) from CMO/CROs, data trending, alert team of any issues in timely manner and assist in providing resolution.
- Oversee and support data trending on stability to justify shelf life and expiry dating of DS and DP
- Support reference standard program including maintaining recertifications of reference standards
- Review & approvals of method qualification protocols and reports at external laboratories as appropriate
- Are you a talented multi-tasker? In this role, you will handle multiple projects and adjust to shifting priorities
- Do you believe working effectively across functions is the key to success? You will work with CMC, Quality assurance & Regulatory Affairs to develop appropriate regulatory and development strategy.
- You have earned your BS or MS in Analytical Chemistry or Biotechnology or related disciplines with at least 5 to 8 years of industrial experience
- Expertise in analytical development, validation, stability data trending, troubleshooting and quality control
- It will be critical that you have excellent analytical knowledge and technical expertise in small molecule analytical methods for drug substance and oral solid dosage forms
- Detailed familiarity with regulatory and analytical guidelines, including strong knowledge of cGMPs, ICH, FDA, USP and other relevant global regulatory requirements.
- Working knowledge and expertise in analytical instrumentation including HPLC, dissolution, GC, KF titration, XRPD, ICP-MS, UV, solid-state characterization techniques.
- Previous experience with filing or working on IND and/or NDA filings is a plus.
- You are an open and articulate communicator who can collaborate effectively with contract laboratories and manufacturing facilities as well as internal staff.