Sr. Drug Product Operations Sample Coordinator

Responsibilities

• Receives incoming samples for laboratory testing and initiates chain-of-custody tracking in electronic system.
• Samples involve raw materials, bulk drug substances, components, formulation prototypes, in-process and finished drug products.
• Manages the labelling, storage, chain-of-custody, and disposition of samples (including controlled substances).
• Uses computer software programs to generate projects for laboratory testing.
• Laboratory experience with analytical testing is preferred.
• Communicates and collaborates with the Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records, analytical methods and specifications are released.
• Captures and coordinates the raw material and components sampling for testing, and maintains responsibility for the transport of samples from manufacturing to labs.
• Sets the committed dates and monitors the status of laboratory testing to ensure COA is issued on time.
• Conducts weekly meetings and communicates routinely with all key stakeholders.
• Handles the logistics for outsourcing work, from requesting quotes and PO to receiving results for reporting.
• Performs documentation accurately and completely.
• Complies with safety policies and procedures.
• Works efficiently in a team setting, with ability to multi-task in a high-pace environment.
• Ensures timely completion and compliance with cGMP, EHS, DEA, and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field preferred and 2+ years of related experience required.
• High school diploma or GED and 6+ years of related experience required.
• Pharmaceutical, CDMO, or cGMP experience strongly preferred.