Bioanalytical Specialist

About Pharma Medica Research Inc.

We are a full-service contract research organization specializing in early-phase clinical trials for healthy volunteers, special populations, and patients.

Our team is seeking a Bioanalytical Specialist to join our bioanalytical laboratory.

The Bioanalytical Specialist will perform various tasks to support bioanalytical drug testing and analysis. This role reports directly to the Team Leader/Bioanalytical Lab or designee.

Main Responsibilities:

• Equipment Maintenance and Operation: Ensure calibration and proper functioning of all key laboratory equipment, including HPLC, LC/MS, LC-MS/MS, balances, pH meters, pipettes, freezers, water systems, and fume hoods.
• Study Preparation: Order necessary supplies for assigned clinical or pre-clinical studies, prepare pools and randomization charts, and ensure that all involved technicians are trained on analytical methods.
• Technician Supervision: Oversee technicians during sample preparation, reviewing and approving documentation as required.
• Standard Operating Procedures (SOPs): Develop, update, and maintain SOPs according to regulatory requirements.
• Method Validation: Conduct method validations and write comprehensive method reports.
• Collaboration and Communication: Liaise with the Principal Bioanalytical Investigator and Quality Control to ensure timely completion of analytical assays.
• Record Keeping and Compliance: Maintain accurate records and logs, signed and witnessed as necessary, adhering to laboratory GLP/SOPs and regulatory requirements.
• Laboratory Activities: Perform laboratory activities in compliance with PMRI's SOPs and Good Laboratory Practices (GLPs).
• Suggestions for Improvement: Provide recommendations on how to enhance laboratory operations, SOP content, and GLP compliance.
• Method Development and Validation: Assist in the development and validation of bioanalytical methods in accordance with FDA, TPP, and international regulatory requirements.

To be successful in this role, you should possess:

• A B.Sc. or Community College diploma in Chemical Technology or a related science.
• 1-2 years of experience in bioanalytical technician roles.
• Strong communication skills, including proficiency in English verbal and written communication.
• Excellent interpersonal skills.
• Ability to work independently and collaboratively as part of a team.

$60,000 - $80,000 per year, depending on experience.