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Sample Management and Formulation Specialist

2 months ago


Irvine, California, United States Pharmaron Full time
Job Overview

Position: Formulations and Sample Management Associate


Are you prepared to take on an exciting role with a dedicated team focused on impactful contributions? Pharmaron is eager to welcome a new Formulations and Sample Management Associate.

This position is based onsite.


Role Summary:

We are in search of a skilled Formulation and Sample Management Associate who possesses both hands-on experience and technical knowledge for our preclinical service laboratory. In this vibrant role, you will be integral to our formulation, filling, and finishing processes, contributing significantly to the preparation of various test articles for both non-GLP and GLP preclinical studies. Your meticulous attention to detail will be crucial as you carefully document each phase of our manufacturing operations, ensuring adherence to the highest standards.


Key Responsibilities:

  • Receive, document, and upload essential information for incoming test articles, substances, and reagents into the database, maintaining accountability records.
  • Order excipients and supplies for formulation of test and control articles, ensuring proper storage and sampling according to study protocols.
  • Ensure correct storage and labeling of test articles, including cell therapy products and specimen samples, while keeping accurate records.
  • Prepare and document dosage solutions and suspensions for test articles, adhering to instructions, SOPs, and study protocols.
  • Maintain and characterize mammalian cell lines for use in in-vivo studies as control or test articles.
  • Support cell-gene therapy projects by producing injectable forms of products for in-vivo testing.
  • Manage the shipment of formulation samples and specimens in compliance with IATA regulations.
  • Facilitate the return of test articles from completed studies to sponsors as required.
  • Respond to Quality Assurance audits concerning preparation procedures and calculations.
  • Maintain inventory of reagents, test articles, vehicles, and samples.
  • Operate and calibrate general laboratory equipment.
  • Dispose of hazardous chemical reagents in accordance with local regulations.

Qualifications:

Skills and Experience:

  • Associate's or Bachelor's degree in a relevant field.
  • 2-3 years of pertinent laboratory experience in biology or chemistry, or an equivalent combination of education and experience.
  • Proficiency in calculating molarities, weight-to-volume, and weight-to-weight ratios for complex formulations.
  • Ability to plan and execute fill-and-finish tasks based on demand and product specifications.
  • Strong communication skills, attention to detail, and a solid work ethic.
  • Self-motivated with the ability to adapt in a dynamic team environment.

Why Choose Pharmaron?

Pharmaron is a leading entity in the life sciences sector, providing top-tier R&D services to partners worldwide. With a workforce exceeding 20,000 professionals and operations across multiple countries, Pharmaron is dedicated to delivering innovative R&D solutions that propel advancements in healthcare.

Collaborative Environment: You will thrive in our inclusive and collaborative atmosphere, where teamwork and innovation are paramount. Your contributions are valued, and your input has a meaningful impact. Our core cultural values emphasize the importance of employees and client focus.

Comprehensive Benefits: We are committed to your well-being, offering a robust benefits package that includes medical, dental, and vision insurance with significant employer contributions. Our 401k plan with employer matching simplifies your future planning. Additionally, you will have access to an Employee Assistance Program to support your work-life balance.

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron champions diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed.