Clinical Manufacturing Associate

Job Title : Clinical Manufacturing Associate

Location : Warren, NJ (Onsite)

Work Schedule : Friday - Monday, 10am-8 : 30pm or 8am-6 : 30pm

Assignment Duration : 6 months with the possibility of extension

Are you passionate about cutting-edge clinical manufacturing? Do you thrive in a dynamic, team-oriented environment? If so, we invite you to apply for our Clinical Manufacturing Associate position!

About the Role :

As a Clinical Manufacturing Associate, you will play a crucial role in the production of blood component lots, ensuring adherence to the highest standards of quality and safety.

This is an exciting opportunity to contribute to life-changing advancements in the medical field while working with a dedicated team of professionals.

Responsibilities :

• Overseeing the production of blood component lots through a series of processes including cell culture, harvest, and cryopreservation.
• Demonstrating mastery in aseptic techniques, ensuring the highest standards of cleanliness and safety are maintained.
• Undergoing comprehensive training and achieving qualification in all aspects of the assigned processes, ensuring a thorough understanding and ability to execute tasks efficiently.
• Accurately weighing and measuring in-process materials to ensure the correct quantities are added or removed, thereby maintaining the integrity of the production process.
• Strictly adhering to the production schedule to ensure on-time, internal production logistics, contributing to the overall efficiency of our client's operations.
• Diligently recording production data and information in a clear, concise format, adhering to proper Good Documentation Practices (GDPs).

Skills Required :

• A Bachelor’s degree in an applicable science or engineering field, coupled with a minimum of 2 years of relevant experience.
• A fundamental understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Prior experience within a cGMP / FDA regulated industry, demonstrating a strong understanding of industry standards and regulations.
• Basic mathematical skills, enabling accurate calculations and measurements.
• Proficiency in technical writing, ensuring clear and effective communication of complex information.
• Proficiency in MS Office applications, demonstrating a strong ability to utilize digital tools in the execution of tasks.
• An advanced understanding of cell culture, demonstrating a deep knowledge and expertise in this area.

About SSi People :

With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.

Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly.

More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.