Clinical Manufacturing Associate I

Overview

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases.

Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline.

We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients.

This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator.

In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary

As a Clinical Manufacturing Associate, you will be part of a team responsible for the start-up of a cleanroom facility and the cGMP manufacture of viral vector therapies for use in clinical trials.

Additional responsibilities include set-up, operation, and cleaning of equipment, equipment, and process monitoring and troubleshooting, receiving materials and supplies from the warehouse, maintaining supply inventories, creating technical documents, and maintaining cleanrooms and equipment in an inspection-ready state.

The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to contribute individually and collectively in a dynamic, fast-paced environment.

Responsibilities

• Perform hands-on process operations as directed to manufacture viral vector therapies;
• Work on projects and assignments that require independent action and initiative, and direct communication and collaboration with diverse groups;
• Request, receive, process and store process materials and supplies through direct communication and coordination with Materials Management / Warehouse personnel;
• Maintain process equipment and manufacturing areas in a safe and compliant readiness state; observes and follows all safety, regulatory, legal and compliance requirements;
• Author Standard Operating Procedures and other technical documents with minimal supervision;
• Follow all Standard Operating Procedures and completes all batch documentation including Batch Records, Forms, logbooks, Sample Requests and Test Results;
• Troubleshoot problems; proactively assess options and impact and communicate to appropriate decision makers

Qualifications

• in Life Science, Biotechnology, ChemE, or similar relevant field with 0 to 2 years’ experience in clinical manufacturing or High School Diploma with 2+ years’ experience;
• Understanding of basic mammalian / microbial cell culture techniques and principles, filtration principles, purification / chromatography principles and good aseptic techniques;
• Execute production of clinical supplies based on established procedures and protocols and implements improvements with minimal supervision;
• May be required to work off-shift hours : early mornings, late evenings / nights, and weekends if necessary;
• Anticipate / recognize potential problems with equipment, supplies, documents, or processes and takes action to resolve or prevent problems;
• Collaborate with other departments, teams, and stakeholders and through negotiation and influence gain their consensus and support to resolve issues;
• Recognize when to communicate or escalate issues to management;
• Ability to accurately complete and compile official documentation per Rocket Good Documentation Practices (GDP) requirements;
• Follow verbal and written instructions when completing assignments;
• Complete tasks with attention to detail and right-first-time mind set;
• Perform all assignments in a manner aligned with Rocket’s values and behaviors

Physical Requirements

• Constantly works in a cleanroom environment with moving mechanical parts and variable noise levels
• Constantly works with biohazard materials and chemical solutions including bleach and Spor-Klenz
• Constantly wears cleanroom garments (for example, composite-toed safety shoes, safety glasses, coverall, hairnet, beard cover, shoe covers, nitrile gloves, face mask)
• Occasionally wears cleanroom PPE (for example, face shield, chemical resistant gloves)
• Must be able to remain in a stationary position for 50% of the time
• Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens
• Constantly communicates verbally with people to exchange information, and give and receive instructions
• Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials
• Frequently positions portable equipment weighing up to 22 lbs. and occasionally positions portable equipment weighing up to 50 lbs.
• Frequently moves material containers weighing up to 50 lbs.
• Seldom ascend / descend a portable staircase and works at heights up to 6 feet above floor level
30+ days ago