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Clinical Manufacturing Associate II

4 months ago

Cranbury, United States Rocket Pharmaceuticals Full time

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 Manufacturing Associate II, 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 and commercial launch. Additional responsibilities include set-up, operation, and cleaning of equipment, equipment, and process monitoring and troubleshooting, ordering and receiving materials, authoring technical documents, training and mentoring junior staff, leading quality, and process improvement projects, and collaborating with functions supporting cGMP manufacture.

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

· Responsible for the safe, compliant, and Right First-Time manufacturing operations within downstream to produce clinical/commercial material that is compliant with cGMPs and meets site objectives. Manufacturing processes include but are not limited to ordering materials from warehouse, cleaning in materials, chromatography, TFF, and drug substance filling.

· Demonstrate high performance in clean room including batch record execution, aseptic techniques in a BSC, gowning and overall clean room behaviors.

· Lead in improving safety culture in Manufacturing. Reporting all incidents and escalating and safety issues.

· Leads equipment FAT, SAT, and facility start-up as needed.

· Authors, revises, and approves cGMP documentation (batch records, protocols, and SOPs);

· Perform periodic review of cGMP documentation to ensure accuracy. Accurately complete and compile official documentation per Rocket Good Documentation Practices (GDP) requirements.

· Train and mentor staff.

· Assist in the development of staff process knowledge.

· Support or lead investigations related to the manufacturing process. Author deviations, non-conformances, and CAPAs as required.

· Serves as the Subject Matter Expert for the production area, both for manufacturing personnel and in communication with other functional groups.

· Prepare oral or written presentations of results with interpretation. Prepare and communicate conclusions and recommendations for the next steps, to team members and upper management. Demonstrate ability to perform complex data management.

· Identify, lead, and implement continuous improvement projects.

· Support the internal or external tech transfer of new products and processes.

Qualifications

Job Requirements:

· ./. in Life Science, Biotechnology, ChemE, or a similar relevant field with 3+ years of experience in the pharmaceutical, biotech, or cell and gene therapy industry, or a High School Diploma with 6+ years of experience.

· Subject matter expert in clinical manufacturing including cell culture techniques and principles, bioreactor operations, depth filtration, OR tangential flow filtration, chromatography, and single-use techniques and principles.

· May be required to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary.

· Excellent oral and written communication skills. Strong technical writing ability required.

· Ability to motivate and mentor peers and staff, foster a culture of continuous improvement and operational excellence.

· Address and improve compliance and regulatory gaps/ issues.

· 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.

· Performance of 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.

· Seldom ascend/descend a portable staircase and works at heights up to 6 feet above floor level.