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

Manufacturing Group Leader possessing comprehensive experience across all phases of pharmaceutical production, building, and improving highly efficient, cross-functional team.

Technical expertise includes Column Chromatography, tangential flow filtration, cGMP compliance, SOP development, operational / workflow efficiency, process validation and technology transfers.

Responsibilities

The area supervisor is responsible for the safe, compliant, and Right First Time, hands-on, and supervision of purification processing to produce clinical and commercial material that is compliant with cGMPs and meets strategic objectives.

Processing experience includes but not limited to : Chromatography, writing / using unicorn methods, Tangential Flow Filtration, Aseptic processing, bulk drug substance and drug product operations.

• Lead a team of 4-6 direct reports. Responsible for assigning and distributing daily work and coordinating emergency situations.
• Lead investigations as related to the manufacturing process. Author Change controls, deviations, and CAPAs as required.

Partner with Quality to address issues effectively and compliantly.

• Author, Review, and Approve cGMP documentation (batch records, protocols, and SOPs). Periodic review of cGMP documentation to ensure all are accurate and updated as required.
• This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
• Serves as the Subject Matter Expert for the production area, both for manufacturing personnel and in communication with other functional groups.
• Identify and implement continuous improvement opportunities.
• Exhibit and champion a safety-first culture. Lead, initiate, and contribute to safety initiatives, investigations, and CAPAs.
• Support technology transfer and / or process development through active participation in ensuring that new processes fit and execute consistently in the cGMP space.
• Manages complex assignments, where independent action and a high degree of initiative are required to resolve problems and make recommendations.
• Responsible for driving facility upkeep and ensuring the facility is always audit-ready.
• Lead and mentor staff. Develop staff into Subject Matter Experts in applicable process areas. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.
• 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 the ability to perform complex data management.

• May be required to serve as the area Manager, in the absence of the Area Manager

Qualifications

• degree in Chemical Engineering, Biology, or similar relevant field with at least 6 years of direct GMP manufacturing experience in a biotechnology manufacturing facility or Pilot Plant OR a High School Diploma with 10 years of experience in protein purification in Biotech / Pharmaceutical industry.
• At least 5 years Protein purification experience under GMP conditions in Pharmaceutical / Biotech industry.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. Demonstrated leadership skills.
• Project management skillset with experience in strategic / tactical planning, team building, and meeting budgets.
• Thorough knowledge of FDA regulations and GMP systems. Understands the implications of procedures and deviations within his / her own discipline.
• Experience with cell and or gene therapy manufacturing as well as managing direct reports a plus.
• 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.
• Must be able to lift up to 50 lbs.
• Seldom ascend / descend a portable staircase and works at heights up to 6 feet above floor level

Last updated : 2024-04-23