Senior Clinical Manufacturing Associate

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

 

Rocket Pharma is a fully integrated, commercial-stage biotechnology company advancing genetic medicines for rare and devastating diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking genetic medicine cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

As a Senior Manufacturing Associate, you will be part of a team responsible for 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.

 

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 following safe, compliant, and Right First-Time manufacturing operations procedures to produce clinical/commercial material that is compliant with cGMPs and meets site objectives
• Perform hands-on process operations as directed, including but are not limited to, ordering materials from warehouse, material preparation and steam sterilization, cleaning in materials, mammalian cell culture, production bioreactor operation, chromatography purification, TFF, and drug substance filling.
• Anticipate/recognize potential problems with equipment, supplies, documents, or processes and takes action to resolve or prevent problems
• Demonstrate high performance in clean rooms, including batch record execution, aseptic techniques in a BSC, gowning and overall clean room behaviors.
• Lead the safety-first culture in Manufacturing, report all incidents and escalate safety issues.
• Accurately complete and compile official documentation per Good Documentation Practices (GDP) requirements
• Author and review SOPs and batch records
• Train and mentor more junior staff and assist in the development of staff process knowledge
• Support or lead investigations related to manufacturing process operations
• Author deviations, impact assessments, and CAPAs as required
• Serve as Subject Matter Expert (SME) for the production area, both for manufacturing personnel and in communication with other functional groups
• Identify, lead, and implement continuous improvement projects
• Troubleshoot problems, proactively assess options and impact, and communicate to appropriate decision makers

 

 

Qualifications

• Bachelors in Life Science, Biotechnology, Chemical Engineering or similar relevant field with 5 years of experience in the pharmaceutical, biotech, or cell and gene therapy industry, or a High School Diploma with 9 years of experience
• Proficient in bioprocessing operations including cell culture techniques and principles, bioreactor operations, depth filtration, tangential flow filtration, chromatography, or single-use techniques and principles
• 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
• Understanding of compliance and regulatory guidance
• Strong collaborative spirit with other departments, teams, and stakeholders and through negotiation and influence gain their consensus and support to resolve issues
• Ability to perform work according to project timelines and business requirements

Physical Requirements:

• Ability to work outside of regular business hours per manufacturing schedule needs
• Ability to wear cleanroom PPE (for example, face shield, chemical resistant gloves)
• Ability to stand upright for extended periods of time during operations
• 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
• Able to position portable equipment weighing up to 22 lbs. and occasionally position portable equipment weighing up to 50 lbs
• Frequently work in a cleanroom environment with moving mechanical parts and variable noise levels
• Frequently work with hazardous materials and chemical solutions including bleach and Spor-Klenz®
• Frequently wear cleanroom garments (for example, composite-toed safety shoes, safety glasses, coverall, hairnet, beard cover, shoe covers, nitrile gloves, face mask)

Compensation

The expected salary range for this position is $85,000 to $113,000. 

 

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

 

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

 

In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.