Quality Control Lab Manager

Overview:

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

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy 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:

This Quality Control (QC) Lab Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset.

The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy.

Responsibilities:

• Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents
• Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays
• Supporting Management by performing peer reviews of testing data
• Supporting Method Performance tracking and trending through data entry, verification, and record archival
• Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts
• Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc.
• Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration
• Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management
• Support revision of SOPs and forms to improve workflows in QC
• Overseeing Housekeeping activities of lab areas
• Verifying Logbooks are reviewed on time
• Tracking Lab Notebooks lifecycle
• Working with EHS to improve Safety Culture in QC

Qualifications:

• M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry.
• Ability to be onsite 5 days per week
• Deep understanding and experience with working in a GMP environment
• Experience with ddPCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays
• Ability to work independently and make decisions
• Leadership experience and project management skills to support a multi-project environment in small biotech.

Physical Requirements:

• Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials
• Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz
• Constantly wears proper PPE including lab coat, safety glasses and 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

Compensation:

The expected salary range for this position is $122,000 to $144,000.

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.