Lab Systems Senior Manager
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of eighteen programs initially focused on genetic diseases with a fast, direct path to treating patients or with a high unmet need because they cannot be treated using other gene-editing approaches. Over time, the Company intends to maximize Prime Editing’s therapeutic potential and advance potentially curative therapeutic options to patients for a broad spectrum of diseases. For more information, please visit www.primemedicine.com.
The Lab Systems Senior Manager will play a strategic role to partner with the R&D and Technical Operations stakeholders (both lab scientists & QA functions) to understand their present and future needs for digital lab systems.
Additionally, you will lead the Lab Systems team to interface with scientists and external vendors to execute day-to-day tasks such as troubleshooting and implementing solutions. Your ability to leverage innovative tools to empower R&D/TechOps teams while also being at the forefront of hands-on execution makes you an invaluable asset. Your leadership will be pivotal in optimizing scientific requirements, Prime Medicines (PM) IT protocols, and vendor constraints to craft solutions that exceed scientific expectations.
- Work as an IT business/systems analyst to support R&D/TechOps stakeholders in lab centric aspects of Prime’s Digital Lab Systems.
- Act as a Project Manager to support the implementation of new systems and processes
- Directly manage a small team to execute day-to-day tasks and larger project implementations
- Work as a technical lead to troubleshoot, configure, and implement non-GxP and GxP systems
- Responsible for following & enhancing good documentation practices and change management processes as outlined in our policies and procedures (e.g., SOP’s, SDLC)
- Responsible for collaborating with the Informatics team to support LIMS, ELN, SDMS, CMMS, CDS, and other lab systems.
- Responsible for collaborating with scientists to deploy lab systems for common workflows (MassSpec, LCMS, HPLC, Flow Cytometry, NGS & Imagery).
- Responsible for collaborating with the IT Operations team to ensure seamless instrument operations and proactively addressing scientists' issues via ticketing systems, in-person meetings, and
- Oversee Managed Services Providers and vendors that support our applications
- Work collaboratively with the CSV/Quality team to manage validation deliverables
- Coordinate changes in accordance with established change control procedures
- Communicate issues, technical failures, and projects status updates to direct manager
- Responsible for communication strategy in respect to application management and support. (e.g., regular meetings with stakeholders, meeting minutes, weekly highlights)
- Responsible for following industry regulations, policies, and procedures (21 CFR Part 11, Data Integrity, GAMP 5, CSV, CSA) when implementing and supporting GxP systems
- 5+ years of managerial experience, combined with hands-on engagement in IT operations within a biotech environment.
- 10+ years of comprehensive IT experience, with a preference for direct troubleshooting and problem-solving roles.
- Profound understanding of Biotech or Biopharma in relation to scientific equipment vendors, software applications, and systems.
- Hands-on experience with IT setups of key lab instruments such as GE, Mermade, Hamilton, Waters, Cytiva/Akta, and Agilent.
- Solid Experience with associated software suites such as Empower, Chromeleon, Halo, FlowJo, etc..
- Exceptional customer service approach, coupled with a knack for hands-on problem resolution and strategic foresight.
- Resilient and adaptive mindset, ready to dive into evolving needs and excel in ambiguous scenarios.
- Expertise in troubleshooting hardware, software, and networking issues (TCP-IP, VLANS, Firewalls) from both a managerial and hands-on perspective.
- Demonstrated ability to effectively communicate with teams, senior management, and clients, coupled with hands-on mentoring skills
This is a great opportunity for someone who is eager to contribute and collaborate with stakeholders that value bringing cutting-edge technologies and solutions to end users and ultimately our patients. You will have an important role in implementing, validating, and supporting a variety of lab systems.
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.