Sr. Manager, Reagent Manufacturing

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Summary:

We are looking for a highly motivated and experienced Reagent Team Manager to lead our reagent manufacturing team. You'll oversee the production and quality control of critical reagents, ensuring all processes adhere to strict quality standards and documentation protocols. This is a fantastic opportunity for a proactive leader who thrives in a fast-paced, hands-on environment and is passionate about driving continuous improvement in a cutting-edge genomics setting.

Onsite: 5 days / week

Duties & Responsibilities:

• Team Leadership: Manage and schedule daily and weekly manufacturing activities, providing technical guidance and support to your team of Manufacturing Associates.
• Quality & Compliance: Ensure all manufacturing and release testing of reagents are performed according to Standard Operating Procedures (SOPs), Good Documentation Practices (GDPs), and ISO 13485 quality standards. You will also review weekly and monthly lab and equipment maintenance logs to ensure quality control.
• Process Improvement: Actively identify and resolve production issues by collaborating with Process Development and Quality Assurance. You'll also drive continuous improvement projects to enhance efficiency, quality, and workflow.
• Documentation & Training: Draft, maintain, and update Reagent Manufacturing forms and SOPs. You will also be responsible for training new and existing team members on these protocols and our business practices.
• Cross-Functional Collaboration: Coordinate reagent qualification activities with Operations personnel and communicate professionally with internal and external teams to ensure seamless production and delivery.

Qualifications:

• Education & Experience: A Bachelor's degree with a minimum of 5 years of relevant experience, or a Ph.D. or MS with a minimum of 2 years of relevant experience.
• Technical Skills: Strong knowledge of genomics and Next-Generation Sequencing (NGS) technologies is essential. Experience in authorship of SOPs is also a must.
• Leadership Skills: Previous supervisory experience is strongly preferred. You should also have a willingness to grow your leadership, interpersonal, and communication skills.
• Adaptability: A strong desire to work in a demanding, high-energy, hands-on startup environment is critical. You must be able to prioritize tasks, analyze workflows, and make swift, effective decisions.
• Quality Focus: Familiarity with CLIA/CAP/GLP and ISO 13485 requirements is a significant plus.

The hiring salary range for this position is $153,000 to $180,000, which may factor in various geographic regions. The offer will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contact you.

Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)

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