Company Description|Job Description
We believe conquering cancer is a big data problem. That's why we built the world's leading comprehensive liquid biopsy. This non-invasive tool for accessing & sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries & new products. We're working on some exciting ones, including in early detection, where the impact on patients can be profound. We've raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, & SoftBank.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development team is seeking a highly motivated, Manager of Reagent Development to lead successful technical delivery of IVD quality products related to liquid biopsy sequencing assays for the early detection, treatment, & monitoring of all cancer types. At Guardant, we leverage the most advanced technologies & work with leaders in many different fields to create the most impactful, meaningful, & scalable technologies for cancer management.
As the Manager of the Reagent Development Team, you will work closely with R&D teams to develop, implement, validate, & transfer reagent quality control testing methods & new manufacturing processes to support the IVD & LDT products. You will lead the team responsible for the maintenance & development of IVD & LDT products, working under design control in accordance with applicable regulatory requirements (CFRp11, ISO13485). In this role, you'll have the opportunity to collaborate with industry & thought leaders in assay development, bioinformatics, quality assurance, & regulatory affairs, & you'll take leadership role within the company to support reagent development for FDA submissions within an IVD framework.
We'll look to you to optimize complex problems at the interface of molecular biology, manufacturing, laboratory automation, quality assurance, regulatory affairs & operations. You'll influence & guide your team & your colleagues around designing & executing reagent process validations & developing new QC test methods.
- Provide technical direction & leadership around Process Validations for IVD reagent kits.
- Deliver well characterized, robust, & reliable manufacturing processes to allow sustainable production of high quality kits spanning from Sample Preparation to Sequencing.
- Structure manufacturing processes & documentation (Bills of Materials, Batch Records, Materials Receiving documentation, Work Instructions, etc).
- Establish specifications for new manufactured parts.
- Establish relationship between product performance, physical specifications, & manufacturing capabilities.
- Coordinate first prototype builds & pilot production builds with Reagent Operations.
- Ensure smooth transition of new products into Reagent Manufacturing through a defined operator training program.
- Project core team representative for Reagent Manufacturing NPI.
- Provide support for regulatory filings including drafting Chemistry, Manufacturing & Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
- Lead clinical materials manufacturing campaigns; responsible for oversight & coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager.
- Generate and/or review process risk assessments and/or process FMEAs & develop risk mitigation plans
- Acts as a mentor for the junior staff, provide coaching & emphasize best practices.
- May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring & retaining staff, career coaching, personal development for direct reports & accountable for the performance of employees. Ensure work completion within schedules & constraints.
- Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product & process related technical issues & provides technical support to Technical Operations, Manufacturing, Quality & Regulatory Affairs.
- Interacts with regulatory agencies, as needed basis.
- Communicates effectively to project manager & the wider development team & presents data at team meetings & departmental technical meetings.
- Ensure compliance with current Good Manufacturing Practices (CGMP), Perrigo policies & Quality Systems, & all applicable regulatory agencies.
- Provide leadership & technical direction for the Reagents & Consumables team.
- Develop & execute on strategy for scaling & COGS reduction.
- Deliver robust, efficient & well characterized manufacturing processes for reagents & kits.
- Work with the Product team to ensure reagents & kits meet customer needs.
- Ensure smooth transfer of processes to departments & end users.
- Serve as the key technical liaison for reagent vendors & contract manufacturers.
- Participate in auditing & qualifications of vendors & contract manufacturers
- Strong technical skills & broad knowledge in molecular biology & biochemistry (in particular, nucleic acids, DNA modifying enzymes, fluorophores, & formulation design/optimization). Knowledge of sequencing technologies & sequencing data analysis is a plus.
- Broad knowledge of analytical tools & assay development for molecular biology reagents.
- Broad knowledge of manufacturing systems (e.g. PLM system such as Agile, ERP system such as SAP) & reagent manufacturing operations.
- Well versed in statistical analysis tools to ensure the delivery of robust, reliable, & accurate processes to routine manufacturing.
- Proven track record of commercializing molecular biology reagents & completing projects on schedule.
- Detailed oriented manager who excels at data driven decision making, effective experimental designs, & ability to identify problems with concurrent development of corrective solutions.
- Effective verbal & written communication skills in the form of presentations, reports, & formal manufacturing documentation.
- Ability to lead & take independent initiative in an environment of fast pace innovation.
- Oversee studies aimed at improving & streamlining test assays & specifications in Reagent Manufacturing & QC
- Ensure all work is performed & documented in compliance with applicable regulatory & quality practices (FDA, ISO13485).
- Ph.D. in Molecular Biology, Biochemistry, or related scientific discipline.
- 5 + years of experience in commercial IVD assay product development & support, preferably in the area of genomics
- A minimum of 3 years leading & providing technical guidance to a Process Development team or NPI team in a relevant industry of Life Sciences, Medical Devices, or Diagnostics.
- Demonstrated success transferring processes for new IVD molecular diagnostic products into Reagent Manufacturing and/or QC laboratories
- Strong foundation in molecular biology techniques, with preferred experience in the areas of sample preparation for NGS.
- Demonstrated ability to organize, document & communicate scientific data
- Good communication & project management skills, appropriate for both leadership & individual contributor roles.
- Enjoy working independently & collaboratively in a fast-paced environment & able to adapt to change
- Knowledge of ISO9001 & ISO13485 a plus
Experience in the following areas is highly desirable:
- IVD product development for PMA submission
- Reagent stability, shipping & material compatibility studies
- Characterization of reagent performance at bench- & system level
- Development of reagent specifications & manufacturing release tests
All your information will be kept confidential according to EEO guidelines.