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Quality Microbiology Lead

MycoWorks

MycoWorks

Quality Assurance
Emeryville, CA, USA
Posted on Wednesday, June 21, 2023

We’re on a journey to Grow the Future of Materials. How? By unlocking the unique properties of mycelium, the root structure of mushrooms. Our patented technology, Fine Mycelium™, unleashes a new class of materials crafted from nature, engineered for performance, and built for a resilient future.We’re seeking passionate learners to join us in pioneering a materials revolution and creating an epic place to work. MycoWorks offers competitive equity and benefits programs to support the health, well-being, and financial empowerment of all our employees.We root our relationships with our partners and one another in our core values: Be Mycelial, Cultivate Quality, and Grow the Future, and we're committed to building a diverse team and an inclusive environment where all employees belong. Women, gender-expansive individuals, people of color, individuals with disabilities, veterans, and LGBTQ+ candidates are strongly encouraged to apply.

Job Summary

MycoWorks is seeking a person to fill the role of Quality Microbiology Lead. They will be responsible for taking ownership of systems and serving as subject matter expert for all quality microbiological sampling and testing, including raw materials, in-process materials and Environmental Monitoring. This position will also provide strategic guidance and support to both the Manufacturing and Technology Development teams in creating test protocols, planning testing, documenting processes and procedures and tracking results.

The role reports to the Senior Quality Manager and will work collaboratively with both Technology Development and Manufacturing.

Responsibilities:

  • Take leadership in managing technicians to ensure smooth operations
  • Build and execute systems for all aspects of micro sample collection, airborne contaminant monitoring, surface contaminant monitoring, contaminant identification and countermeasures
  • Provide technical training to functional team members on microbiological sampling and testing, media plating, enumeration, data reporting, etc.
  • Develop, implement, and maintain a comprehensive environmental monitoring program for the manufacturing plant and laboratories, focusing on strategic objectives
  • Establish and enforce standard operating procedures (SOPs) and protocols for microbiology testing and environmental monitoring activities aligning them with quality requirements and business objectives
  • Strategically design sampling plans for air, water, surfaces, and other critical areas as per regulatory and quality requirements
  • Oversee routine and non-routine environmental monitoring activities, including sample collection, data analysis, and result interpretation with a focus on system improvement
  • Provide framework for investigating and resolving deviations, non-conformances, and environmental excursions, implementing corrective and preventive actions (CAPAs)
  • Prepare and present reports summarizing sampling results, trends, and compliance status to relevant stakeholders, highlighting strategic insights
  • Identify areas for improvement and implement strategies to enhance the effectiveness and efficiency of environmental monitoring processes
  • Oversee inventory of media and material required and ensure supplies are ordered as necessary
  • Strategically schedule microbiology workload to meet department/site requirements
  • Lead and support gown qualification and gown training
  • Oversee SOP writing for lab operations, testing protocols, and test validation
  • Lead process and method validation, and development of analytical methods
  • Oversee and ensure the safety of lab operations including microbiological safety on a daily basis
  • Oversee lab equipment calibration and performance to ensure the accuracy of test results

Qualifications:

  • A minimum of a Bachelor's degree in Microbiology or a related scientific discipline is required. Equivalent experience may be accepted
  • Two to three years of previous experience as a lead is preferred
  • Five plus years of previous Lab Analyst, Technician, Lab Associate experience, preferably in a regulated environment - food, consumer products, life science, health
  • Experience designing and executing microbiological testing (i.e., total plate count), Environmental Monitoring Program, and scheduling
  • Experience with gowning procedures, aseptic technique and contamination control within a clean room environment is required
  • Familiarity with lab systems is preferred, LIMS, ELN, LES, sample management, instrument management, calibration scheduling and management
  • Excellent capability with MS Office / GSuite tools, data reporting and statistical analysis
  • Familiarity with statistical-guided experimental design and analysis (e.g. DoE) is a plus
  • Strong verbal and written communication skills
  • Good laboratory compliance and safety practices are a must

Our job titles may span more than one career level. The targeted base pay for this role is $86,000-$92,500 . The actual pay is dependent on other factors such as training, skills, work experience and business needs. The target pay range is subject to change and may be modified. This role is also eligible for benefits and equity.

#LI-JS

MycoWorks offers world class benefits and compensation programs to support the health, well-being and financial empowerment of our employees. Our benefits include:

  • Medical, Vision and Dental plans at no cost to employees
  • Equity
  • Optional insurance coverage for partners and dependents
  • FSA Accounts
  • Free Personal Health Advocate
  • Generous PTO policy
  • Paid parental leave
  • Paid holidays beyond the traditional
  • 401(k) program

MycoWorks may contact you via text message regarding your application for this or similar opportunities. You can always text STOP to opt out.