Manager, Quality Control

Company: Pendulum---
Location: San Francisco
Posted on: November 18, 2024

Job Description:

About Pendulum:Pendulum is leading a revolution that is occurring around the world to improve physical and mental health by first understanding, then restoring and enhancing the human microbiome.Studies have shown that our microbiome (the bacterial communities in and on our bodies) is linked to everything from metabolism and diabetes, to longevity, weight loss, healthy immune systems, cancer prevention, feelings of well-being, inflammatory bowel disease, and even healthy skin. We have just scratched the surface on understanding the impact that our microbiome has on our lives. During early life we develop a diverse and balanced microbiome that plays a critical role in shaping our long-term health. Over our lives, a combination of diet, lifestyle, antibiotics, and aging can decrease the effectiveness of our microbiome.Pendulum recognized the enormous impact they could have on people's lives if they were able to address the imbalances in the microbiome. To accomplish this, Pendulum created proprietary probiotic pipelines and a unique discovery platform to identify key, novel bacterial strains and the prebiotics that feed them. The company has also built and developed the world's first manufacturing technology to produce bacteria in an anaerobic (oxygen-free) environment at scale.The medical probiotics that Pendulum has formulated have transformed the consumer probiotics market into a new category of therapeutic offerings that deliver the power and efficacy of a pharmaceutical with the safety and accessibility of a natural probiotic. Due to Pendulum's explosive revenue and customer growth over the last two years, the company earned a spot on Forbes Magazine's exclusive "The Next Billion Dollar Startups" list.If you're interested in improving the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading.Position Summary:We are seeking a Manager, Quality Control to lead our quality control efforts in the live probiotic space. This person will be responsible for overseeing stability and viability testing, utilizing their expertise in microbiology and flow cytometry. The ideal candidate will ensure the highest quality standards are maintained throughout our product lifecycle, from development to production and distribution.What You'll Do:

• Manage and develop the Quality Control team, fostering a culture of excellence and continuous improvement.
• Be responsible for management of the daily activities of Quality Control functions pertaining to product testing and release.
• Oversee stability and viability testing programs for live probiotic products.
• Develop and implement quality control protocols and standard operating procedures (SOPs).
• Utilize flow cytometry and other advanced techniques to assess product quality and consistency.
• Provide quality oversight for qualification and validation activities including protocol generation, execution, and final report documentation.
• Evaluate methods being transferred to QC and design experiments to support validation activities.
• Analyze and interpret quality control data, preparing comprehensive reports for management.
• Serve as the main point of contact for external laboratories for activities related to onboarding, communicating discrepancies, investigations, and standardizing methodology.
• Ensure compliance with cGMP regulations and industry standards.
• Participate in regulatory inspections and internal audits.
• Drive process improvements to enhance efficiency and accuracy in quality control operations.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Compile and analyze KPIs indicative of production line health and drive improvement actions.
• Troubleshoot non-conformances, drive root cause analysis, and implement corrective actions.
• Provide training and mentoring to operations teams on food safety and quality-related topics.Knowledge Requirements:
  • Bachelor's degree in Microbiology, Biology, or a related field; Master's degree preferred.
  • Minimum of 7 years of quality control experience in the pharmaceutical, biotechnology, or probiotic industry, with at least 3 years in a managerial role.
  • Extensive knowledge of microbiology techniques, with a focus on probiotic organisms.
  • Proven expertise in flow cytometry and its application in assessing microbial viability.
  • Strong understanding of cGMP regulations and quality management systems.
  • Experience with stability testing programs and data analysis.
  • Proficient in general and non-routine laboratory skills.
  • Experience in assay qualification and validation.
  • Knowledge and understanding of US regulations and guidance applicable to Quality Control and method validation.
  • Strong analytical and problem-solving abilities.
  • Proficiency in statistical analysis and quality control software.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
  • Experience using structured and data-driven problem-solving techniques.
  • Established project management skills.
  • Willingness to work flexible schedules as needed to support production facilities.Salary & Benefits
    • $100,000 - $125,000.
    • Medical, Dental, and Vision.
    • Commuter Benefits.
    • Life & STD Insurance.
    • Company match on 401 (k).
    • Flexible Time Off (FTO).
    • Equity.
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Keywords: Pendulum---, Fremont , Manager, Quality Control, Executive , San Francisco, California