Associate Director, Quality Assurance GMP

2 months ago

South San Francisco, United States Kanvas Biosciences Full time

About Us 

 

Kanvas Biosciences is a biotechnology company dedicated to studying and leveraging the microbiome towards developing next-generation treatment strategies. As a leader in microbial imaging and therapeutics, we're passionate about illuminating host-microbiome interactions with our advanced microscopy tools and leveraging them to create the next generation of therapeutics. Our mission at Kanvas is to characterize the microbiome and help unlock its potential as a druggable organ system. We are passionate about understanding how these microbial organisms work together, how they can be harnessed to improve human health and the environment, and how we can use our knowledge to make a meaningful impact in the world. 

 

Our Values 

 

  1. We hire good people who are also great scientists. Kanvas is fortunate enough to have world-class scientists leading its R&D and scientific programs. But their unique talent is not the only reason they were hired. We strongly value integrity, honesty, dedication, and sportsmanship as critical traits in our team members.  
  2. We think like explorers. We recognize that we are trying to do something that has never been done before. While these new frontiers excite us, we are also cognizant of the magnitude of the challenges ahead. As we navigate uncharted territories, we devote the necessary preparation, creativity, and effort required to achieve our goals.  
  3. We have a steadfast commitment to the team. We believe that our collective knowledge, experience, and talent is enough to overcome any problem. We put our team members in the best positions for them to succeed and will be there to support them regardless of the outcome.  
  4. We believe there is power in diversity. This statement applies both to the microbiome we study and also encoded in our team and culture. The members of Kanvas represent different ages, races, nationalities, genders, identities, and orientations. We view these differences as a strength because different vantage points fuel our scientific discoveries and fortify our company culture. 

  

Research at Kanvas 

 

Kanvas is a full-stack microbiome therapeutics company with cutting-edge biotech company at the forefront of microbial imaging. Our team of microbiologists, physicists, engineers, and geneticists are dedicated to developing the next generation of imaging tools that allow us to study microbes and host-microbiome interactions in their native biological environments. We use the principles of HiPR-FISH assay to explore the microbiome in various contexts and design the next generation of live therapeutics. Our state-of-the-art research facility in Princeton, NJ, is equipped with advanced technology for microscopy, image processing, aerobic and anaerobic microbial culture, tissue processing, and molecular biology. Our findings inform the manufacture of novel live biotherapeutics, which are produced in our laboratory in South San Francisco, CA. Our team members have access to dedicated spaces where they can perform their work in a collaborative and supportive environment.  

 

Job Description 

 

We are seeking an experienced and dedicated Associate Director of Quality Assurance to join our dynamic team. Reporting to the Head of Regulatory and Quality Assurance, the Associate Director will assist in the quality oversight and management of GxP activities internally and externally with vendors. The ideal candidate will have extensive quality assurance experience within the biotech/pharmaceutical sector, will be a fast learner and self-motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail and should thrive in a busy, fast-paced environment. The successful candidate will play a critical role in maintaining the quality standards of our live biotherapeutic products (LBPs) and ensuring compliance with industry and regulatory guidelines. 

 

Key Responsibilities: 

 

As Associate Director in GMP Quality Assurance, your responsibilities will include: 

.  

  • Managing the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release. 
  • Maintaining the Quality Management System and assist in the development and maintenance of GxP SOPs and electronic systems. 
  • Reviewing and approving validation protocols, quality agreements, and other technical documents. 
  • Collaborating with cross-functional teams to address and resolve quality issues promptly. 
  • Assisting in establishing and ongoing management of vendor relationships.  
  • Overseeing the development and implementation of quality assurance policies and procedures to ensure product quality and regulatory compliance. 
  • Providing quality assurance input for the development and manufacturing of our LBPs products. 
  • Preparing and present quality reports to senior management 
  • Performing other duties as assigned by the Head of Regulatory and Quality Assurance. 

 

Ideal Candidate Profile 

 

We are seeking candidates who have a Bachelor’s degree in a scientific discipline and a minimum of 10 years of experience in Quality Assurance within the biotechnology or pharmaceutical industry, with a minimum of 6 years within GMP. The role requires the following experience and key qualifications: 

 

  • Experience with an electronic quality management system, ACE Essentials being preferred but not necessary. 
  • Strong knowledge of FDA, EMA, and ICH guidelines. 
  • Proven leadership and team management skills. 
  • Excellent problem-solving and decision-making abilities. 
  • Ability to manage multiple priorities in a dynamic, fast-paced development environment.  
  • Strong communication and interpersonal skills. 

 

We expect the candidate filling this position to be physically present at our office to best be an integral part of our team's ongoing research efforts. 

 

At Kanvas, we offer a competitive salary and benefits package that includes full medical, dental, and vision insurance packages for employees and their families, and paid time off.  

 

If you're passionate about biotech and want to join a dynamic and innovative team, we encourage you to apply for this exciting opportunity.

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