Tbwa Chiat/Day Inc
Head of Analytical Development and Quality Control Emeryville, California, Unite
Tbwa Chiat/Day Inc, Emeryville, California, United States, 94608
Head of Analytical Development and Quality Control
Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world.Whether it's the biological diversity of our gene editing systems or the people that help discover them, Metagenomi celebrates the diversity of life. This is achieved through a compassionate culture that acknowledges the dimensions of our diversity. We know that when people feel a sense of inclusion and belonging in the workplace, they have a safe space to bring creativity and innovation to everything they do. We are intentional about building and maintaining a culture where people are valued and respected, there is equity in opportunities, and our respective opinions and differences matter.Position Overview:Metagenomi is seeking an experienced analytical scientist and leader to head our Analytical Sciences and Quality Control (ASQC) function with broad accountability for complex biologicals, including plasmid DNA, mRNA, lipid nanoparticles, proteins, and viral vectors. The ideal candidate will bring deep expertise in developing, qualifying, and implementing phase-appropriate analytical methods and testing strategies, provide strategic leadership across our internal and external analytical activities and strong organizational leadership. This role is critical to ensuring that Metagenomi’s products meet the highest standards of quality, compliance, and scientific rigor.What You’ll Do:Strategic Leadership:
Establish and lead the ASQC strategy, including tactics, timelines, budgets, and resource allocation. Build and mentor high-performing teams, proactively identify and resolve critical analytical issues, and support talent development and engagement.Analytical Development:
Develop and qualify phase-appropriate methods for release, characterization, and stability of complex biologicals, utilizing state-of-the-art technologies and approaches. Oversee the qualification, transfer, and execution of analytical and bioanalytical assays, ensuring compliance with cGMP regulations and ICH guidelines.Lifecycle Management:
Provide strategic oversight for the design, establishment, and execution of processes and procedures for the lifecycle management of analytical methods for clinical and commercial product testing. Drive the strategy for product quality assessment, analytical comparability, and characterization.Regulatory Expertise:
Author and review relevant CMC sections of regulatory submissions, serving as an analytical subject matter expert in regulatory interactions. Draft guidelines and set release and stability specifications for clinical-stage and commercial programs.Cross-functional Collaboration:
Partner with internal and external stakeholders to lead Quality Target Product Profile and product characterization strategy, enhancing process-to-product understanding and supporting process development and characterization.Required Qualifications:Ph.D. in Biochemistry, Analytical Chemistry, Microbiology, Genetics, or a related life sciences discipline.At least 15 years of experience in analytical development and quality control within the biotech industry.Industry experience managing scientific teams with a proven ability to lead and grow strong technical teams.Extensive industry experience with nucleic acids, viral vectors, lipid nanoparticles, and complex biologicals.Demonstrated expertise in cGMP regulations, ICH guidelines, and USP standards, and their application in clinical development and commercialization.Skills and Abilities:Proven ability to build and lead masterful and impactful teams.Advanced strategic thinking with a focus on product quality assessment, analytical comparability, and characterization.Proven project management skills, including managing timelines, budgets, and resources.Excellent communication skills, both written and verbal, with experience in authoring and reviewing regulatory submissions, SOPs, and technical documents.Strong problem-solving skills, with the ability to resolve complex issues and drive innovative solutions.Under the Federal Labor Standards Act, this position is classified as exempt. Its anticipated base salary range will be $220,000 to $320,000. Depending on the position offered, you will also be eligible to receive equity, bonuses, and a full range of benefits. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.What makes Metagenomi a unique place to work?We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating diseases.We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more!We offer competitive compensation, including a market-benchmarked salary, annual target bonus potential, equity, comprehensive benefits plan, 401(k) with company matching, retirement safe harbor plan, and other perks.At Metagenomi, we know that our people drive our success. We are an equal opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law.
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Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world.Whether it's the biological diversity of our gene editing systems or the people that help discover them, Metagenomi celebrates the diversity of life. This is achieved through a compassionate culture that acknowledges the dimensions of our diversity. We know that when people feel a sense of inclusion and belonging in the workplace, they have a safe space to bring creativity and innovation to everything they do. We are intentional about building and maintaining a culture where people are valued and respected, there is equity in opportunities, and our respective opinions and differences matter.Position Overview:Metagenomi is seeking an experienced analytical scientist and leader to head our Analytical Sciences and Quality Control (ASQC) function with broad accountability for complex biologicals, including plasmid DNA, mRNA, lipid nanoparticles, proteins, and viral vectors. The ideal candidate will bring deep expertise in developing, qualifying, and implementing phase-appropriate analytical methods and testing strategies, provide strategic leadership across our internal and external analytical activities and strong organizational leadership. This role is critical to ensuring that Metagenomi’s products meet the highest standards of quality, compliance, and scientific rigor.What You’ll Do:Strategic Leadership:
Establish and lead the ASQC strategy, including tactics, timelines, budgets, and resource allocation. Build and mentor high-performing teams, proactively identify and resolve critical analytical issues, and support talent development and engagement.Analytical Development:
Develop and qualify phase-appropriate methods for release, characterization, and stability of complex biologicals, utilizing state-of-the-art technologies and approaches. Oversee the qualification, transfer, and execution of analytical and bioanalytical assays, ensuring compliance with cGMP regulations and ICH guidelines.Lifecycle Management:
Provide strategic oversight for the design, establishment, and execution of processes and procedures for the lifecycle management of analytical methods for clinical and commercial product testing. Drive the strategy for product quality assessment, analytical comparability, and characterization.Regulatory Expertise:
Author and review relevant CMC sections of regulatory submissions, serving as an analytical subject matter expert in regulatory interactions. Draft guidelines and set release and stability specifications for clinical-stage and commercial programs.Cross-functional Collaboration:
Partner with internal and external stakeholders to lead Quality Target Product Profile and product characterization strategy, enhancing process-to-product understanding and supporting process development and characterization.Required Qualifications:Ph.D. in Biochemistry, Analytical Chemistry, Microbiology, Genetics, or a related life sciences discipline.At least 15 years of experience in analytical development and quality control within the biotech industry.Industry experience managing scientific teams with a proven ability to lead and grow strong technical teams.Extensive industry experience with nucleic acids, viral vectors, lipid nanoparticles, and complex biologicals.Demonstrated expertise in cGMP regulations, ICH guidelines, and USP standards, and their application in clinical development and commercialization.Skills and Abilities:Proven ability to build and lead masterful and impactful teams.Advanced strategic thinking with a focus on product quality assessment, analytical comparability, and characterization.Proven project management skills, including managing timelines, budgets, and resources.Excellent communication skills, both written and verbal, with experience in authoring and reviewing regulatory submissions, SOPs, and technical documents.Strong problem-solving skills, with the ability to resolve complex issues and drive innovative solutions.Under the Federal Labor Standards Act, this position is classified as exempt. Its anticipated base salary range will be $220,000 to $320,000. Depending on the position offered, you will also be eligible to receive equity, bonuses, and a full range of benefits. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.What makes Metagenomi a unique place to work?We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating diseases.We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun. We have a strong commitment to work/life balance, host a weekly employee happy hour and events, provide catered lunches and endless snacks, and more!We offer competitive compensation, including a market-benchmarked salary, annual target bonus potential, equity, comprehensive benefits plan, 401(k) with company matching, retirement safe harbor plan, and other perks.At Metagenomi, we know that our people drive our success. We are an equal opportunity employer and believe in and value diversity and inclusion. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. Metagenomi does not discriminate on the basis of race, color, religion, sexual orientation, gender, age, physical or mental disability, or any other status protected under federal, state, or local law.
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