Vice President, Chemistry, Manufacturing, and Controls (CMC) - Gene Editing
Brisbane, CA, USA
Posted on Friday, May 26, 2023
We are currently seeking a highly skilled and experienced Vice President, CMC to join our dynamic team. In this role, you will be responsible for overseeing all aspects of the chemistry, manufacturing, and controls process for our gene editing programs, ensuring the highest standards of quality, safety, and efficacy.
- Develop and implement comprehensive CMC strategies for our gene editing programs, including LNP, mRNA, AAV, and gRNA technologies
- Oversee the design, development, and optimization of scalable manufacturing processes, in collaboration with internal and external partners
- Ensure compliance with all relevant regulatory guidelines and requirements, including FDA, EMA, and ICH guidelines for gene editing products
- Collaborate with cross-functional teams, including research and development, clinical, regulatory, and quality, to advance product development and ensure successful regulatory submissions
- Manage relationships with contract manufacturing organizations (CMOs), contract research organizations (CROs), and other external partners to ensure the timely delivery of high-quality materials for preclinical and clinical studies
- Lead and mentor a team of CMC professionals, fostering a culture of continuous improvement, innovation, and scientific excellence
- Evaluate and implement novel technologies and processes to enhance product quality, manufacturing efficiency, and cost-effectiveness
- Develop and manage budgets, timelines, and resources for CMC activities, ensuring projects are completed on time and within budget
- Maintain up-to-date knowledge of the latest advancements in gene editing technologies and regulatory landscape, and apply this knowledge to inform and guide CMC strategies
- Master’s or PhD in Molecular Biology, Biochemistry, Biotechnology, or a related field
- A minimum of 12 years experience in the biotechnology or pharmaceutical industry, with a focus on CMC and gene therapy product development; 10 years experience with a PhD
- Expertise in LNP, mRNA, AAV, and gRNA technologies, and a deep understanding of the manufacturing and regulatory requirements for gene editing products
- Proven track record of successful regulatory submissions and approvals for genomic medicine INDs
- Strong leadership and team management skills, with the ability to inspire, motivate, and mentor a diverse team of professionals
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners
- Strong analytical and problem-solving skills, with a keen attention to detail and a commitment to quality
- Company-paid health/vision/dental benefits
- Unlimited vacation and generous sick time
- Company-sponsored meals and snacks
- Wellness, caregiver and ergonomics benefits
- 401(k) with company matching
Salary Range: $275,000 - $325,000
The listed base salary range is for Mammoth employees in the Bay Area. Actual base salary will be determined by geographic work location, relevant professional experience, applicable skills, and internal equity. The base salary range for those working remotely outside of the San Francisco Bay Area may differ and will be determined by industry market data for the role and specific region.
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.
Mammoth Biosciences requires that all employees be vaccinated against COVID-19 as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law.
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