Gameto
Overview
Gameto is seeking an experienced and highly organized CMC Program Manager to join our mission-driven team. This role offers an exciting opportunity to help shape the future of women’s health by leading cross-functional Chemistry, Manufacturing, and Controls (CMC) initiatives in support of our groundbreaking cell-based therapies. You will be instrumental in driving successful execution of CMC deliverables, collaborating with both internal teams and external partners to advance our clinical programs and ensure regulatory readiness. If you're an agile program manager with strong communication and organizational skills, and thrive at the interface of science, operations, and strategy, this is your opportunity to make a global impact. Base pay range
$100,000.00/yr - $130,000.00/yr Additional compensation
Annual Bonus Location:
Austin, Texas or New York City, USA Compensation Range:
$100,000-$130,000 About the Role
As the CMC Program Manager, you will serve as a key point of coordination between internal functional teams and external collaborators, including CDMOs and analytical vendors. Your primary responsibility will be to lead CMC planning and execution, from clinical trial supply activities to regulatory filings, ensuring alignment with strategic goals and timelines. You’ll track progress, identify risks, manage budgets, and provide clear communication across stakeholders. We are looking for a proactive, solutions-oriented individual with a strong foundation in project management and a working knowledge of CMC activities and regulatory expectations. Key Responsibilities
Coordinate and manage CMC activities across internal departments, including Quality, Regulatory, Process Development, and Supply Chain. Serve as the main point of contact for external partners, including CDMOs and analytical vendors, ensuring consistent communication and follow-through. Develop and maintain integrated timelines, project plans, and risk registers for all CMC deliverables, ensuring cross-functional accountability. Monitor and support execution of key milestones related to manufacturing, analytical development, and product release. Facilitate internal alignment across cross-functional teams to drive decision-making and mitigate delays. Lead regular program update meetings with internal stakeholders and report on progress, risks, and mitigation strategies to executive leadership. Track action items, vendor deliverables, change controls, ensuring all documentation is current and audit-ready. Support regulatory documentation and submissions, such as INDs, IMPDs, and BLAs, by coordinating CMC content and timelines. Qualifications
Bachelor’s degree in life sciences, engineering, or a related field required; advanced degree or PMP certification a plus. 1–3 years of experience in project/program management of a biologic product, preferably within a biotech or pharmaceutical environment. Prior experience leading external partnerships and managing deliverables from CDMOs or other vendors. Familiarity with CMC regulatory deliverables (e.g., IND, IMPD, BLA) and the development lifecycle of cell or gene therapy products is preferred. Strong written and verbal communication skills, with the ability to manage up and across teams. Highly organized with a proven ability to manage multiple priorities and drive complex projects to completion. A self-starter with a collaborative spirit and a passion for advancing health innovation. How to Apply
If you are excited about advancing women’s health through cutting-edge science and want to be part of a mission-driven team, we encourage you to apply today! Please apply on LinkedIn and with the following materials together in a single PDF document: A cover letter that: Explains your experience with CMC and program management Highlights your strengths relevant to this role Shares your interest in Gameto and anticipated start date Includes anything else you'd like us to know CV/resume Why Join Us?
As an CMC Program Manager at Gameto, you will work alongside world-class scientists, pushing the boundaries of research in women’s health. Your work will play a pivotal role in transforming the treatment of menopause and contributing to innovations that impact women globally. You will have the opportunity to shape new frontiers in cell therapy and develop your career within a vibrant and mission-driven organization. About Gameto
Gameto is a pioneering biotechnology company in women’s health, co-founded by Dina Radenkovic, a physician-turned-entrepreneur, and Martin Varsavsky, a leader in fertility innovation and founder of the Prelude Network. With our groundbreaking cell engineering platform—developed through a collaboration with Harvard University’s Wyss Institute and Professor George Church’s lab at Harvard Medical School—we aim to create treatments for menopause and infertility affecting the female reproductive system. Our scientific approach surpasses traditional therapeutic modalities and sets a new gold standard for research and development in the field. Backed by $73 million raised in Series A and B funding from Insight Partners, Future Ventures, RA Capital, Two Sigma Ventures, Lux Capital, and others as well as $10 million from ARPA-H, Gameto is committed to transforming women's healthcare through bold innovation. Read about us in: MIT Technology Review, The New Yorker, The Boston Globe, and Stat News. Our Values and Commitment to Diversity
At Gameto, we value kindness, collaboration, authenticity, and diversity. We are an equal opportunity employer and are committed to creating an inclusive environment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Manufacturing and Product Management Benefits
Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave
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Gameto is seeking an experienced and highly organized CMC Program Manager to join our mission-driven team. This role offers an exciting opportunity to help shape the future of women’s health by leading cross-functional Chemistry, Manufacturing, and Controls (CMC) initiatives in support of our groundbreaking cell-based therapies. You will be instrumental in driving successful execution of CMC deliverables, collaborating with both internal teams and external partners to advance our clinical programs and ensure regulatory readiness. If you're an agile program manager with strong communication and organizational skills, and thrive at the interface of science, operations, and strategy, this is your opportunity to make a global impact. Base pay range
$100,000.00/yr - $130,000.00/yr Additional compensation
Annual Bonus Location:
Austin, Texas or New York City, USA Compensation Range:
$100,000-$130,000 About the Role
As the CMC Program Manager, you will serve as a key point of coordination between internal functional teams and external collaborators, including CDMOs and analytical vendors. Your primary responsibility will be to lead CMC planning and execution, from clinical trial supply activities to regulatory filings, ensuring alignment with strategic goals and timelines. You’ll track progress, identify risks, manage budgets, and provide clear communication across stakeholders. We are looking for a proactive, solutions-oriented individual with a strong foundation in project management and a working knowledge of CMC activities and regulatory expectations. Key Responsibilities
Coordinate and manage CMC activities across internal departments, including Quality, Regulatory, Process Development, and Supply Chain. Serve as the main point of contact for external partners, including CDMOs and analytical vendors, ensuring consistent communication and follow-through. Develop and maintain integrated timelines, project plans, and risk registers for all CMC deliverables, ensuring cross-functional accountability. Monitor and support execution of key milestones related to manufacturing, analytical development, and product release. Facilitate internal alignment across cross-functional teams to drive decision-making and mitigate delays. Lead regular program update meetings with internal stakeholders and report on progress, risks, and mitigation strategies to executive leadership. Track action items, vendor deliverables, change controls, ensuring all documentation is current and audit-ready. Support regulatory documentation and submissions, such as INDs, IMPDs, and BLAs, by coordinating CMC content and timelines. Qualifications
Bachelor’s degree in life sciences, engineering, or a related field required; advanced degree or PMP certification a plus. 1–3 years of experience in project/program management of a biologic product, preferably within a biotech or pharmaceutical environment. Prior experience leading external partnerships and managing deliverables from CDMOs or other vendors. Familiarity with CMC regulatory deliverables (e.g., IND, IMPD, BLA) and the development lifecycle of cell or gene therapy products is preferred. Strong written and verbal communication skills, with the ability to manage up and across teams. Highly organized with a proven ability to manage multiple priorities and drive complex projects to completion. A self-starter with a collaborative spirit and a passion for advancing health innovation. How to Apply
If you are excited about advancing women’s health through cutting-edge science and want to be part of a mission-driven team, we encourage you to apply today! Please apply on LinkedIn and with the following materials together in a single PDF document: A cover letter that: Explains your experience with CMC and program management Highlights your strengths relevant to this role Shares your interest in Gameto and anticipated start date Includes anything else you'd like us to know CV/resume Why Join Us?
As an CMC Program Manager at Gameto, you will work alongside world-class scientists, pushing the boundaries of research in women’s health. Your work will play a pivotal role in transforming the treatment of menopause and contributing to innovations that impact women globally. You will have the opportunity to shape new frontiers in cell therapy and develop your career within a vibrant and mission-driven organization. About Gameto
Gameto is a pioneering biotechnology company in women’s health, co-founded by Dina Radenkovic, a physician-turned-entrepreneur, and Martin Varsavsky, a leader in fertility innovation and founder of the Prelude Network. With our groundbreaking cell engineering platform—developed through a collaboration with Harvard University’s Wyss Institute and Professor George Church’s lab at Harvard Medical School—we aim to create treatments for menopause and infertility affecting the female reproductive system. Our scientific approach surpasses traditional therapeutic modalities and sets a new gold standard for research and development in the field. Backed by $73 million raised in Series A and B funding from Insight Partners, Future Ventures, RA Capital, Two Sigma Ventures, Lux Capital, and others as well as $10 million from ARPA-H, Gameto is committed to transforming women's healthcare through bold innovation. Read about us in: MIT Technology Review, The New Yorker, The Boston Globe, and Stat News. Our Values and Commitment to Diversity
At Gameto, we value kindness, collaboration, authenticity, and diversity. We are an equal opportunity employer and are committed to creating an inclusive environment. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Manufacturing and Product Management Benefits
Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave
#J-18808-Ljbffr