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Manager / Senior Manager, CMC

Boston, MA

About us:

Ascidian is redefining the treatment of disease by rewriting RNA.

Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via trans-splicing and alternative splicing.

In our Brighton/Boston labs, RNA biology meets today’s cutting-edge genomics, computational biology, and deep-sequencing technologies to create a new class of medicines that address the underlying causes of disease. We welcome you to come join our vibrant team and help us lead the way into a new gene therapy era.

About the Role

As a Manager/Senior Manager, CMC at Ascidian Therapeutics, you will be a pivotal contributor in advancing our groundbreaking RNA editing therapies. You'll take on a strategic and comprehensive role in managing and overseeing all aspects of CMC (Chemistry, Manufacturing, and Controls) activities, starting with supporting GLP-tox studies and continuing through clinical supply. For a Senior Manager, this role will specifically involve leading critical initiatives such as clinical re-supply campaigns, ensuring direct and significant impact on clinical trial continuity. You will develop robust CMC strategies, expertly manage complex external manufacturing partnerships, and ensure the timely and high-quality supply of our innovative drug products for toxicology studies and clinical trials. This is a critical opportunity to shape the CMC landscape of an early-phase company at the forefront of genetic medicine, with significant impact on our pipeline's success.

Key Responsibilities

  • Strategic CMC Leadership:
    • Contribute to (Manager) / Lead and execute (Senior Manager) comprehensive CMC strategies for Ascidian's pipeline programs, encompassing drug substance and drug product development, manufacturing, and supply chain, specifically from GLP-tox material supply through clinical trial material supply.
    • (Senior Manager only): Directly manage and ensure the successful execution of clinical re-supply campaigns, meeting critical timelines and quality requirements.
    • Proactively identify and mitigate CMC risks, developing contingency plans to ensure program continuity and success.
    • Contribute significantly to (Manager) / Shape and drive (Senior Manager) the overall technical and operational strategy of the CMC function within the company.
  • External Manufacturing Partner Management:
    • Oversee (Manager) / Independently select, onboard, and critically oversee (Senior Manager) external CDMOs (Contract Development and Manufacturing Organizations) for all manufacturing activities, including complex tech transfers, process development, cGMP manufacturing, and release testing, for both GLP-tox and clinical materials.
    • (Senior Manager only): Serve as the primary liaison with CDMOs for clinical re-supply operations, ensuring clear communication, oversight, and timely delivery.
    • Support (Manager) / Lead (Senior Manager) joint process development and manufacturing teams with CDMOs, troubleshooting complex technical issues and driving continuous improvement initiatives.
    • Manage multi-faceted CDMO relationships, ensuring strong communication, accountability, and performance against demanding timelines and budgets.
  • Process Development & Optimization Expertise:
    • Provide guidance and hands-on oversight to define, develop, and optimize manufacturing processes for AAV-based therapeutics, ensuring processes are robust, scalable, and cost-effective for use in GLP-tox and clinical studies.
    • Drive the evaluation and implementation of new technologies to enhance manufacturing efficiency, product quality, and compliance.
  • Supply Chain Management:
    • Develop and manage strategic raw material sourcing, inventory, and logistics to establish a resilient and efficient supply chain for GLP-tox and clinical product needs.
    • (Senior Manager only): Optimize supply chain logistics specifically for clinical re-supply campaigns, ensuring continuous and uninterrupted product flow to clinical sites.
    • Anticipate future supply needs and proactively establish agreements and strategies to meet program milestones.
  • Cross-Functional & External Collaboration:
    • Serve as a primary CMC point of contact, fostering strong collaborative relationships with internal cross-functional teams (Research, Preclinical, Clinical, Quality, Project Management, Regulatory) and external partners.
    • Communicate complex CMC updates, risks, and strategies effectively to senior leadership and broader project teams.
  • Problem-Solving & Innovation:
    • Lead the resolution of complex CMC challenges, applying advanced problem-solving techniques and fostering an innovative approach to overcome technical hurdles.
    • Drive continuous improvement in CMC processes and operations.

Qualifications

  • Bachelor's or Master's degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
  • Minimum of 6+ years of progressive experience in the biopharmaceutical industry.
    • For Manager level: At least 6+ years focused on CMC development and manufacturing.
    • For Senior Manager level: At least 10+ years focused on CMC development and manufacturing, specifically supporting non-GMP/GLP-tox material generation through clinical trial material supply.
  • Demonstrated expertise in biologics or nucleic acid-based therapeutics CMC development, encompassing both drug substance and drug product manufacturing.
  • Experience in working with and managing external CDMOs is essential, including contract negotiation support and performance oversight for GLP-tox and clinical programs. (Independent management/leadership of CDMOs is expected for Senior Manager).
  • (Senior Manager only): Demonstrated experience in managing and successfully executing clinical re-supply campaigns is highly desirable.
  • Deep understanding of cGMP and GLP regulations and quality systems for pharmaceutical manufacturing, with a proven ability to ensure compliance.
  • Strong project management skills, including the ability to manage multiple complex projects simultaneously and drive them to successful completion.
  • Exceptional communication, interpersonal, and negotiation skills, with the ability to influence and collaborate effectively across all levels of an organization and with external partners. (Stronger leadership and influence expected for Senior Manager).
  • Proven ability to work independently, make critical decisions (Senior Manager) / contribute (Manager), and lead initiatives (Senior Manager) / support initiatives (Manager) in a fast-paced, highly dynamic, and evolving early-stage environment.
  • Strong analytical and problem-solving abilities, with a proactive and results-oriented approach.

Why Join Ascidian?

At Ascidian Therapeutics, you’ll be part of a team that is redefining the future of medicine. We offer:

  • A challenging and rewarding role in a collaborative and innovative work environment where your contributions will directly drive the progress of our groundbreaking RNA editing programs from preclinical development through clinical supply.
  • The unique opportunity to lead critical projects (Senior Manager) / contribute to critical projects (Manager) and shape the development of transformative therapies for patients.
  • Competitive compensation and benefits package, including comprehensive health coverage, generous paid time off, and stock options.
  • Significant professional development opportunities to support your continued growth and career advancement.

If you are a driven and visionary CMC professional ready to make a profound impact in a rapidly evolving field, we encourage you to apply!

Ascidian Therapeutics is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit, and business need.

Benefits:

We provide a vibrant startup environment where every employee contributes to our culture and science. We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits. Our benefits include a top-tier health and wellness plan, commuter reimbursement or paid monthly parking, tuition or loan reimbursement, career development opportunities and so much more.

A final note - we highly encourage you to apply for our position, even if you are not sure you meet all the requirements. Everyone has unique talents, and at Ascidian, we look not only at your experience but your potential. We know that the best teams consist of diverse backgrounds, so please apply!

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