Sr. Manager, CMC Project Management

Genetix Biotherapeutics

$136K — $179K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's, Master's, or Ph.D. in life sciences or a related field, or equivalent experience.
  • Minimum of 6 years in the biopharmaceutical industry, particularly with late-stage or commercial programs.
  • At least 2 years in project management or leading cross-functional teams in a biotech environment.
  • Evidence of managing complex programs and risk mitigation in a matrixed setting.
  • Strong knowledge of CMC development and quality concepts; experience in cell and gene therapy is a plus.
  • Proficiency in project management tools like Microsoft Project and Excel.
  • Exceptional organizational skills and capability to handle multiple priorities.

Responsibilities

  • Lead Commercial CMC teams to execute aligned CMC activities.
  • Develop and manage integrated CMC project plans with timelines and critical path activities.
  • Establish and manage a CMC risk registry while proactively identifying risks.
  • Coordinate cross-functional teams to resolve complex CMC issues efficiently.
  • Collaborate with external partners to ensure accountability for commercial milestones.
  • Deliver data-driven updates to senior leadership on CMC status and execution options.
  • Facilitate CMC team meetings for effective decision-making and accountability.

Benefits

  • Comprehensive health, life, and disability insurance.
  • Employer-matched 401(k) plan.
  • Flexible time-off plus paid holidays and a winter holiday period.
  • Tuition reimbursement and loan repayment assistance.
  • Paid parental leave and paid onsite parking.
  • Commuter subsidy and lifestyle spending account.
Full Job Description
The CMC Project Manager is responsible for driving cross-functional execution of Commercial CMC programs for approved cell and gene therapy products. This role partners closely with CMC functional leaders and teams to ensure disciplined planning, risk management, and delivery of post-approval commitments that support uninterrupted commercial supply.

A primary focus of the role will be leading a CMC sub-team, including coordination with an external partners, to deliver a critical commercial milestones. This position operates in a highly matrixed environment and requires strong project leadership, clear communication, and the ability to manage complex interdependencies across CMC functions.

This role is a full time hybrid position (3 days a week in the office) located in our Somerville, Massachusetts office.

RESPONSIBILITIES
  • Lead Commercial CMC teams and drive execution of CMC activities aligned with program, regulatory, and supply objectives
  • Develop, maintain, and actively manage integrated CMC project plans, including timelines, dependencies, critical path activities, and decision points
  • Establish and maintain a CMC risk registry; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays
  • Lead cross-functional coordination across Manufacturing, Quality, Analytical Development, Regulatory CMC, Supply Chain, and external partners to resolve complex CMC issues
  • Manage CMC execution in collaboration with key external partners, ensuring accountability to scope, timeline, and deliverables for key commercial milestones
  • Prepare and deliver concise, data-driven updates to senior leadership and governance forums on CMC status, risks, and execution options
  • Co-lead CMC team meetings and governance forums, applying strong meeting management practices to enable timely decision-making and follow-through
  • Promote a culture of ownership, accountability, and continuous improvement across CMC project teams

QUALIFICATIONS
  • Bachelor's, Master's, or Ph.D. in life sciences or a related discipline, or equivalent industry experience
  • Minimum of 6 years of biopharmaceutical industry experience; experience supporting late-stage or commercial programs strongly preferred
  • At least 2 years of project management experience or demonstrated success leading cross-functional teams in a fast-paced biotech or pharmaceutical environment
  • Proven ability to manage complex, cross-functional programs, identify and mitigate risk, and drive execution in a matrixed organization
  • Strong working knowledge of CMC development, manufacturing, and quality concepts; cell and gene therapy experience is a strong plus
  • Proficiency with project management and collaboration tools, including Microsoft Project, PowerPoint, Excel, and OneNote
  • Strong organizational skills with the ability to manage multiple priorities and shifting timelines
  • Demonstrated ability to translate complex technical plans into clear, actionable communication for technical and non-technical stakeholders


Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency

$136,000-$179,000 USD

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