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Associate Cmc Project Manager Jobs (NOW HIRING)

CMC Project Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Primary Function of Position The CMC Project Manager serves as a strategic and operational partner to Chemistry, Manufacturing, and Controls (CMC) leadership, providing integrated project management ...

Primary Function of Position The CMC Project Manager serves as a strategic and operational partner to Chemistry, Manufacturing, and Controls (CMC) leadership, providing integrated project management ...

Primary Function of Position The CMC Project Manager serves as a strategic and operational partner to Chemistry, Manufacturing, and Controls (CMC) leadership, providing integrated project management ...

CMC Project Leader

Cambridge, MA ยท On-site

$140K - $190K/yr

Job Title Associate Director / Senior Manager, CMC Project Management Location Boston area preferred (or ability to commute regularly) Company Overview Hongene Biotech is a global leader in nucleic ...

CMC Project Leader

Cambridge, MA ยท On-site

$140K - $190K/yr

Job Title Associate Director / Senior Manager, CMC Project Management Location Boston area preferred (or ability to commute regularly) Company Overview Hongene Biotech is a global leader in nucleic ...

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Associate Cmc Project Manager information

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How much do associate cmc project manager jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for associate cmc project manager in the United States is $38.75, according to ZipRecruiter salary data. Most workers in this role earn between $29.81 and $44.95 per hour, depending on experience, location, and employer.

What is an Associate CMC Project Manager?

An Associate CMC (Chemistry, Manufacturing, and Controls) Project Manager is a professional who coordinates and oversees the various activities involved in the development, manufacturing, and regulatory submission of pharmaceutical products. They work with cross-functional teams to ensure that CMC-related milestones are met on time and in compliance with regulatory standards. Their responsibilities often include project planning, timeline management, documentation, and facilitating communication between departments such as research, development, quality, and regulatory affairs. This role is crucial in ensuring that pharmaceutical products are developed efficiently and brought to market safely.

What are the key skills and qualifications needed to thrive as an Associate CMC Project Manager?

To thrive as an Associate CMC Project Manager, you need a solid understanding of chemistry, manufacturing, and controls (CMC) processes, often supported by a degree in life sciences or engineering and project management experience. Familiarity with project management tools like MS Project, regulatory submission systems, and quality management software is typically required. Strong organizational, communication, and cross-functional collaboration skills help drive project success and facilitate teamwork among diverse stakeholders. These skills ensure effective coordination, timely project delivery, and compliance with regulatory standards in pharmaceutical development.

What are some common challenges faced by Associate CMC Project Managers in coordinating cross-functional teams?

Associate CMC Project Managers often navigate the complexities of aligning priorities and timelines across diverse teams such as analytical, manufacturing, regulatory, and quality assurance. One common challenge is ensuring clear and consistent communication among stakeholders with varying technical backgrounds and objectives. Additionally, managing shifting project timelines due to unforeseen technical issues or regulatory changes requires adaptability and proactive problem-solving. Successful Associate CMC Project Managers foster collaboration, anticipate potential bottlenecks, and implement structured project tracking to keep deliverables on schedule.

What are popular job titles related to Associate Cmc Project Manager jobs?

For Associate Cmc Project Manager jobs, the most frequently searched job titles are:

Associate/Sr. Associate - CMC Project Management & Operations

Waltham, MA โ€ข On-site

Full-time

Re-posted 6 days ago


Job description

About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Associate/Sr. Associate - CMC Project Management and OperationsLocation: Waltham, MA Hybrid - onsite 3 days/week required
Reports to: CMC Program Manager
Position Overview:We are seeking a highly motivated Associate/Sr. Associate to join our dynamic growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal in developing and managing systems to support critical CMC projects, driving the success of our clinical stage programs. This role reports to the CMC Program Manager.
The ideal candidate will have strong written and verbal communication skills and enjoy working with cross-functional teams and stakeholders. They should be highly organized, able to manage multiple priorities, and comfortable working in a fast-paced environment. Some experience in drug development, manufacturing, CMC, or a related scientific field is preferred. The successful candidate will be proactive, detail-oriented, and eager to learn and contribute across a range of activities.
Our team values in-person collaboration, and we expect this role to work from our Waltham office three days per week. We're looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.
Key Responsibilities
  • Support CMC program execution by assisting the CMC Program Manager with day-to-day coordination of late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities.
  • Manage CMC documentation workflows, including drafting support, formatting, version control, review routing, comment resolution tracking, approvals, and archival of key program documents.
  • Maintain integrated CMC trackers and timelines for deliverables such as batch records, protocols, reports, specifications, comparability documentation, stability updates, regulatory content, and manufacturing readiness milestones.
  • Prepare meeting materials and outputs, including agendas, decision logs, action-item trackers, meeting minutes, dashboards, and follow-up communications for CMC team meetings and governance reviews.
  • Track risks, issues, decisions, and dependencies across CMC workstreams and escalate delays, gaps, or cross-functional misalignments to the CMC Program Manager.
  • Support external partner and CDMO coordination by managing document exchanges, action trackers, meeting follow-ups, deliverable status updates, and communication records.
  • Contribute to continuous improvement of CMC project management tools and processes, including templates, trackers, document control practices, reporting formats, and readiness checklists.

Qualifications:
  • Master's degree in life sciences, engineering, pharmaceutical sciences, biotechnology or a related discipline with 0-2 years relevant experience, or Bachelor's degree with 2-4 years of relevant experience.
  • Experience in a biopharmaceutical, biotechnology, or regulated drug development environment is required.
  • Experience in manufacturing, drug development, process development, analytical or other CMC-related functions is preferred.
  • Strong organizational skills with the ability to manage multiple priorities, track deliverables, maintain timelines, and follow up on action items.
  • Excellent written and oral communication skills, with the ability to prepare clear meeting summaries, trackers and cross-functional messages.
  • Ability to work independently while knowing when to escalate risks, issues or delays.
  • Proficiency with standard business and project-management tools, such as Microsoft Office, Sharepoint, Smartsheet or similar systems.
  • Ability to operate in a fast-paced, timeline-driven environment and adapt to changing program priorities.
  • Basic understanding of regulated documentation practices, GMP concepts or CMC development workflows is preferred.

Compensation:
  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range for candidates in Waltham, MA for Associate level is $104,000 - $125,000 and for Sr. Associate is $130,000 - $146,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.

Location: Waltham, MA Hybrid - onsite 3 days/week required
Salary Range for the Role
$104,000-$146,000 USD
What We Offer:
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
  • Competitive salary and benefits package.
  • A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
  • Opportunities for professional growth and development.