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Cmc Program Manager Jobs in Irvine, CA (NOW HIRING)

Develops and manages content strategy for regulatory submissions, including INDs/CTAs and ... This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is ...

Develops and manages content strategy for regulatory submissions, including INDs/CTAs and ... This job is eligible to participate in our long-term incentive programs. โ€‹ Note: No amount of pay ...

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Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Be Seen First

Build, manage, and grow a book of business within an assigned local territory * Prospect new ... Participate in ongoing training sessions, team meetings, and leadership development programs ...

Reporting to the Senior Director of Program Management, this role will support and gradually take ... Coordinates with Clinical, Regulatory, CMC, and other functions to ensure alignment on timelines ...

R&D Project Manager

Irvine, CA ยท On-site

$95K - $110K/yr

Reporting to the Senior Director of Program Management, this role will support and gradually take ... Coordinates with Clinical, Regulatory, CMC, and other functions to ensure alignment on timelines ...

Reporting to the Senior Director of Program Management, this role will support and gradually take ... Coordinates with Clinical, Regulatory, CMC, and other functions to ensure alignment on timelines ...

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Cmc Program Manager information

See Irvine, CA salary details

$41.3K

$115.3K

$168.5K

How much do cmc program manager jobs pay per year?

As of Aug 22, 2026, the average yearly pay for cmc program manager in Irvine, CA is $115,347.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,300.00 and $142,200.00 per year, depending on experience, location, and employer.

What is a CMC Program Manager?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What are the key skills and qualifications needed to thrive as a CMC Program Manager?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What job categories do people searching Cmc Program Manager jobs in Irvine, CA look for?

The top searched job categories for Cmc Program Manager jobs in Irvine, CA are:

What cities near Irvine, CA are hiring for Cmc Program Manager jobs?

Cities near Irvine, CA with the most Cmc Program Manager job openings:

Infographic showing various Cmc Program Manager job openings in Irvine, CA as of June 2026, with employment types broken down into 2% As Needed, 89% Full Time, 4% Part Time, and 5% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $115,347 per year, or $55.5 per hour.

Clinical Services Nurse

PHYSICIANS DATA TRUST

Newport Beach, CA โ€ข On-site

$33.50 - $45/hr

Full-time

Posted yesterday

New


Job description

Primary Purpose:

To provide support and facilitate care of members who require case management. To work collaboratively with Health Plan and Hospital Case Management Departments in the facilitation of services. To collaborate with the treating physician and IPA Medical Director in the review and decision-making process regarding the facilitation of appropriate health care and service requests. Case Management is a collaborative process which assesses, plans, implements, coordinates, monitors, and evaluates an individual’s health needs through communication and available resources to promote quality, cost-effective outcomes. If applicable, the CM will coordinate care for Cal Medi-Connect program members to ensure all aspects of the CMC program description are implemented and followed. All services under Medicare and Medi-Cal will be coordinated and monitored, including CCS, IHSS, CBAS, and BH. A case manager is a licensed nurse LVN. A care manager can be a licensed social worker (MSW) or licensed nurse LVN.

All candidates for any position within case management will have the appropriate education and experience to meet requirements and the service needs of the populations.

Principal Duties and Responsibilities (* = essential functions):

· To utilize the Case Management functions: assessor; planner; facilitator; advocate. *

· To facilitate services at the appropriate Health Plan center of excellence. *

· To utilize the most cost-effective case rates and contracts. *

· To review and process clinical information in accordance with regulatory mandates to facilitate patient healthcare and services, across the continuum of care. *

· To perform catastrophic case management as appropriate to the patient’s medical condition and healthcare needs utilizing the standards of practice for Case Management.

· To interface professionally and courteously with all internal staff and external customers to ensure appropriate exchange of information. *

· To prepare and participate in health plan audits onsite as required.

· To actively participate in Utilization Management Committees in regard to Case Presentations and problem solving.

· To participate in the development of Case Management Policies and Procedures.

· To actively participate in the discharge planning process. *

· To monitor and participate in the SNP/Duals program

· To monitor and participate in the CMC program

· To ensure all members are living in the least restrictive environment

· To follow the UM/QI/CM/SNP/CMC program descriptions

· To perform other duties as assigned.

Job Specifications (KSAs):

  • Requires extensive and specialized knowledge of utilization and case management processes as is generally acquired by 2-3 years or greater of experience as a case manager in a Managed Care Environment, and successful completion of a nursing program.
  • Requires prior Case Management experience, preferably with catastrophic cases.
  • Requires an active LVN license in the state of employment.
  • Requires clinical expertise as is generally acquired by 3 to 5 years of acute nursing practice.
  • Requires excellent written and verbal communication skills.
  • Requires computer experience, particularly Microsoft Word, Excel, familiarity with Cozeva a plus, and the ability to learn new software applications quickly.
  • Requires problem-solving and critical thinking skills.
  • Requires professional demeanor and the ability to contribute to a positive work environment.
  • Requires knowledge of regulatory standards such as Medicare, TitleXXII, and Medi-Cal*
  • Requires extensive knowledge of health plan guidelines.

Position Performance Criteria:

1. Demonstrates proficiency in UM and Case Management including but not limited to:

  • Catastrophic Case Management
  • Transplant Management
  • Referral review
  • Out-of-network management
  • Denial letter process
  • Concurrent/inpatient review and bed-day management.

2. Demonstrates the effective practice of Case Management Standards of Care including:

  • Assessment
  • Case Identification and Selection
  • Planning
  • Monitoring
  • Evaluating
  • Outcomes

3. Sets appropriate priorities to meet departmental goals and objectives including but not limited to:

  • Demonstrates ability to efficiently manage case load.
  • Demonstrates ability to set appropriate priorities
  • Consistently renders prudent and sound decisions
  • Manages multiple tasks while meeting required timeframes
  • Adheres to departmental policies and procedures

4. Demonstrates knowledge of Health Plan guidelines.

5. Demonstrates knowledge of federal, state, NCQA, and health plan regulatory requirements and approved criteria guidelines.

  • Ensures consistency in the application of the utilization process.
  • Maintains knowledge of new legislation and disseminates information to providers and co-workers.

4. Demonstrates ability to give concise, articulate and accurate case presentations to Medical Director, UMC, etc including problem solving.

5. Demonstrates cost savings.

6. Consistently demonstrates professional work ethic, collegial interaction with others, and reliability, while contributing to a positive work environment, including but not limited to:

· Professional appearance and demeanor

· Meets departmental attendance needs on site

· Participates verbally in group activities, i.e. staff meetings, etc.

· Demonstrates respect to co-workers and customers.

· Works collaboratively with other departments to identify and resolve issues.