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Cmc Program Manager Jobs in California (NOW HIRING)

ECHO

Inpatient Nurse Case Manager

Vista, CA · On-site

$33.50 - $45/hr

Case Management is a collaborative process that assesses, plans, implements, coordinates, monitors ... To monitor and participate in the CMC program * To ensure all members are living in the least ...

ECHO

Inpatient Nurse Case Manager

Vista, CA · On-site

$33.50 - $45/hr

Case Management is a collaborative process that assesses, plans, implements, coordinates, monitors ... To monitor and participate in the CMC program * To ensure all members are living in the least ...

Company6405

Inpatient Nurse Case Manager

Vista, CA · On-site

Case Management is a collaborative process that assesses, plans, implements, coordinates, monitors ... To monitor and participate in the CMC program * To ensure all members are living in the least ...

ECHO

Inpatient Nurse Case Manager

Newport Beach, CA · On-site

$33.50 - $45/hr

Case Management is a collaborative process that assesses, plans, implements, coordinates, monitors ... To monitor and participate in the CMC program * To ensure all members are living in the least ...

ECHO

Inpatient Nurse Case Manager

Newport Beach, CA · On-site

$33.50 - $45/hr

Case Management is a collaborative process that assesses, plans, implements, coordinates, monitors ... To monitor and participate in the CMC program * To ensure all members are living in the least ...

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All JobsCmc Program JobsCmc Program Manager JobsCmc Program Manager Jobs in California

Cmc Program Manager information

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 are CMC Program Managers?

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, and why are they important?

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.
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Cmc Program Manager jobs near you
Sr. Program Manager, Client Facing

Sr. Program Manager, Client Facing

Avid Bioservices

Tustin, CA • On-site

$121K - $122K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 7 days ago

Job description

Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Sr. Client Facing CMC Program Manager is a strategic leader responsible for overseeing complex, high value drug substance (DS) CMC programs within a CDMO environment. This role serves as the senior day-to-day partner for external clients, accountable for execution against contractual commitments while shaping delivery strategy, risk posture, and long-term client relationships across early and late phase biologics programs.
As a senior representative of the organization, this role balances client advocacy, operational reality, and enterprise priorities, driving predictable outcomes, trusted partnerships, and sustainable company growth.
Key Responsibilities:
Strategic Client Partnership & Executive Accountability
  • Serve as the senior program lead and primary escalation point for assigned DS CMC client programs
  • Own the overall client relationship post contract, ensuring delivery aligns with scope, timelines, financial commitments, and quality standards
  • Lead executive level client governance, including program reviews, risk discussions, and long-range planning
  • Build credibility as a strategic thought partner, providing forward looking recommendations and scenario-based options
  • Partner closely with Business Development on:
    • Program transitions from pursuit to execution
    • Scope expansion, amendments, and future phase planning
    • Long term account and portfolio strategy

Drug Substance CMC Program Leadership
  • Provide program leadership across end-to-end drug substance CMC activities, including:
    • Process development strategy and lifecycle planning
    • Technology transfer from client or internal development into GMP operations
    • Scale up strategy and manufacturing execution
    • GMP DS manufacturing oversight
    • Process validation, PPQ, and commercialization readiness
  • Define and drive phase appropriate execution strategies:
    • Early phase: flexibility, assumption management, and speed to data
    • Late phase: schedule discipline, risk containment, and supply assurance
  • Ensure integrated execution plans reflect client intent, regulatory strategy, and internal capacity

Cross Functional Leadership & Complex Decision Facilitation
  • Act as the senior integrator across Process Development, Manufacturing, Quality, Supply Chain, Regulatory, and external partners
  • Lead alignment on priorities, resourcing, and tradeoffs for complex or high-risk programs
  • Facilitate critical decision-making forums where quality, schedule, cost, and capacity must be balanced
  • Drive disciplined governance, escalation, and resolution of cross functional conflicts
  • Coach functional and program teams on client centric execution and accountability

Risk, Change & Contract Optimization
  • Own program level risk strategy for technical, operational, regulatory, and schedule exposure
  • Lead proactive mitigation planning and transparent escalation with executive stakeholders and clients
  • Oversee change control for scope, timeline, and cost, ensuring:
    • Clear impact analysis
    • Client alignment and documentation
    • Protection of company and client interests
  • Maintain strong financial awareness, including budget oversight, forecasting, and margin considerations

Portfolio Contribution & Organizational Leadership
  • Contribute to portfolio level prioritization, capacity planning, and governance discussions
  • Serve as a mentor and escalation resource for mid-level CMC program managers
  • Support development and refinement of CDMO CMC program management standards, tools, and best practices
  • Represent Program Management and CMC execution perspectives in internal leadership forums

Minimum Qualifications:
  • Bachelor's degree in a scientific or engineering discipline (advanced degree preferred)
  • 7-10+ years of experience in biotechnology or pharmaceutical CMC program or project management
  • Demonstrated leadership of drug substance CMC programs across development phases
  • Experience operating in a CDMO or client service delivery model with external accountability
  • Strong understanding of GMP manufacturing, validation, regulatory expectations, and commercialization readiness
  • Proven ability to influence senior client and internal stakeholders
  • Advanced proficiency with scheduling and program management tools (e.g., Smartsheet, MS Project)

Position Type/Expected Hours of Work:
This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $153,600 - $192,000annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
  • A confident senior leader comfortable representing the organization with external clients
  • Skilled at navigating ambiguity, tradeoffs, and high stakes decision making to drive program results
  • Strategic, solutions-oriented, and commercially aware
  • Able to mentor others while maintaining hands on accountability where needed
  • Motivated by building trusted partnerships and delivering consistent, high-quality outcomes

Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
ID:627

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