1

Cmc Program Manager Jobs in Michigan (NOW HIRING)

Deputy City Clerk

Southfield, MI · On-site

$84K - $127K/yr

Manage document retention in accordance with applicable regulations * Update and maintain the ... MiPMC (Michigan Professional Municipal Clerk) and CMC (Certified Municipal Clerk) designations are ...

Financial Counselor

Grand Rapids, MI · On-site

$18.25 - $23.75/hr

The Financial Counselor works closely with clinical providers (i.e. physicians, case managers ... CRT-Application Counselor (CAC) - CMC Centers for Medicare & Medicaid Services 60 Days About ...

next page

Showing results 1-20

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.
What are popular job titles related to Cmc Program Manager jobs in Michigan? For Cmc Program Manager jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in Michigan look for? The top searched job categories for Cmc Program Manager jobs in Michigan are:
What cities in Michigan are hiring for Cmc Program Manager jobs? Cities in Michigan with the most Cmc Program Manager job openings:
Project Manager

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 17 days ago


Job description

Project Manager

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position: 

The Project Manager is responsible for leading technology transfer projects for new products being introduced into GRAM manufacturing facilities, as well as managing ongoing Commercial Supply and Life Cycle Management (LCM) projects. This role serves as the primary liaison between customers and cross-functional internal teams, overseeing all phases of project execution from initiation through closure. 

Key responsibilities include developing and maintaining project schedules, defining scope, tracking milestones, managing risks, assigning responsibilities and action items, monitoring critical path activities, and ensuring timely resolution or escalation of issues. The Project Manager is responsible for authoring project work orders/change orders, and other project documentation while maintaining accurate and up to date project data in SmartSheet. The role requires strong organizational, communication, and relationship-management skills. This is a fully onsite position requiring flexibility to support customer visits and a dynamic project environment.

Non-Negotiable Requirements:

  • Bachelor’s degree in Project Management, Biochemistry, Biomedical Engineering or other Life Sciences or related field, and a minimum of 4 years related work experience in Pharma/Biotech/Life Sciences or similarly regulated industry.
  • Proficient in project management software required.
  • Training or education in project management or equivalent knowledge and experience.
  • Knowledge of project management techniques and tools.
  • Experience in a pharmaceutical manufacturing, laboratory, or CMC regulatory environment.
  • Regulatory knowledge of pharmaceutical manufacturing with GMPs, change control, risk management and quality by design.

Preferred Requirements:

  • Direct work experience in project management capacity, specifically with tech transfer of products into a sterile manufacturing facility.
  • Customer facing experience in pharmaceutical environment.
  • PMP Certification desired.

Responsibilities Include (but are not limited to):

  • Lead end-to-end project management for technology transfer, commercial supply, and lifecycle management (LCM) projects. 
  • Serve as the primary liaison between customers and cross-functional internal teams. 
  • Define project scope, milestones, deliverables, timelines, risks, and success criteria. 
  • Manage change controls, tech transfer plans, and project documentation. 
  • Oversee execution of commercial supply agreements and ensure contractual commitments are met. 
  • Coordinate resources and deliverables across multiple departments. 
  • Facilitate project meetings, agendas, action items, and meeting minutes. 
  • Drive risk identification, mitigation planning, issue resolution, and escalation. 
  • Provide regular project updates to customers and senior leadership. 
  • Build strong client relationships, manage expectations, and improve customer satisfaction. 
  • Support customer visits and maintain flexibility in a dynamic environment.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!