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Cmc Program Manager Jobs in Colorado (NOW HIRING)

Novo Nordisk

Senior Quality Control Specialist

Boulder, CO · On-site

$127K - $155K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development ... The Position The Senior QC Specialist will assist with management and oversight of QC testing and ...

Novo Nordisk

Senior Quality Control Specialist

Boulder, CO · On-site

$127K - $155K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development ... The Position The Senior QC Specialist will assist with management and oversight of QC testing and ...

Colorado Mountain College

Adjunct Faculty, Art

Rifle, CO · On-site

CMC does not conduct research but instead focuses on excellence in teaching and learning in diverse ... Example for business: (business, finance, management, marketing, or related fields). Minimum of one ...

Colorado Mountain College

Adjunct Faculty, GED

Rifle, CO · On-site

CMC does not conduct research but instead focuses on excellence in teaching and learning in diverse ... Example for business: (business, finance, management, marketing, or related fields). Minimum of one ...

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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 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 are popular job titles related to Cmc Program Manager jobs in Colorado?

For Cmc Program Manager jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Cmc Program Manager jobs in Colorado look for?

The top searched job categories for Cmc Program Manager jobs in Colorado are:

What cities in Colorado are hiring for Cmc Program Manager jobs?

Cities in Colorado with the most Cmc Program Manager job openings:

Cmc Program Manager jobs near you
Infographic showing various Cmc Program Manager job openings in Colorado as of August 2026, with employment types broken down into 75% Full Time, and 25% Part Time. Highlights an 100% In-person job distribution.

Senior Quality Control Specialist

Novo Nordisk

Boulder, CO • On-site

$127K - $155K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Novo Nordisk rating

8.2

Company rating: 8.2 out of 10

Based on 58 frontline employees who took The Breakroom Quiz

32nd of 86 rated pharmaceutical

Job description

About the Department
The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference.
The Position
The Senior QC Specialist will assist with management and oversight of QC testing and reporting performed at Contracted Manufacturing and Testing Organizations. This includes testing and ongoing stability of unique API starting materials, Drug Substance and Drug Product. Assist in all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides QC support to the Development, CMC, Operations, QA/QC and Regulatory Affairs departments.
Relationships
Reports to Quality Control Manager.
Essential Functions
  • Demonstrate technical proficiency in analytical methodology and ensure quality control activities are carried out according to and with adherence to regulatory and internal requirements, cGMP and ICH compliance
  • Create, revise, review and approve protocols, supporting analytical data and reports associated with method validation, testing and release of GMP starting materials, intermediates, Drug Substances and Drug Products
  • Serve as QC lead on analytical project teams and product operational teams
  • Conduct or support investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results
  • Write/revise SOPs, technical protocols, change control and other quality related reports
  • Work with the Quality management team to continuously improve the quality, compliance and efficiency of QC operations
  • Effectively communicate internal issues related to performance, processes and procedures
  • Be a self-starting problem solver who drives results through high compliance and a positive work style

Qualifications
  • BS/BA in science related field or equivalent experience with 4+ years of related Quality Control experience in biotech or pharmaceutical position, particularly in a GMP environment
  • Ability to perform analytical methods, interpret and trend stability data including, but not limited to: Chromatography (IP-RP-UPLC/ SAX-HPLC/ GC) Mass Spec, FTIR, metals testing, residual solvents, vapor pressure and freezing point osmolality, UV, pH, endotoxin, sterility and bioburden
  • Knowledge of FDA cGMP regulations, ICH and FDA Guidances for Industry, Compendial requirements, other-country regulations and standards
  • Expertise in data analysis including reviewing, reporting and trending data.
  • Strong problem solving/analytical skills
  • The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
  • Excellent written and verbal communication skills, strong negotiation and decision-making skills and attention to detail are equally important
  • Strong organizational skills, with the ability to handle multiple tasks in a fast-paced environment

The base compensation range for this position is $127,500 to $155,400. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.
The job posting is anticipated to close on August 6, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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