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Cmc Program Manager Jobs in Minnesota (NOW HIRING)

Director, Regulatory Affairs

Minneapolis, MN · On-site

$156.60K - $206.70K/yr

... manage regulatory risk across the product lifecycle. Responsibilities include preparation for and ... programs, aligned with development, CMC, and commercial objectives. * Provide guidance and ...

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... programs from early development through commercialization. Our experienced industry experts and ...

PLS Senior Project Manager

Oakdale, MN · On-site

$70K - $80K/yr

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... programs from early development through commercialization. Our experienced industry experts and ...

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... staff, management, and functional leaders regarding quality policies, programs, and practices ...

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... staff, management, and functional leaders regarding quality policies, programs, and practices ...

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... Provides analytical insight and recommendations to management and project teams regarding ...

PLS Scientist I

Oakdale, MN · On-site

$60K - $70K/yr

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... Provides analytical insight and recommendations to management and project teams regarding raw ...

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... Ability to manage multiple projects concurrently and meet deadlines. * Proficiency in Microsoft ...

PLS Scientist III

Oakdale, MN · On-site

$85K - $95K/yr

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... Ability to manage multiple projects concurrently and meet deadlines. * Proficiency in Microsoft ...

Cmc Program Manager information

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 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 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 popular job titles related to Cmc Program Manager jobs in Minnesota? For Cmc Program Manager jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in Minnesota look for? The top searched job categories for Cmc Program Manager jobs in Minnesota are:
Product Complaint Manager

Product Complaint Manager

Boston Scientific

Arden Hills, MN • Hybrid

Full-time

Posted 27 days ago


Boston Scientific rating

8.4

Company rating: 8.4 out of 10

Based on 117 frontline employees who took The Breakroom Quiz

48th of 515 rated manufacturers


Job description

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

Everyone at Boston Scientific works toward one goal: transforming lives by tackling some of the most critical challenges in the medical device industry. Patient care is at the heart of everything we do, and ensuring quality, compliance, and patient outcomes are essential to delivering on that commitment.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

As a Product Complaint Manager, you will lead complaint handling and post-market surveillance activities within the Electrophysiology Complaint Management Center (EP CMC), partnering with the EP CMC leadership team and cross-functional partners to ensure a compliant and high-performing complaint handling program that supports patient safety and product quality.

You will drive operational excellence, oversee the assessment and escalation of product issues, and support risk management activities to ensure patient safety and regulatory compliance. This role is key to advancing continuous improvement, maintaining audit and inspection readiness, and ensuring alignment with evolving regulatory requirements.

Work model, sponsorship, relocation:

• At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Lead and develop a high-performing team responsible for daily complaint handling operations, providing direction to supervisors and staff while driving performance, engagement, and team development.

• Assess resource needs, support hiring and onboarding activities, and build organizational capability through training and professional development.

• Ensure complaints are reviewed, investigated, and documented in accordance with corporate policies and global regulatory requirements, including FDA and international regulatory authorities.

• Maintain accurate, complete, and compliant complaint records within the Global Complaint Management Database.

• Identify and implement process, system, and workflow improvements to enhance efficiency, quality, and compliance.

• Oversee third-party and off-site teams to ensure adherence to quality and regulatory standards.

• Lead structured problem-solving activities and manage escalation of adverse trends, product issues, and operational risks.

• Support internal and external audits and inspections and maintain ongoing team readiness through training and compliance activities.

Qualifications:

Required qualifications:

• Bachelor’s degree in a scientific, engineering, or technical discipline.

• Minimum of 7 years' experience in the medical device industry.

• Minimum of 3 years' experience in a leadership role within the medical device industry.

Preferred qualifications:

• Demonstrated leadership skills, including team development, performance management, and effective communication.

• Knowledge of U.S. and international regulatory reporting requirements, including FDA and global vigilance requirements.

• Experience supporting post-market quality activities, including complaint handling and vigilance.

• Experience interacting with regulatory authorities or Competent Authorities.

• Experience supporting audits or inspections, including front-room and back-room activities.

• Project management experience with the ability to drive initiatives to completion.

• Experience managing external partners or vendors.

Requisition ID: 629886 

Minimum Salary: $ 102100 

Maximum Salary: $ 194000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  


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