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Cmc Program Manager Jobs in Minnesota (NOW HIRING)

GMP Data Reviewer (Pharma)

Oakdale, MN

$55K - $65K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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

PLS Associate Scientist II

Oakdale, MN · On-site

$25 - $27/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... management, and functional leaders regarding chemistry/biochemistry policies, programs, and ...

PLS Associate Scientist II

Oakdale, MN

$25 - $27/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... management, and functional leaders regarding chemistry/biochemistry policies, programs, and ...

PLS GMP Data Reviewer (Pharma)

Oakdale, MN

$55K - $65K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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

New

GMP Data Reviewer (Pharma)

Oakdale, MN

$55K - $65K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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

PLS QA Document Control Specialist

Oakdale, MN

$21 - $24/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... SUMMARY Responsible for performing and managing QA administrative and document control tasks while ...

PLS QA Document Control Specialist

Oakdale, MN · On-site

$21 - $24/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Pace ® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... SUMMARY Responsible for performing and managing QA administrative and document control tasks while ...

PLS Scientist III

Oakdale, MN · On-site

$85K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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 ...

Showing results 21-31

Cmc Program Manager information

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 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:

$55K - $65K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 days ago


Job description

Shift:

Monday through Friday, 8:30 AM - 5:00 PM

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

This is a full-time, onsite, GMP Data Reviewer position located in Oakdale, MN, Monday through Friday, 8:30 a.m. - 5:00 p.m.

Compensation: $55,000 - $65,000 per year

The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate’s geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer. 

Make an Impact. Build a Career.

Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization.

Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

ESSENTIAL FUNCTIONS 

This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and 

skills. 

  • Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information.  This includes, but is not limited to manufacturing batch records, technical records, pertinent laboratory or quality control data, standard operating procedures (SOPs), quality exceptions, logbooks, tracking systems and LIMS data/reports. Data and records may be in the form of electronic or paper records or laboratory notebooks. 

  • Provides intermediate to complex analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; involves varied operations and leading implementation and change. 

  • Provides various research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required. 

  • Analyzes and reviews intermediate to complex operations, results, feedback, and related quality information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management. 

  • Ensures the accuracy of various tests, equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies. 

  • Assists with developing or participating in quality or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management. 

  • Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed. 

  • Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. 

  • Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.  

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. 

Education and Experience 

Bachelor's degree in chemistry, operations, or a closely related field; AND two to four (2-4) years of quality experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience. 

Required Knowledge and Skills 

Required Knowledge 

  • Intermediate to complex principles, practices, and techniques of quality. 

  • Various understanding of the administration and oversight of quality programs, policies, and procedures. 

  • Intermediate to complex methods to resolve quality problems, questions, and concerns. 

  • Various understanding of applicable quality laws, codes, and regulations. 

  • Understanding of various testing tools, equipment, and calibration. 

  • Computer applications and systems related to the work. 

  • Principles and practices to serving as an effective project team member. 

  • Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations. 

  • Correct business English, including spelling, grammar, and punctuation. 

Required Skills 

  • Performing intermediate to complex professional-level quality duties in a variety of assigned areas. 

  • Overseeing and administering comprehensive and varied quality functions. 

  • Training others in policies and procedures related to the work. 

  • Serving as a team member and the development and management of projects. 

  • Operating in a both a team and individual contributor environment. 

  • Interpreting, applying, and explaining applicable laws, codes, and regulations. 

  • Preparing intermediate to complex functionals reports, correspondence, and other written materials. 

  • Using initiative and independent judgment within established department guidelines. 

  • Using tact, discretion, and prudence in working with those contacted in the course of the work. 

  • Performing effective oral presentations to large and small groups across functional peers and the department. 

  • Contributing effectively to the accomplishment of team or work unit goals, objectives and activities. 

  • Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work. 

PHYSICAL/MENTAL REQUIREMENTS 

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

 

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.   

WORKING ENVIRONMENT 

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors and related items in a lab setting.  

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.