Cmc Program Manager Jobs in Minnesota (NOW HIRING)

Shift:

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, Senior Scientist / Scientist 3 position located in Oakdale, MN, Monday through Friday, 8:30 a.m. - 5:00 p.m.

The Scientist III / Senior Scientist will lead the design, optimization, and validation of analytical methods that support product development, regulatory submissions, and commercial readiness for biopharmaceuticals in a GMP environment.

Job Responsibilities:

• Lead the development, optimization, and qualification/validation of analytical methods for biopharmaceutical drug substances and drug products, including peptides, oligos, proteins, mAbs, etc.

• Serve as a technical expert for bioanalytical techniques, specifically ELISA, plate-based assays, SDS-PAGE, cell-based assays, qPCR, ddPCR, Sanger Sequencing, CE, cIEF, and similar.

• Design scientifically sound method development strategies aligned with ICH Q2(R2) and evolving regulatory expectations for biologics. Stay current with evolving regulatory expectations (ICH, USP, EP) and implement best practices.

• Author and review method development reports, validation protocols, validation reports, and laboratory methods.

• Provide scientific leadership during investigations, troubleshooting, and method lifecycle management.

• Mentor and train junior scientists and contribute to building a culture of scientific excellence and continuous improvement.

• Present data to and collaborate with client organizations.

Job Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 8-10 years of relevant laboratory experience.

• Master’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 4-7 years of relevant laboratory experience.

• Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 1-4 years of relevant laboratory experience.

• Demonstrated expertise in bioanalytical method development and validation for biologics.

• Strong hands-on experience with key biopharmaceutical analytical platforms

• Familiarity with GMP, ICH guidelines, and regulatory expectations for biologics

• Excellent technical writing skills and experience

• Strong communication, leadership, and project management capabilities.

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.

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 accommodation 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 and sample 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.