cGMP Consulting Inc.
About Us
At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.
Position Summary cGMP Consulting is seeking a motivated and detail-oriented individual to lead multiple product transfers to Third Party Manufacturer (TPM). This individual will be responsible for overseeing the handover of a product's manufacturing and packaging process between the site and client. This senior-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.
The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and project completion while demonstrating independence. This candidate should have a strong understanding of product transfers, packaging, current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.
Responsibilities
Provide strategic direction for the program, ensuring alignment with business objectives and lifecycle management
Lead and coordinate high-performing, cross-functional teams; including Quality, Regulatory, Manufacturing and Process Engineers
Serve as liaison between internal and external teams, clarifying requirements, timelines, and handoff deliverables
Track and report project milestones and key metrics to stakeholder, enduring transparency and alignment
Facilitate meetings with TPM counterparts to address challenges, resolve issues, and ensure project objectives are met
Oversee documentation transfer, verification and alignment of processes, ensuring all Regulatory, Quality and compliance standards are met during the transition
Mitigate risks, resolve issues and develop contingency plans to keep deliverables on track
Perform additional tasks or duties as assigned by management
Requirements
Bachelor’s degree in Engineering, Science, or a related field of study
3-5 years’ experience in a GMP manufacturing environment, including project management. Must be familiar with regulatory (FDA) requirements
Expertise in one or more of the following areas: validation, qualification of aseptic filling or formulation equipment/processes, qualification of component preparation equipment/processes, and packaging
Advanced critical thinking and technical writing skills
Strong organizational, communication, and interpersonal skills
Compensation and Benefits
Expected pay range per year: $95,000-$125,000 USD
Expected benefits include: Medical, Dental, Vision, PTO, 401K
Disclaimer The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Project Management and Information Technology
Industries Internet Publishing
#J-18808-Ljbffr
Position Summary cGMP Consulting is seeking a motivated and detail-oriented individual to lead multiple product transfers to Third Party Manufacturer (TPM). This individual will be responsible for overseeing the handover of a product's manufacturing and packaging process between the site and client. This senior-level role offers leadership and responsibility in a dynamic, GMP-compliant manufacturing environment.
The ideal candidate will excel in leading cross-functional collaboration, troubleshooting, change management, and project completion while demonstrating independence. This candidate should have a strong understanding of product transfers, packaging, current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.
Responsibilities
Provide strategic direction for the program, ensuring alignment with business objectives and lifecycle management
Lead and coordinate high-performing, cross-functional teams; including Quality, Regulatory, Manufacturing and Process Engineers
Serve as liaison between internal and external teams, clarifying requirements, timelines, and handoff deliverables
Track and report project milestones and key metrics to stakeholder, enduring transparency and alignment
Facilitate meetings with TPM counterparts to address challenges, resolve issues, and ensure project objectives are met
Oversee documentation transfer, verification and alignment of processes, ensuring all Regulatory, Quality and compliance standards are met during the transition
Mitigate risks, resolve issues and develop contingency plans to keep deliverables on track
Perform additional tasks or duties as assigned by management
Requirements
Bachelor’s degree in Engineering, Science, or a related field of study
3-5 years’ experience in a GMP manufacturing environment, including project management. Must be familiar with regulatory (FDA) requirements
Expertise in one or more of the following areas: validation, qualification of aseptic filling or formulation equipment/processes, qualification of component preparation equipment/processes, and packaging
Advanced critical thinking and technical writing skills
Strong organizational, communication, and interpersonal skills
Compensation and Benefits
Expected pay range per year: $95,000-$125,000 USD
Expected benefits include: Medical, Dental, Vision, PTO, 401K
Disclaimer The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Project Management and Information Technology
Industries Internet Publishing
#J-18808-Ljbffr