Product Transfer Project Manager

North Chicago, IL - USA

Yearly Salary: USD 75000 - 95000

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

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 products 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 understand of product transfers packaging current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.

Responsibilities

The essential functions include but are not limited to the following:

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

Bachelors degree in Engineering Science or a related field of study.
3-5 years experience in a GMP manufacturing environment including project 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: $95000-$125000 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.

Required Experience:

About UsAt 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 pharmace...