NPI Project Manager

North Chicago, IL - USA

Yearly Salary: USD 75000 - 95000

Posted on: Yesterday

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:

Lead all aspects of NPI projects from strategic decisions stakeholder management scheduling team meetings budget communications and supplier / customer mangagment.
Responsible for providing technical input leading to shape the overall strategies for the front-end planning due diligence and technical feasibility assessments for potential New Product Introductions.
Set and lead NPI site program strategy including stage and gate meetings timelines to meet program objectives.
Work with Site Senior Management in the development and execution of the project development plan and governance body deliverables. Lead Governance Board Meetings.
Develop and assess cost and resource projections for potential new business development opportunities and serve as point of contact.
Ensure consistency and compliance across all aspects of NPI programs.
Effective NIP projects oversight to ensure on time delivery of project(s) deliverables.
Perform additional tasks or duties as assigned by management.

Requirements

Bachelors degree in Engineering Science or a related field of study.
4 years experience in a GMP manufacturing be familiar with regulatory (FDA) requirements.
Expertise in technical transfer and new product launch within Pharmaceutical Manufacture environment.
Strong knowledge in drug development process and pharmaceutical manufacturing process.
Advanced critical thinking and technical writing skills.
Strong organizational communication and interpersonal skills.

Compensation and Benefits

Expected pay range per year: $950000-$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...