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 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 environment. Must 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: $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.
Top Skills
What We Do
Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.
