Pharma Process Implementation Lead

Corden Pharma Boulder, Inc.; Boulder (CO); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Paid Parental Leave

Wellness Program

Job summary

CordenPharma Boulder is seeking a Manufacturing Process Specialist to lead cross-functional teams across Manufacturing, R&D, and Regulatory groups for API production in Colorado. The role focuses on startup activities, process optimization, and compliance with GMP standards.

Ideal candidates will have a BS in Chemical or Pharmaceutical Manufacturing and 5+ years of related experience, with strong skills in P&ID, change control, and regulatory documentation.

Qualifications

• Bachelor's degree in chemical or pharmaceutical manufacturing with GMP experience preferred.
• 5 years related experience or equivalent combination.
• Ability to read and interpret procedures and regulations.

Responsibilities

• Establish and maintain cross-functional relationships across manufacturing, R&D, and regulatory groups.
• Execute startup activities for chemical processes to meet schedule.
• Prepare change control documents and ensure timely documentation.
• Participate in PHAs and implement CAPAs.

Skills

Leadership

Problem solving

Regulatory compliance

LEAN principles

Education

Bachelor's degree in Chemical or Pharmaceutical Manufacturing

Tools

P&ID knowledge

Change control procedures

Job description

CordenPharma Boulder is seeking a Manufacturing Process Specialist to lead cross-functional teams across Manufacturing, R&D, and Regulatory groups for API production in Colorado. The role focuses on startup activities, process optimization, and compliance with GMP standards.

Ideal candidates will have a BS in Chemical or Pharmaceutical Manufacturing and 5+ years of related experience, with strong skills in P&ID, change control, and regulatory documentation.