Pharma Manufacturing Manager — cGMP & Quality Leader

Katecho, LLC; Des Moines, Northern (IA, KY); Hybrid; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

STD

LTD

Life Insurance

401(k)

PTO

Paid holidays

Job summary

Surmasis Pharmaceutical is seeking a Manufacturing Manager to oversee contract manufacturing activities, providing technical leadership in pharmaceutical processes, manufacturing and packaging for commercial products in a cGMP environment.

The role involves coordinating launches, post-approval changes, batch record reviews, and quality system implementation, while working with quality, engineering, and other support teams to resolve issues and ensure product quality.

Qualifications

• BS degree in engineering or science with 5+ years in operations/engineering.
• Minimum 5 years in pharmaceutical or related industry including cGMP manufacturing.
• Experience with contract manufacturing organizations preferred.

Responsibilities

• Oversee new product launches, post-approval changes, and routine manufacturing.
• Plan product needs and coordinate manufacturing schedules.
• Train clean room personnel on processes and 21 CFR 210/211 and 820.
• Provide technical leadership in equipment, process, and manufacturing activities.
• Manage manufacturing operators and technicians.
• Ensure compliance with quality standards and regulatory requirements.
• Collaborate with Engineering to write batch records and protocols.

Skills

Leadership

Quality systems

Regulatory compliance

Process optimization

Cross-functional collaboration

Education

BS degree in Engineering or Science

Job description

Surmasis Pharmaceutical is seeking a Manufacturing Manager to oversee contract manufacturing activities, providing technical leadership in pharmaceutical processes, manufacturing and packaging for commercial products in a cGMP environment.

The role involves coordinating launches, post-approval changes, batch record reviews, and quality system implementation, while working with quality, engineering, and other support teams to resolve issues and ensure product quality.