Pharma Manufacturing Operations Lead

Katecho LLC; Des Moines (IA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, Vision, STD, LTD, and

401(k) Retirement Plan

PTO and paid holidays

Job summary

Surmasis Pharmaceutical seeks a Manufacturing Manager to oversee contract manufacturing activities, providing technical leadership in production, process validation and quality systems within a cGMP environment.

You will manage engineers and operators, coordinate product launches, post-approval changes and routine manufacturing, while ensuring adherence to quality standards and regulatory requirements.

Qualifications

• BS degree in engineering or scientific field with at least five years of experience.
• Minimum five years of pharmaceutical or related industry experience, including late-stage development, process validation and commercial cGMP manufacturing environments.
• Prior experience working at a contract manufacturing organization is a plus.

Responsibilities

• Manages and oversees new product launch, post-approval changes and routine commercial manufacturing activities.
• Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.
• Trains and manages the clean room personnel on relevant production processes and quality systems related to 21 CFR 210/211 and Part 820.
• Technical leadership of Surmasis products with emphasis in equipment management, process, and manufacturing activities.
• Manages team of manufacturing operators and manufacturing technicians.
• Provides senior management visibility of manufacturing floor concerns related to process, product, personnel, procedure, and production performance.
• Assists Engineering department with writing/reviewing batch records and protocols for manufacturing of drug products.
• Writes /reviews development and validation technical reports.
• Works with Quality to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
• First level of escalation for real time technical decisions in line with regulations and Surmasis procedures.
• Ensures that products manufactured for Surmasis adhere to quality standards.
• Performs the department review and approval of GMP documentation (Batch Records, Deviations, Validation Plans, Protocols/Reports, SOPs, CAPAs).
• Escalates quality issues to management for resolution and maintain flow of products and documents to meet site objectives.
• Supports the development and execution of policies, procedures, standards, and guidelines related to technical areas (Production, Validation, New Formulation Introduction, Root Cause Analysis, Process Trending, Risk Assessment).
• Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure.
• Collaborates in data analysis and report creation on metrics and KPIs.
• Regular and reliable attendance is essential for efficient operations.

Education

BS degree in engineering or scientific field

Job description

Surmasis Pharmaceutical seeks a Manufacturing Manager to oversee contract manufacturing activities, providing technical leadership in production, process validation and quality systems within a cGMP environment.

You will manage engineers and operators, coordinate product launches, post-approval changes and routine manufacturing, while ensuring adherence to quality standards and regulatory requirements.