Manager, Aseptic Process Operations
Kindeva Drug Delivery, Des Moines, IA, United States
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. We are driven by our mission to serve as a world-class, global CDMO that enables the next generation of medicines through excellence in drug delivery.
Role Responsibilities
Provide operational coverage and expertise across all manufacturing areas: formulation, clean and prep, filling, sanitization, material handling, and warehouse.
Serve as a SME and mentor for manufacturing processes and ERP-related tasks.
Act as the site expert in ERP system usage, specifically Microsoft Dynamics 365, supporting all users with training, real-time troubleshooting, and transactional oversight to achieve positive outcomes.
Manage all real-time ERP shop floor transactions, focusing on identifying and resolving variances, ensuring accurate material consumption, batch reconciliation, and inventory movements.
Float across areas to support operational gaps, provide temporary leadership coverage, or conduct targeted training and oversight sessions.
Provide support to off-shifts, as needed, particularly regarding ERP transaction resolution and training.
Ensure compliance with cGMP, data integrity, and aseptic processing principles during all job functions and while training others.
Support continuous improvement initiatives and identify opportunities to streamline ERP transactions and manufacturing processes.
Partner with Quality, Operations, and Training departments to ensure proper documentation, training records, and procedural compliance.
Serve as a role model for operational excellence, right-first-time execution, and strong communication.
Perform other related duties as assigned.
Basic Qualifications
Bachelor's degree in science, engineering, or business administration required.
Minimum of 10 years of experience in aseptic pharmaceutical manufacturing or an equivalent combination of education and practical expertise.
Demonstrated experience with ERP systems required; expertise in Microsoft Dynamics 365 strongly preferred.
Financial and operational fluency in manufacturing environments with a focus on variance management and production accuracy.
Subject matter expertise in aseptic manufacturing processes including formulation, clean and prep, sanitization, and filling.
Proven ability to train others in both technical execution and ERP transaction compliance.
Excellent verbal and written communication skills; ability to write and deliver technical training content.
Strong analytical and problem-solving skills, particularly in real-time manufacturing environments.
High degree of organizational skills, attention to detail, and commitment to quality.
Ability to work cross-functionally with production, quality, IT, and warehouse teams.
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer
#J-18808-Ljbffr
Role Responsibilities
Provide operational coverage and expertise across all manufacturing areas: formulation, clean and prep, filling, sanitization, material handling, and warehouse.
Serve as a SME and mentor for manufacturing processes and ERP-related tasks.
Act as the site expert in ERP system usage, specifically Microsoft Dynamics 365, supporting all users with training, real-time troubleshooting, and transactional oversight to achieve positive outcomes.
Manage all real-time ERP shop floor transactions, focusing on identifying and resolving variances, ensuring accurate material consumption, batch reconciliation, and inventory movements.
Float across areas to support operational gaps, provide temporary leadership coverage, or conduct targeted training and oversight sessions.
Provide support to off-shifts, as needed, particularly regarding ERP transaction resolution and training.
Ensure compliance with cGMP, data integrity, and aseptic processing principles during all job functions and while training others.
Support continuous improvement initiatives and identify opportunities to streamline ERP transactions and manufacturing processes.
Partner with Quality, Operations, and Training departments to ensure proper documentation, training records, and procedural compliance.
Serve as a role model for operational excellence, right-first-time execution, and strong communication.
Perform other related duties as assigned.
Basic Qualifications
Bachelor's degree in science, engineering, or business administration required.
Minimum of 10 years of experience in aseptic pharmaceutical manufacturing or an equivalent combination of education and practical expertise.
Demonstrated experience with ERP systems required; expertise in Microsoft Dynamics 365 strongly preferred.
Financial and operational fluency in manufacturing environments with a focus on variance management and production accuracy.
Subject matter expertise in aseptic manufacturing processes including formulation, clean and prep, sanitization, and filling.
Proven ability to train others in both technical execution and ERP transaction compliance.
Excellent verbal and written communication skills; ability to write and deliver technical training content.
Strong analytical and problem-solving skills, particularly in real-time manufacturing environments.
High degree of organizational skills, attention to detail, and commitment to quality.
Ability to work cross-functionally with production, quality, IT, and warehouse teams.
California residents should review our Notice for California Employees and Applicants before applying.
Equal Opportunity Employer
#J-18808-Ljbffr