Manager, Aseptic Process Operations

Kindeva Drug Delivery•Brentwood, MO

About The Position

The Aseptic Operations Support Manager is a critical role within our Aseptic Pharmaceutical Manufacturing Facility. This position is designed to engage and provide in-depth knowledge and expertise to cross-functional operational functions and ERP system across all production areas, to include but no limited to formulation, clean and prep, sanitization, aseptic filling, material handling, and warehouse operations This role will lead and manage key initiatives associated with company objectives as the subject matter expert and trainer, cross-training personnel and supporting colleagues with both technical and transactional leadership. A key responsibility of this role is to implement and resolve opportunities to ensure real-time ERP transaction accuracy, resolve actual variances, and maintain data integrity for all manufacturing-related activities. This individual will act as both a manufacturing SME (subject matter expert) and ERP transactional authority to drive right-first-time execution and data reporting integrity. The Aseptic Operations Support Manager will partner with the Operations Leadership Team (Directors, Managers, Supervisors) to ensure a robust plan is aligned with transformational change within our manufacturing facilities. The incumbent will demonstrate the behaviors that support the Company's PRECISE Values (Personal Responsibility, Respect, Excellence, Communication, Innovation, Service, Energy).

Requirements

Bachelor's degree in science, engineering, or business administration required.
Minimum of 10 years of experience in aseptic pharmaceutical manufacturing or 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.

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, with a focus 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.
Performs other related duties as assignment