Manager, Manufacturing & Process Execution DAP

Resilience•West Chester, OH

About The Position

The Manager, Manufacturing – DAP owns the performance of the DAP Line Operation, including its people, resources, schedule, and results. The Manager sets operational priorities and allocates staffing and equipment to meet production, quality, cost, and safety commitments under the PET (Process Execution Team) operating strategy. The role partners with MSAT, Engineering, and Quality to ensure operational deliverables meet site production and quality commitments. The Manager leads the DAP line operation and its technicians, engineers, and Supervisors, and is accountable for effective employee relations and compliance with cGMP, other regulatory and SOX requirements, EHS obligations, and Resilience standards. The operation is one where failures are difficult to recover from.

Requirements

Advanced knowledge of packaging or manufacturing operations in a pharmaceutical, biotechnology, or other cGMP-regulated environment.
Strong leadership, communication, and writing skills, with demonstrated ability to lead and develop direct reports.
Ability to determine and manage resources, timelines, and priorities to meet operational goals.
Ability to work with, lead, and influence cross-functional teams on initiatives affecting the DAP Operation.
Demonstrated ability using Microsoft Office Suite and computer applications.

Nice To Haves

Bachelor’s degree in Engineering, a related science, or Business.
Seven or more years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including previous supervisory or leadership experience.
In-depth knowledge of FDA cGMP and applicable domestic and international regulatory requirements sufficient to serve as the area's compliance subject-matter expert.
Strong technical writing skills and ability to translate complex processes into clear SOPs and communicate procedural changes to staff.
Strong problem-solving skills grounded in mechanical, electrical, and process troubleshooting fundamentals, including the ability to evaluate complex, ambiguous problems and develop solutions affecting multiple areas.
Experience working in a Lean manufacturing environment.
Working knowledge of generative AI language tools such as Claude.

Responsibilities

Own daily line-operation performance, deploying staff, equipment, and materials to meet production, quality, safety, and cost targets in accordance with area Standard Operating Procedures.
Conduct process confirmations to verify that processes are executed to standards.
Determine staffing levels, schedules, and shift coverage across the operation, balancing resources and timelines against demand and competing priorities.
Set operational goals for the line and direct reports; represent the line operation in cross-functional activities and client interactions; and perform Senior Manager duties when designated.
Own the area's continuous-improvement agenda, set KPI targets, and direct team-based problem solving to improve efficiency, quality, production, and safety.
Direct priorities and partner with MSAT and Engineering to resolve complex process problems and optimize operational performance.
Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes.
Support life-cycle management of PET and facility assets, including input on equipment needs and capital planning.
Coordinate across PETs and adjacent functions to ensure end-to-end product flow, resolve cross-team constraints, and standardize best practices and lean behaviors.
Set area safety expectations and hold the team accountable to external and Resilience EHS standards.
Maintain documentation practices to company standards across manufacturing documents, training records, and production logs.
Author, review, revise, and approve SOPs and work instructions to integrate cGMPs and improve process efficiency.
Translate complex processes into clear documentation, guide the team in execution, and communicate changes.
Ensure cGMP compliance with FDA and international regulations; serve as the process subject matter expert during internal audits and respond to observations in the area of ownership.
Investigate and resolve deviations, initiate and approve investigations as appropriate, and respond to product complaint notifications.
Own, evaluate, review, approve, and implement change control for the area.
Foster a positive work environment by administering people policies, communicating with employees, and responding to their concerns.
Build team capability by ensuring training and qualification programs are in place and partnering with the Process Lead and Training Coordinator on plans and resources.
Manage and develop direct reports, including hiring, performance management, and career development.