Manager, Manufacturing & Process Execution DAP

Resilience US; Olde West Chester (OH); On-site; USD 120,000 - 190,000; Full time

Job summary

Resilience is seeking a Manager, Manufacturing - DAP to own the daily performance of the DAP line, manage people, resources, and schedules, and ensure production targets are met with quality and safety standards. The role partners with MSAT, Engineering, and Quality to deliver site commitments under the PET operating strategy.

The position requires advanced knowledge of pharmaceutical manufacturing in a cGMP environment, strong leadership, and a track record of improving efficiency and safety.

Qualifications

• 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 a team.
• Ability to work with cross-functional teams to meet operational goals.
• Proficiency in Microsoft Office and related software.

Responsibilities

• Owns daily line operation performance, staffing, equipment, and KPI targets per SOPs.
• Coordinates staffing levels, shift coverage, and resource allocation against demand.
• Sets operational goals and represents the line in cross-functional activities and audits.
• Drives continuous improvement with KPI targets and problem‑solving initiatives.
• Collaborates with MSAT and Engineering to resolve complex process issues.
• Supports design, installation, and qualification of new equipment and processes.
• Maintains cGMP compliance; acts as SME during internal audits and investigations.
• Leads training, hiring, performance management, and career development.

Skills

Advanced knowledge of packaging or mfg

Leadership

Communication

Writing skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering, a related science, or Business

Tools

Microsoft Office Suite

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is needed . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Brief Job Description

The Manager, Manufacturing - DAP owns the performance of the DAP Line Operation-its people, resources, schedule, and results-setting operational priorities and allocating staffing and equipment to meet production, quality, cost, and safety commitments under the PET (Process Execution Team) operating strategy, and partnering with MSAT, Engineering, and Quality so the operation's deliverables meet site production and quality commitments. Leading the DAP line operation and its technicians, engineers, and Supervisors, the Manager is accountable for effective employee relations and for compliance with cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards, in an operation where failures are difficult to recover from.

Job Responsibilities

Core Responsibilities

• Owns the daily performance of the line operation, deploying staff, equipment, and materials to meet production, quality, safety, and cost targets in accordance with area Standard Operating Procedures.
• Confirms the process executed meets standards by conducting process confirmations
• Determines staffing levels, schedules, and shift coverage across the operation, balancing resources and timelines against demand and competing priorities.
• Sets operational goals for the line and its direct reports, represent the line operation in cross-functional activities and client interactions, and the Senior Manager duties when designated.
• Owns the area's continuous-improvement agenda, setting KPI targets and directing team-based problem solving to improve efficiency, quality, production, and safety.
• Directs the priorities of and partners with MSAT and Engineering to resolve complex process problems and optimize performance across the operation.
• Participates in the design, selection, installation, and qualification of new equipment, facilities, and processes.
• Supports life-cycle management of PET and facility assets, providing input on equipment needs and capital planning.
• Coordinates across PETs and adjacent functions to ensure end-to-end product flow, resolve cross-team constraints, and standardize best practices and lean behaviors.
• Sets the safety expectations for the area and holds the team accountable to external and Resilience EHS standards.

Documentation & Compliance

• Maintains documentation practices to company standards across manufacturing documents, training records, and production logs.
• Authors, reviews, revises, and approves SOPs and work instructions to integrate cGMPs and improve process efficiency.
• Breaks down complex processes into clear documentation, guiding the team on how to execute them, and communicates changes to the team
• Ensures cGMP compliance so all FDA and international regulations are met, and serves as subject matter expert for the process during internal audits, responding to observations in the area of ownership.
• Investigates and resolves deviations, initiates and approves investigations as appropriate, and responds to product complaint notifications.
• Owns, evaluates, reviews, approves, and implements change control for the area.

Training & Development

• Fosters a positive work environment by administering people policies, communicating with employees, and responding to their concerns.
• Builds team capability, ensuring training and qualification programs are in place and partnering with the Process Lead and Training Coordinator on plans and resources.
• Manages and develops a team of direct reports, owning hiring, performance management, and career development.

Minimum Qualifications

• 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 a team of direct reports and to determine and manage resources, timelines, and priorities to meet operational goals.
• Ability to work with, lead and influence cross-functional teams on initiatives that affect the DAP Operation.
• Demonstrated ability in the use of Microsoft Office Suite and Computer applications.

Preferred Qualifications

• Bachelor's degree in Engineering, a related science, or Business.
• 7+ 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,