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Resilience

Biologics and sterile injectables CDMO

Manager, Manufacturing & Process Execution DAP

Manufacturing & Production OperationsConfirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USAIn-person

About the Job

Requirements

  • Advanced knowledge of packaging or manufacturing operations in a pharmaceutical, biotechnology, or other cGMP-regulated environment.
  • 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 to use Microsoft Office Suite and computer applications.
  • 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, with the 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, with the ability to evaluate complex, ambiguous problems and develop new solutions that affect multiple areas of the operation.
  • Experience working in a Lean manufacturing environment.
  • Working knowledge of generative AI language tools such as Claude.

Responsibilities

  • Own 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.
  • Confirm that the process is executed to standards by conducting process confirmations.
  • 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 its 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 performance across the operation.
  • Participate in the design, selection, installation, and qualification of new equipment, facilities, and processes.
  • Support life-cycle management of PET and facility assets, providing 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 safety expectations for the area 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.
  • Break down complex processes into clear documentation, guide the team on how to execute them, and communicate changes to the team.
  • 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, ensure training and qualification programs are in place, and partner with the Process Lead and Training Coordinator on plans and resources.
  • Manage and develop a team of direct reports, owning hiring, performance management, and career development.

About the Company

Resilience

Biologics and sterile injectables CDMO

Resilience is a North American CDMO focused on biologics and sterile drug products. It provides end-to-end services from development through commercial production, including biologics development and drug substance manufacturing, aseptic fill/finish, device assembly, packaging, logistics, regulatory support, and tech transfer, all coordinated via a stage-gate process and a digital quality management system. It differentiates itself with North American-based, integrated biologics and sterile capabilities, a focus on sterile injectables and device assembly, and recent expansion into injectable pen devices for diabetes and obesity medicines. Its goal is to broaden access to complex medicines while protecting North American biopharma supply chains with dependable capacity and strong regulatory support from clinical development to commercial scale.

Company size
1,001-5,000
Company stage
Growth Equity (Venture Capital)
Total funding
$3.2B
Headquarters
Blue Ash, OH
Founded
2020

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