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Manager, Manufacturing & Process Execution DAP

Resilience
USA
Full-time
Manager · 7+ years experience
Onsite
Discovered 3 days ago
Generative AI

Full Job Posting

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, 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.
  • Sponsorship or support for work authorization, including visas, is not available for this position.
  • Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
  • Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100,000.00 - $148,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

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