Project Manager - Operational Excellence

Position Overview

Job Specifications

• Essential Job Duties & Responsibilities:
  • Develop and manage project schedules, track key milestones, and guide projects through all phase gates (initiation, planning, implementation, and closure).
  • Generate Risk Mitigation Plans, Risk Registers, and overall Project Plans for large initiatives summarizing scope, qualification, submission strategy, and timeline.
  • Lead and manage plant projects impacting capacity expansion, reliability, process improvement, and quality/compliance.
  • Coordinate on-time project implementation and change control approvals with Manufacturing, Quality Assurance, Facilities, Maintenance, Validation, QC, and Materials Management.
  • Facilitate team discussions to clarify roles, align timelines, identify roadblocks, and escalate critical delays to higher-level management when required.
  • Support the Associate Director of Project Management and assist in standardizing PMO governance, processes, and templates.
  • Provide leadership for ongoing validation projects and scientific/technical advice regarding projects as needed.
  • Strict adherence to cGMPs, FDA regulations, safety policies, and documentation standards.
• Qualifications & Requirements:
  • Education: Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry, or a closely related scientific/technical discipline is required. PMP training and certification is desired.
  • Experience: Minimum 5 years of experience in the pharmaceutical industry, including 3 years in increasingly complex project management duties within a cGMP operations environment.
  • Technical Knowledge: Understanding of principles and qualification requirements for systems/equipment such as ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, and filter presses; strong knowledge of cGMPs, FDA regulations, and industry guidelines.
  • Core Skills: Strong technical writing, organizational, analytical, and problem-solving skills; proactive self-starter with strong attention to detail, emotional intelligence, and team leadership capabilities.
• Occupational Demands:
  • Primarily office-based environment with frequent sitting (6 8 hours/day) and repetitive hand movements.
  • Light to moderate lifting up to 25 lbs; occasional walking, standing, bending, and neck twisting.
  • Frequently drives to site locations with occasional travel within the United States.

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.