Project Manager

Location: Los Angeles, CA
Department: Azzur of CA, LLC

Job Description

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
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Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!



Ideal Qualities

  • The candidate must have a strong understanding of the Asset Lifecycle Management process in the Pharmaceutical Industry.  The position reports to Engineering Director, leads and manages customer corporate CAPEX and site specific OPEX projects of medium to high complexity, ensuring on-time and on-budget delivery of project goals.  This includes managing capital projects including:
  • Budgeting and forecasting
  • Capital Projects Approval CPA justification presentations
  • Managing general contractors and sub-contractors including training and qualifications
  • Resolving scope changes with engineering, site quality (when applicable) and construction
  • Construction management including adherence with design specifications (URS, FS, DS)
  • Working with stakeholders on construction packages including format and content
  • Working with stakeholders on vendor selection and qualification
  • Develops agreements with stakeholders for resources, roles and responsibilities
  • Requests for information to meet qualification requirements
  • Team meetings, forecasting including input from contractors, accrual methods
  • Working with procurement on equipment purchases as well as contractor agreements
  • Coordination of construction with EHS to ensure safety of personnel
  • Maintains project schedule with appropriate milestones and escalates obstacles and issues
  • Provides regular project updates to the appropriate stakeholders
  • Assists director with business process and program improvements
  • Willingness to learn and expand comfort zone 
  • Cross functional medium to large scale projects
  • Corporate strategy, manufacturing site specific, or R&D type projects
  • Development of various program level business processes
  • Process Improvements

Qualifications:

  • Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus
  • Working knowledge of FDA/EU regulations and requirements for biologics and pharmaceuticals in a project management role
  • 5-10 years of project management experience in pharmaceutical/biotech
  • Provide support to help define project scope, budget and schedule for equipment, utilities and facilities.
  • Prepare requests for proposal (RFPs), cost estimates and provide justification (i.e., business cases) for capital projects
  • Strong knowledge of project management tools including schedules, communication plans, risk plans, resource plans, scope & change management tools, action item trackers, and project plans
  • Strong knowledge of MS Project, Primavera or equivalent as a tool to create integrated timelines and monitor project progress
  • Maintain SharePoint and/or other databases with project status and key project information
  • Excellent facilitation, negotiation, conflict resolution skills, and cross functional collaboration skills to foster positive business relationships with the ability to network with different functional areas
  • Excellent interpersonal, verbal and written communication skills in a collaborative work environment 
  • Follow-up on action items between team meetings and ensure accountability of team members
  • Work with the Director, functional management, and governance teams to resolve conflicts and issues with projects and ensure alignment throughout the organization
  • Understand and translate requestor’s strategies into plans, and be able to drive the project to completion
  • Apply expertise as a project manager within the biotech/pharma industry to successfully deliver project and program outcomes while managing stakeholder expectations
  • Identify risks and contribute to issue resolution
  • Effectively frame and present information to senior leadership
  • Maintain a high level of expertise in the field of project management and within the biotech/pharma industry
  • Provide technical review and comments on project specifications, drawings and other technical documents including SOPs, User Requirements Specifications (URS), Functional Design Specifications (FDS), Protocols, Factory Acceptance Test (FAT) plans and Site Acceptance Tests (SAT) plans
  • Manage and supervise construction and installation contractors performing equipment, utility and facility work during project execution
  • Support Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems to identify and address high-risk failure modes
  • Project Management Certification is a plus





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