Job Summary:
The Project Manager (PM) will provide project management support primarily on Technical Operations/Manufacturing project teams. This individual will develop and maintain project schedules, facilitate meetings, issue meeting agenda/minutes, align with key stakeholders, ensure
communicate across project team, and deliver team goals and objectives. This position must be well organized, detail-oriented individual capable of synergizing with existing team members and promoting the Evofem culture in external relationships with suppliers.
Job Responsibilities:
Perform a wide variety of activities which may include the followings:
• Interact with contract manufacturing organizations (CMOs) to complete late stage product development, technology transfer, process validation and commercial manufacturing activities.
• Manage supplier contracting including MSAs, SOWs, and invoices. Prepare RFPs and detailed itemized proposal comparison.
• Ensure suppliers stay on-task and complete contracted work in timely manner through weekly conference calls. Confirm suppliers adhere to communication plan with necessary members of the Evofem team. Integrate deliverables and dependencies between suppliers seamlessly.
• Conduct and coordinate review of technical documents, protocols and reports from product development, manufacturing and other activities.
• Generate weekly status reports for all on-going activities. Prevent slippage from aggressive development and commercialization timelines. Develop contingency plans to quickly and efficiently adapt to challenges that may arise.
• Create forward-looking Gantt charts and project plans to guarantee timely initiation and completion of activities. Provide strategies to reduce technical and logistical risks. Identify root causes of issues to prevent in future projects.
• Ensure program team activities and decisions are clearly communicated, documented and archived.
• Interact with Evofem leadership, Product Development, Technical Operations and Quality staff, consultants and supplier personnel to successfully communicate expectations and responsibilities and to promote awareness of ongoing activities and upcoming deliverables.
• Keep detailed records of all activities, data, protocol and reports in central repository as directed by the Evofem leadership team. Maintain organization of central repository. Ensure necessary personnel have access to required documents.
Competencies:
• Proven ability to distill complex plans across multiple programs into an intuitive, simple and clear communication to facilitate prioritization and resourcing.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Independently motivated, detail oriented and great problem-solving.
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Strong proficiency with project management practices, tools and methodology including Gantt Charts, MS Project, SmartSheet and Power Point.
• Drive team accountability for deliverables, develop and deliver team recommendations to senior management, create and meet all program milestones.
Education and Qualifications:
• BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.
• 5+ years of relevant industry experience in the development and manufacturing of pharmaceutical drug product.
• Project Management Professional (PMP)/PMI certification or similar preferred.
• Previous experience with Process Scale-up/Improvement, Analytical Development, Technology/Assay Transfer, Process Validation and Manufacturing functions is preferred.
• 3+ years of Project Management at a fast-paced, innovative biotech/pharma company managing IND and NDA CMC projects.
• Experience working with and managing CMOs preferred.
Travel: 25% travel nationally and internationally.