Project Manager II

Accountable to the Director Project Management, the Project Manager II manages a variety of cross-functional projects including strategic initiatives, new business development opportunities, contract manufacturing, product launches, manufacturing compliance, and alternative supplier sourcing and qualification. The projects they manage are characterized as medium risk and complexity, important to business success, generally taking advantage of existing assets and processes, and involving multi-functional teams including internal and external stakeholders and participants.

Responsibilities

Leads a variety of cross-functional projects including strategic initiatives, new business development opportunities, contract manufacturing, product launches, manufacturing compliance, and alternative supplier sourcing and qualification; Typically leading 2-5 projects each with 4-10 team members, supported by a Project Coordinator per project; Delivery of assigned projects on budget, on schedule, and on scope; Organizes, manages and leads projects from specification to turnover, for processes and equipment, outside of routine production; Leads cross-functional teams from Production, Process Engineering, Pharmaceutical Development & Formulation, Maintenance and Technical Services, Validation, Quality Assurance, Quality Control, Microbiology, Regulatory Affairs, Environment/Health/Safety, Logistics & Supply Chain; Generates and maintains project charters, project plans, schedules, resource plans and project documentation; Responsible for project governance and accountable to Steering Teams, Sponsors, and Joint Steering Teams; Manages project budgets, change orders, forecasts, and invoicing at payment milestones; Conducts risk assessments and escalates risks and mitigations to management; Serves as main point of contact for CDMO clients; Documents formal project closure with appropriate approvals; Executes projects in compliance with PMO policies, GMP, EHS, and company policies; Mentors PM Is and PCs in project management discipline; Performs other related duties as assigned

Requirements

Bachelor of Science or Engineering / Engineering Science degree from a recognized academic institution; Minimum of 5 years of experience in leading projects or initiatives in a manufacturing environment, preferably in pharmaceutical CMO/CDMO manufacturing; Excellent communication, interpersonal and customer service skills including effective meeting facilitation and presentation skills; Ability to deal with difficult situations in high-pressure environments in a professional manner; Significant experience and skill presenting in front of clients at a leadership level, through both written and verbal communication; Excellent organizational skills with strong attention to detail; Strong planning and organizational skills with detail oriented; Proficiency with Microsoft Office applications, including Project, Excel, Word, Vision and PowerPoint; Understanding and routine application of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Processes required; Demonstrates initiative, ownership, effective problem-solving, self-motivation, and is a team player; Able to periodically travel internationally in support of projects when required

Nice to have

Pharmaceutical industry experience; Project Management Professional (PMP) certification

Benefits

Excellent compensation/benefits package; Discounted gym memberships; Programs supporting work life balance (EAP); Corporate Discounts and PERKS; Employee recognition program; Social events and spirit days; Paid time off; Comprehensive benefits; Bonus eligibility; Professional development support