Project Manager II - Pharmaceutical Manufacturing

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

About the role

The Project Manager II provides dedicated, cross-functional project management of development, technical transfer, and operational activities that support the product lifecycle within the manufacturing site (e.g., purchase orders, forecasting schedules, change orders, invoicing, and shipping project management activities). The role executes a client engagement model and governance, assures effective and routine open communications and relationship management discussions with internal functional groups, as well as external client groups. The Project Manager is responsible for ensuring project milestones and budget are met, including ensuring pass-through and change order costs are accounted for. The role is vital to business and development/tech transfer growth at the site.

The Project Manager is expected to be on-site a minimum of three to four days per week, with additional consideration to prioritize client visits and other client-engaging requests, in accordance with business needs.

Responsibilities

• Support timelines during the quotation process and engage with Business Development early-on to ensure successful handoff when contract is signed.
• Organize client visits, both from a due diligence and person-in-plant perspective.
• Ensure financial forecasting and invoicing are as planned; develop contingency plans if not.
• Manage and forecast project budgets, ensuring change orders are passed on in a timely manner.
• Manage both internal and external team meetings for assigned clients; provide constant feedback and fast turnaround to internal and external partners.
• Execute client communications associated with routine engagement, messaging, escalation, and notifications.
• Manage and execute appropriate escalation for client matters within the PDS Management Team, appropriate functions, site leadership, and the CDMO Business Unit.
• Serve as site operations business manager, working with site and Supply Chain leadership to:
  • Assure client support prioritization alignment with product forecast and production priorities.
  • Manage client inventory position; communicate client’s product necessity in market and their relevant business strategies and plans.
  • Facilitate efforts of the Ambassador team to deliver the highest levels of service, attention to client inquiries, escalation, and needs for existing business.
  • Assure connection and information sharing across site functions and with the CDMO Business Unit.
• Coordinate efforts to facilitate client product handoff from new product introduction and qualification activities to run-the-business portfolio management duties.
• Orchestrate and assure close management and execution of improve-the-business activities (continuous improvement, deviation investigation, and corrective/preventative action efforts) with assigned clients.
• Execute highly effective routines, tools, templates, and associated guidance for business meeting preparation, setting agendas, and standard work to aid client engagement experience.
• Ensure safe and compliant execution of activities, including collaboration with EH&S for client safety when on site.
• Execute goals and accountabilities based on agreed objectives and results.
• Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.
• Promptly notify management, the team, and Quality leadership of potential issues or problems.

Requirements

• B.S./B.A. degree in Project Management, Business, or a related pharmaceutical sciences field, or equivalent experience in a regulated industry. PMP certification preferred.
• 6+ years cGMP experience in solid oral dose pharmaceutical (preferred), biotech, or bio-pharmaceutical manufacturing environment, ideally from pre-clinical phases to commercial, and/or equivalent experience managing commercial operations or client portfolio management roles.
• Comprehensive understanding of finance—including invoicing, financial forecasting, and the impact of planning in pharmaceutical or bio-pharmaceutical manufacturing operations.
• 6+ years’ experience in planning, orchestrating, and managing business-critical relationships between providers/suppliers and clients.
• Experience working with the FDA (Food and Drug Administration) and participating in regulatory agency inspections desirable.
• Strong interpersonal and collaborative/facilitative skills across functions, internal business enterprise, and externally with multiple clients within a portfolio.
• Proven, effective communication skills (oral and written); ability to drive and be assertive.
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding compliance-related issues with minimal supervision; proactive in identifying risks and creating mitigation plans.
• Demonstrated, proven record of personal accountability and responsibility with a delivery-focused mindset.

Pay

Compensation range: $108,000 - $150,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health coverage including medical, dental, and vision insurance.
• Retirement savings plans with employer contributions.
• Paid time off and flexible work arrangements.
• Professional development opportunities.
• Employee wellness programs and resources.
• Employee Assistance Program and Mental Health Resources.