Project Manager II

Bora Pharmaceuticals•Maple Grove, MN

3d•$108,000 - $150,000•Onsite

About The Position

About 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. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary The Project Manager II provides dedicated, cross-functional project management of development, technical transfer, operational activities that supports 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 person in this role integrates their understanding and knowledge of technical, financial and commercial needs to ensure projects run smoothly. 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, and in accordance with business needs.

Requirements

B.S / B.A. degree in Project Management, Business or a related pharmaceutical sciences field or equivalent experience in regulated industry.
6+ years cGMP experience in solid oral dose pharmaceutical (preferred), biotech or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases to commercial, and / or equivalent amount of experience managing commercial operations or client portfolio management roles.
Comprehensive understanding of finance – invoicing, financial forecasting, and impact of planning in pharmaceutical or bio-pharmaceutical manufacturing operations.
6+ years’ experience and strength in planning, orchestrating, and managing business critical relationships between providers / suppliers and clients.
Experience working with FDA (Food and Drug Administration) and participating in regulatory agency inspections desirable.
Strong interpersonal and collaborative / facilitative skills across functions, across 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.

Nice To Haves

PMP certification preferred.

Responsibilities

In the PDS department, this role would support timelines during the quotation process and engage with BD early-on to ensure successful handoff when contract is signed.
This individual will help with organizing client visits, both from a due diligence and person in plant prospective.
This person has a significant role in ensuring financial forecasting and invoicing are as planned, and if not ensures there is a contingency plan to catch up.
Managing and forecasting project budgets and ensuring change orders are passed on in a timely manner are critical to this job function.
Manages both internal and external team meetings for assigned clients.
Provides constant feedback and fast turnaround to internal and external partners.
Executes client communications, associated with routine engagement, messaging, escalation, and notifications.
Manages and executes appropriate escalation for client matters within the PDS Management Team, appropriate functions, site leadership and the CDMO BU.
Serves 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 Ambassador team to deliver highest levels of service, attention to client inquires, escalation and needs for existing business
Assure connection and information sharing across site functions and with CDMO BU.
Coordinates efforts to facilitate client product handoff from new product introduction and qualification activities to run-the-business portfolio management duties.
Orchestrates and assures close management and execution of improve-the-business activity (continuous improvement, deviation investigation and corrective / preventative action efforts) with assigned Clients.
Executes highly effective routines, tools, templates, and associated guidance for business meeting preparation, setting agendas, and associated standard work which aid client engagement experience.
Works to ensure safe and compliant execution of activities, including collaboration with EH&S for client safety when on site.
Executes goals and accountabilities based on agreed objectives and results.
Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.
Promptly notifies management, the team and Quality leadership of potential issues or problems.