SUMMARY

The Director, Project Management directs the PM Team and all related strategies for the successful planning and execution of all projects to support product manufacturing at Bora Pharmaceuticals Baltimore site. In addition to leading the Project Managers, this position acts as a full time PM with key clients while driving the execution of portfolio, and business management functions. This position also functions as point of contact for escalations from the site for clients ("Clients" may be external CDMO customers or internal Bora Pharmaceuticals product customers).

This role collaborates extensively with stakeholders with focus on assuring appropriate, productive engagement with Clients, including but not limited to site operations and management clarity; attention to client inquiries, product portfolio and production plans; and provision of expected site services. The role executes an appropriate client engagement model and governance, assures effective and routine operational communications and relationship management discussions, and leads and facilitates periodic performance management and business reviews.

The role is a vital part of business and operational planning at the site and works to assure current client demands can be met. The person in this role integrates their understanding and knowledge of business plans and forecasts for Clients with site Supply Chain leaders on matters of capacity and production planning. This role works with CDMO Operations Team to understand each Clients view of the site as their CDMO, shares clients' views of the performance with site leadership, and advises on focus areas to enhance client satisfaction and business growth.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Executes and manages agreed client engagement models, which includes description of client management governance, agreements on routine operational communications /meetings, and periodic performance management discussions and business reviews
• Executes (as required) agreed guidance around client communications, associated with routine engagement, messaging, escalation, and notification
• Manages and executes appropriate escalation for client matters within the Client Portfolio & Relationship Management Team, appropriate functions, site leadership and the CDMO BU.
• Acts as primary liaison with the CDMO Commercial Operations team for ongoing client business, operational and contract management matters for the assigned client portfolio
• 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
  • Drives delivery of 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.
• Collaborates to achieve assure highest service-levels and engagement around management of Clients products at site; site operations and management clarity; attention to client inquires; product portfolio and production plans; service the site is expected to supply; initiates and follows-through on escalation, when required
• 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.
• Prepares and executes business and performance management discussions
• Prepares for and orchestrates client visits, including person in plant (PIP) visits, audits, and business reviews, in collaboration with other functions as required.
• Works to ensure safe and compliant execution of activities, including collaboration with EH&S for client safety when on site.
• Pursues individual development, training, and workload management
• Executes goals and accountabilities based on agreed objectives and results.
• Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• B.S / B.A. degree in Project Management, Business or a related pharmaceutical sciences field or equivalent experience in regulated industry. M.B.A. preferred.
• 10-15 years cGMP experience in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial, and / or equivalent amount of experience managing commercial operations or client portfolio management roles.
• Comprehensive understanding of business and operational planning, forecasting and impact of demand planning on biotech, pharmaceutical or bio-pharmaceutical manufacturing operations.
• 5-10 years' experience and strength in planning, orchestrating, and managing business critical relationships between providers / suppliers and clients.
• Experience working with FDA/ EU and participating in regulatory agency inspections preferred.
• Strong interpersonal and collaborative / facilitative skills across multiple functions, across internal business enterprise, and externally with large number of clients
• Proven, effective communication skills, oral and written
• Ability to make sound decisions regarding compliance-related issues.

Compensation Range:

$178,457.00 - $267,685.00

Bora Pharmaceuticals Injectables, Inc.  is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc.  will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category