Project Manager
: Job Details :

I. JOB SUMMARYReporting to the Director of Client Portfolio & Relationship Management (CPRM), this role is responsible for serving as the primary point of contact for an assigned portfolio of CDMO clients serviced through the Baltimore site. Clients may include external CDMO customers or other internal customers. This role collaborates extensively with other functional groups including Quality Leads and Technical Project Leads. The Project Manager provides dedicated, cross-functional project management of 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 supporting regular and routine performance management and business reviews. The role is vital to business and operational planning at the site and works to assure current client requests and support organizational needs. The person in this role integrates their understanding and knowledge of business plans and forecasts for Clients in the assigned portfolio with site Supply Chain leaders on matters of capacity and production planning. The Project Manager also works as part of the team to review and execute continual process improvement methods for enhancing client satisfaction and business growth. II. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Executes and manages client engagement model, which includes description of client management governance, agreements on routine operational communications / meetings, and periodic performance management discussions and business reviews Executes client communications, associated with routine engagement, messaging, escalation, and notifications. 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:o Assure client support prioritization alignment with product forecast and production prioritieso Manage Client inventory position, communicate Client's product necessity in market and their relevant business strategies and planso Facilitate efforts of Ambassador team to deliver highest levels of service, attention to client inquires, escalation and needs for existing businesso 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 executes client visits, including person in plant (PIP) visits. Supports 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. Promptly notifies line management & Quality leadership of potential issues or problems. Shares best practices across functional units. Project Manager is expected to be on-site a minimum of three days per week, with additional consideration to prioritize client visits and other client-engaging requests, and in accordance with business needs. 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. PMP certification preferred. 3-5 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. 3-5 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 across stakeholders 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. Proficiency in MS Office, Teams, and project management software (e.g., MS Project, Smartsheet). IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICSThe physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.Compensation Range:$121,954.00 - $182,931.00Bora 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