Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.
ROLE SUMMARY:
Reporting 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. Clients may include external CDMO customers or internal Kindeva product customers. This role collaborates extensively with Quality Leads and Technical Process Engineers. The CPRM provides dedicated, cross-functional project management of operational activities that supports the product lifecycle within the manufacturing site. The role executes a client engagement model and governance, assures effective and routine open communications and relationship management discussions with internal Kindeva functional groups, as well as external client groups. The CPRM 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 technical transfer translating into commercial supply. The CPRM also works as part of the team to review and execute continual process improvement methods for enhancing client satisfaction and business growth.
ROLE RESPONSIBILITIES:
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.
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 Client Portfolio & Relationship Management strategic objectives.
Promptly notifies line management & Quality leadership of potential issues or problems.
Responsible for organizing the product transfer to manufacturing.
Responsible for interfacing with the Client and Kindeva to ensure all relevant product and process information is received.
Create a project tracker, schedule, process flow, and Gantt for a kickoff meeting.
BASIC QUALIFICATIONS:
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.
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).