Program Manager - Kavis Pharma LLC

POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

The Project Manager oversees and manages site and technical transfer projects from inception through completion, to include responsibilities for project scope execution, budget, schedule, performance standards, project teams, and communications.  Serve as primary liaison for existing commercial customers and products.  This individual is expected to work independently with external customers and internal business partners on commercial and development projects as assigned.   

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this position successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Manage projects from inception through completion. Develop and administer project budgets, schedules, and performance standards. 

1. Facilitate and/or lead internal, external and regularly scheduled commercial and project team meetings to drive timely communication, performance, and understanding of requirements.  This includes meeting organization, agenda preparation, meeting minutes, and actions items as required with the support of the Project Coordinator, where applicable.

1. For commercial and development projects/products, serve as the primary liaison between the customer and Kavis Pharma cross functional teams.

1. Leverage project outcomes locally, assisting other business areas where needed on major projects. Coordinate project activities with other departments and ongoing projects. Handle and respond to requests for changes from the original scope and budget or expense changes. 

1. Provide leadership and motivation to project team members throughout the project life cycle and into commercial. 

1. Work closely with Planning and Production Scheduling to manage capacity and customer demand.

1. Understand Manufacturing Service Agreements to include pricing, terms, liability, renewal options and unique outliers specific to each contract customers.

1. Work with site personnel to ensure customer delivery requirements and priorities are visible and are being actioned appropriately.

1. Support and implement annual pricing reviews and ensure premiums are captured and communicated to the customer based on the manufacturing agreement.

1. Work with functional teams (i.e., Engineering, Operations, QC, QA, Validations, Technical Services, etc.), as appropriate, to prepare and submit cost quotations to the customer for existing commercial business and new projects as assigned.

1. Responsible for measuring and delivering project outcomes successfully. Implement and/or adapt processes and metrics to ensure project goals and objectives are achieved. Set performance objectives and incorporate feedback from the team and organization for continuous improvement. 

1. Assign duties, responsibilities, and scope of authority to project personnel.  Manage and coordinate activities of project team to ensure the project progresses in scope, on schedule, and within budget.  Hold regular project review meetings with stakeholders, ensuring any concerns, issues, and successes and escalated to senior management in a timely manner.

2. Ensure the scope of work is included in the protocols and protocols are executed according to the established project requirements and timelines.

3. Assist with material introductions, requesting and disseminating test samples, creation of protocols, specifications, and support vendor interactions as necessary to complete material and process introductions. Expedite materials and documents through internal documentation and approval systems.

1. Understand and comply with all Kavis Pharma LLC safety, environmental and quality practices, and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.

2. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.  

3. Perform other duties as assigned.

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE 

Must possess knowledge of project management concepts, practices, and procedures. Must possess a strong working knowledge of the pharmaceutical industry.

SKILLS AND ABILITIES

Must possess excellent analytical, written, and verbal communication, interpersonal, planning, problem solving, and project management skills. Must possess a strong work ethic and have good organization, time management, and decision-making skills. Must have strong computer skills and be proficient within the Microsoft Office Suite.

SUPERVISION

Position functions autonomously.

EDUCATION/EXPERIENCE

Minimum of a relevant Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration. 

LICENSES/CERTIFICATIONS

  Project Management Certification not required, but preferred.