Project Manager, Research & Development


Job ID 17-00196

Industry Pharma

Job Type Permanent

Location Cranbury, NJ

Description

Would you like to have the opportunity to work with a talented team, experience many challenges and grow professionally? Do you want to play an active role in company and not get lost in the shuffle? With this company, you will not just be a number. Apply with us today to get your career on a fast track!
DESCRIPTION
Our Project Manager will handle diversified responsibilities in our expanding Research & Development facility located in Cranbury, NJ.  The Project Manager provides business and technical leadership for the new generic products development in the area of injectables, topical, ophthalmic, orals, and nasal drug candidates. This role involves managing the project and leading the project teams through the implementation process to final deliverable for the project/product. You will lead high performing cross-functional product development teams for managing the CMC activities involved with sterile pharmaceutical product development and manufacturing site transfers. The Project Manager will assist in the development and negotiation of contracts with CMOs, establish and lead cross-functional product development teams and act as the focal point for division senior management program communication. This person will interact with, and influence senior internal and external stakeholders. In addition, they will provide input to the program prioritization process and participate in other key strategic business portfolio processes to insure that the development programs being funded meet the business' strategic objectives. Project Managers will make launch date commitments to products based on team stakeholder's approvals and manage stakeholder expectations with regards to  deliverables during drug development process. 
You will be expected to provide leadership in facilitating problem solving and decision making by the team and to assure the decisions are consistent with the overall commercial objective of the program. Conduct meeting logistics, and communicates project status by preparing standard status reports, and by participating and documenting departmental and customer project status update meetings. Provide recommendations for addressing project related issues.  
Essential Duties and Responsibilities
Drive implementation of alliance projects by establishing development strategy, schedules, and budgets.
Lead and manage the projects effectively and to ensure they are delivered on time, on budget, and to agreed quality standards.
Managing standards, procedures and practices of record-keeping of all the agreements and contracts of the company.
Conduct team meetings with internal and external stakeholders; develop agenda, meeting minutes, and action items for team members.
Follow the Quality Assurance and Regulatory requirements for the assigned project.
Ensure project scope is clearly defined; develop and manage project plans to meet deliverables.
Responsible for identifying critical project issues and risks, and timely communication to senior leadership
Resolves project issues by working with team members, project customers, and others as appropriate.
Act as point of contact for project reporting & update.
Excellent communication and time management skills to meet expectations of all stakeholders.
Maintains direct interaction with R&D, quality, regulatory, operations, and manufacturing organizations 



Qualifications

Qualifications
BS/BA degree in health sciences required
Experience in pharmaceutical industry is required
Generic pharmaceutical manufacturing and topical drug experience highly preferred
Minimum of 7 years in product development or equivalent experience
Minimum of 4 years R&D project management experience
Knowledge of applicable quality and regulatory standards requirements for Pharma industry
Understanding of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Process requirements
Demonstrated leadership skills in collaborating and influencing cross-functionally.
Strong organizational and interpersonal skills.
Strong planning and execution skill.
Strong written and oral communication skills
Critical thinking/problem-solving skills
Demonstrated competencies in all aspects of project management
PMP certification desired  

CANDIDATE DETAILS
5 to 7 years' experience
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel – Occasionally
IDEAL CANDIDATE
Understanding of the entire drug development cycle with experience managing more than one stage.  Must be able to explain how to develop the project timeline and utility of PM tools.  Solid medical device industry candidates will be considered if they have worked with combo pharma/device products.    
SKILLS AND CERTIFICATIONS
PMP certification preferred
MBA preferred