Typical Work Hours are: Monday through Thursday 7AM - 530PM; This is a salaried position.
GENERAL DESCRIPTION OF POSITION
The Project Manager coordinates and manages defined projects that support oral pharmaceutical product development, product transfer projects, new product commercialization/launch activities internal to the site, cost improvement projects, capital equipment installations and safety and compliance driven initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Fulfills the essential tasks and responsibilities on a daily basis. This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time.
2. Responsible for planning and executing their assigned projects, associated budgets, timelines and other project-specific deliverables within the scope of the initiative/project. This duty is performed daily, about 100% of the time.
3. Assess risks, develops mitigation plans and lead regular team meetings working across functionally with Manufacturing, Quality Assurance, Quality Control, Validation, and Regulatory departments. This duty is performed weekly, about 50% of the time.
4. Responsible for elevating unresolved issues, including timely communication to department management and engages and Governances that drive resolution as needed. This duty is performed weekly, about 25% of the time.
5. Acts as point of contact for project reporting and updating. Tracks projects and provides timely/relevant project status updates to management team. This duty is performed weekly, about 50% of the time.
6. Responsible for development of key processes and systems that are in compliance with cGMPs, regulatory standards, and company policies and procedures to organize/track and communicate initiative status to multi-disciplinary teams.
7. Perform any other related duties as required or assigned.
To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND EXPERIENCE
Four year college degree, in science or engineering is preferred, plus 7years related experience and/or training, and 5years related management experience, or equivalent combination of education and experience. Pharmaceutical ExperiencePreferred.
REQUIRED CERTIFICATES, LICENSES, REGISTRATIONS
Project Management Professional Certification.
SOFTWARE SKILLS REQUIRED
Intermediate: Alphanumeric Data Entry, Contact Management, Presentation/PowerPoint, Spreadsheet, Word Processing/Typing
Basic: Accounting, Database, Enterprise Resource Planning
ADDITIONAL SOFTWARE SKILLS
Experience in generic pharma desired and experience in liquid manufacturing preferred. Pharmaceutical product technical transfer and new product launch experiencerequired. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, attending multiple meetings and conference calls. Demonstrated leadership skills in collaborating and influencing cross-functionally. Strong organization and interpersonal skills needed.
No FDA sanctions