Under minimal supervision, the incumbent is responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation and reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Management of project related activities from definition to release stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives.
- Organize and lead project core team meetings.
- Maintains effective communication and working relationships among project core team.
- Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties.
- Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings.
- Lead risk analysis & mitigation planning for projects.
- Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution.
- Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks.
- Prepare and present project progress reports and presentations as required.
ADDITIONAL POSITION REQUIREMENTS
- Ability to work with customers and internal technical stakeholders to translate manufacturing needs into an efficient and cost-effective plan including, but not limited to:
- Material Management
- Work with technical leads on the drafting of research and development protocols, material specifications and batch records
- Facilitate internal and external team meetings
- Understanding of GMP considerations for manufacturing projects including pharmaceutical development, manufacturing operations, validation, analytical development and testing.
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- learning new skills, procedures, and processes.
- Is available for other duties as required.
- Is available for overtime as needed.
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
Bachelor’s Degree required and five (5) years of project management experience in cGMP Pharmaceutical Manufacturing Project Manager or Project Coordinator; or ten (10) years of project management experience in cGMP Pharmaceutical setting as a Project Manager or Project Coordinator.
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4 and Annex 13.
- Demonstrate effective collaboration and teamwork.
- Demonstrate experience managing contract pharmaceutical projects on time and on budget.
- Demonstrate experience working in a cGxP environment.
- Familiar with project management tools and technologies such as Microsoft Project.
- Knowledge of various project management methodologies.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems.
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work with others in a team environment.
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
- The employee is occasionally required to sit and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- Travel will be required less than 20% of the time, domestic and international.
The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.
We are an Equal Opportunity Employer and all qualified applicants will receive
consideration for employment without regard to race, color, religion, sex, national origin,
disability status, protected veteran status, or any other characteristic protected by law.