Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

This position is remote OR based in our Cranbury NJ office with flexibility to work from home 2 days/week. The successful candidate will be 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 launch 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.
• Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to:
• Material Management
• Manufacturing, Packaging & Labeling - Prepare documents such as, but not limited to, material specifications and batch records.
• Prepare required distribution documentation, enter & monitor shipments
• Prepare required Returns, Accountability and Destruction documentation.
• Manage all project related inventory to avoid stock out scenarios
• 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.
• Management of monthly project invoicing.
• 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.

ADDITIONAL POSITION REQUIREMENTS

• Lead risk analysis & mitigation planning for projects.
• Prepare and present project progress reports and presentations as required.
• 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.

QUALIFICATIONS: EDUCATION and/or EXPERIENCE

Bachelor's Degree preferred and three (3) years of project management experience in packaging, labeling and clinical supply chain as Project Manager or Project Coordinator; or six (6) years of project management experience in packaging, labeling and clinical supply chain as a Project Manager or Project Coordinator. Commercial packaging experience a plus.

LANGUAGE SKILLS

• 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.

TRAVEL

• Domestic travel will be required less than 5% of the time.

  EXPERIC is 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.