Project Operations Manager

1 week ago

Hunt Valley, Maryland, United States Pharmaceutics International Inc Full time
Job Description

Overview:

The role involves collaborating with the Business Development and Contracts team, clients, and operational units to initiate new projects, ascertain necessary resources for project deliverables and timelines, and oversee projects until their completion. For designated projects (both R&D and Commercial), this position serves as the primary liaison with clients, responsible for organizing project team meetings, regularly updating key stakeholders on project progress, addressing issues, and managing various administrative tasks as needed.

Key Responsibilities:

  • Oversee multiple projects from R&D to cGMP, managing all facets of development including formulation, process development, analytical services, manufacturing, and packaging from early development stages through to Process Validation/PPQ.
  • Develop and maintain project schedules, timelines, and milestones; lead project meetings, document and distribute meeting notes; ensure the smooth flow of documentation within the organization and to client entities.
  • Collaborate with the Finance team to manage financial aspects tied to project objectives, as outlined in the project plan, and initiate change orders when project scope adjustments are necessary.
  • Work alongside Business Development to ensure project scope is adhered to for effective execution.
  • Foster collaborative relationships with both internal and external team members.
  • Proactively identify and facilitate the resolution of potential risks that could impact project timelines.
  • Direct daily operations of project team members, including scheduling, communication, and billing processes.
  • Engage with peers and other leaders across the organization to successfully achieve project objectives.
  • Facilitate internal and client project meetings, ensuring accurate capture of meeting notes and project timelines.
  • Manage alterations to project scope while maintaining project objectives; initiate change order requests to document additional work.
  • Formulate project plans and ensure effective execution of project tasks.
  • Support departmental activities and objectives to maximize performance.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree or equivalent combination of education, training, and professional experience that equips the individual with the necessary knowledge, skills, and abilities.
  • A degree in Physical Science or Business Administration is preferred.
  • A minimum of 3 years of Project Management experience in a healthcare-related field or specific Pharmaceutical CMC, Regulatory affairs, or R&D experience within the Pharma/CDMO sector is preferred.
  • Detail-oriented with the ability to anticipate potential issues and collaborate with both internal departments and external clients to devise contingency plans.
  • Exceptional communication, presentation, and organizational skills.
  • Proven track record of delivering projects on time while ensuring client satisfaction.
  • Strong work ethic with a customer-focused approach.
  • On-site support is required to interface and network with key internal stakeholders.
  • Experience managing internal resources and interacting with external contractors, vendors, and clients.
  • Ability to establish effective working relationships with other departments, including vendors, colleagues, and subordinates.
  • Possess the technical knowledge necessary to make informed decisions on development issues with minimal supervision.
  • Ability to analyze data and information to assess and resolve complex problems as needed.
  • Familiarity with applicable SOPs is essential.
  • Knowledge of electronic Quality Management Systems such as MasterControl and Trackwise is advantageous.
  • Understanding of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
  • Knowledge of cGMPs, industry standards, and regulatory guidelines is crucial.
  • Exhibit integrity and professionalism in all interactions.
  • Ability to communicate effectively with management, staff, regulators, and client representatives in both written and verbal formats.
  • Demonstrate accuracy in completing tasks according to established and shifting timelines.
  • Ability to make informed decisions regarding scheduling, resource allocation, and priorities.
  • Energetic, execution-focused, self-motivated, and organized individual accustomed to working in a high-pressure, deadline-driven environment.
  • Results-oriented and efficient.
  • Creative and open-minded, fostering an environment that encourages idea sharing.
  • Ability to work closely with a diverse customer and employee base, both internally and externally.
  • Proficient in working within a cross-functional team environment.
  • Fluency in English with legible handwriting is required.

Physical Requirements:

  • Ability to travel between and within facilities to engage with staff, operations, and projects as necessary.
  • Capability to sit, stand, climb stairs, and navigate ladders to mezzanines when required.
  • Ability to lift up to 40 pounds occasionally.
  • Willingness to use PPE (safety shoes, goggles, respirators, gloves, etc.) when necessary.

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