Summary

PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.

Job description

Essential Duties and Responsibilities

Lead and manage complex engineering projects from initiation to completion.
Develop and implement project management strategies aligned with organizational goals.
Collaborate with cross-functional teams to ensure successful project outcomes.
Evaluate and optimize project processes to enhance efficiency.
Provide technical leadership and guidance to project teams.
Interface with clients and external partners to understand and meet project requirements.
Ensure a safe workplace for contractors and PCI employees.

Project Planning and Execution

Collaborate with clients and internal teams to define project scopes, objectives, and deliverables.
Develop detailed project plans, schedules, and budgets to ensure successful project execution.
Monitor project progress, identify potential risks, and implement proactive solutions to keep projects on track.
Monitor contractor's performance for compliance with contract terms and conditions; investigates, documents and/or resolves problems.
Approve invoices for payment or withholds payment; manage the execution, evaluation and closing of work orders and appropriate documentation.

Cross-functional Collaboration

Work closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless project integration.
Foster effective communication and collaboration among team members to optimize project outcomes.

Engineering Expertise

Apply engineering principles to design and optimize manufacturing processes, ensuring efficiency, scalability, and compliance with industry standards.
Troubleshoot and resolve technical issues that may arise during the project lifecycle.

Quality Assurance

Implement and adhere to quality assurance protocols to ensure the highest standards of product quality and regulatory compliance.
Collaborate with the quality assurance team to conduct risk assessments and implement corrective actions as needed.

Safety

Ensure contractor compliance with EH&S policies and procedures, including Hot Work and Lock Out Tag Out; uphold all safety procedures and safe practices.
Inspect contractor's work to ensure that safe work practices and standard operating procedures are followed.

Requirements

Bachelor's degree in engineering, Science, or a related field
Project Management Professional (PMP) certification is a plus
3-5 years' experience with GMP, ISO, and/or an FDA-regulated environment is required
Proven experience in project management, preferably in the pharmaceutical or biotechnology industries
Strong understanding of engineering principles and their application to pharmaceutical manufacturing processes
Proficient in project management methodologies and tools
Ability to drive initiatives to completion
Excellent communication and interpersonal skills with the ability to work collaboratively across departments
Detail oriented with strong analytical and problem-solving capabilities
Assertive, self-directed, and results-oriented
Resilient, can quickly move forward despite challenges
Must be able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment

Company overview

PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.