Project Manager (Regulated Industry)

Loxo; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

Loxo is seeking a Project Manager with pharmaceutical industry experience, specializing in technology transfer and process validation for solid dosage forms (tablets and capsules). You will coordinate cross-functional activities, ensure regulatory alignment, timelines, and project objectives, while driving Lean and Right First Time initiatives.

The role requires onsite work in Puerto Rico East/South, immediate availability, and Puerto Rico residency.

Qualifications

• Bachelor’s degree in Science, such as Pharmacy or Engineering.
• 5-7 years of pharmaceutical industry experience, with technology transfer and process validation.
• Immediate availability and Puerto Rico residency.
• Onsite work in East/South Puerto Rico.

Responsibilities

• Coordinate project development strategies to align with site strategy and product sourcing.
• Lead impact and feasibility assessments for product changes.
• Coordinate and track project requirements across relevant functions.
• Identify resources and form project teams.
• Negotiate and establish implementation timelines.
• Ensure checklists are current for each project lifecycle.
• Develop timelines for new products and launches.
• Coordinate product launch activities and tech transfers.
• Identify issues impacting launches and transfers and implement contingencies.
• Promote Lean and Right First Time initiatives.
• Drive process improvement in manufacturing and project activities.
• Ensure harmonized use of local and global systems.
• Support budget preparation and assumptions for new products/transfers.
• Ensure regulatory compliance for project activities.

Education

Bachelor's degree in Science

Pharmacy or Engineering

5-7 years pharmaceutical industry experience

Technology Transfer

Process validation

Lean

Right First Time (RFT)

Job description

Title: Project Manager (Pharmaceutical Industry)

Location: East/South of Puerto Rico

Eligibility: Puerto Rico Residents Only

Work Arrangement: Onsite

Employment Type: Contract-to-Hire

Start Date: Immediate availability required

Position Summary

Our client is seeking a Project Manager with experience in the pharmaceutical industry, particularly in Technology Transfer and process validation for solid dosage forms, including tablets and capsules. This role will coordinate cross-functional activities related to new products, product presentations, transfers, process improvements, and product launches while ensuring alignment with site strategies, regulatory requirements, timelines, and project objectives.

Key Responsibilities

• Coordinate project development strategies to ensure alignment with site strategy and support the product sourcing management process.
• Lead impact and feasibility assessments for product changes.
• Coordinate and track project requirements across relevant functions.
• Identify and assign appropriate resources and support team formation for projects.
• Negotiate and establish implementation timelines.
• Ensure the appropriate checklist is used for each applicable project and remains current throughout the project lifecycle.
• Develop high-level timelines for new products and new product presentations.
• Develop product launch strategies and coordinate activities required to support successful implementation.
• Anticipate, identify, and communicate potential issues that may affect product launches or technology transfers.
• Develop contingencies and alternative approaches and initiate corrective actions when necessary.
• Support and promote Lean and Right First Time (RFT) initiatives.
• Drive Process Improvement initiatives related to manufacturing and project activities.
• Ensure the site appropriately and consistently uses harmonized local and global systems.
• Support managers with business-unit budget preparation and the development of budget assumptions for new products and technology transfers.
• Ensure project activities comply with applicable regulatory requirements.
• Serve as a liaison with the Center New Products team, Global Sourcing, Supply Chain Management (SCM), Global Technical Services (GTS), and Regulatory teams for new products and technology transfers.
• Support Technology Transfer activities for solid dosage forms, including tablets and capsules.
• Support process validation activities within manufacturing for tablet products.

Minimum Qualifications

• Bachelor’s degree in Science, such as Pharmacy or Engineering.
• 5-7 years of experience in the pharmaceutical industry, including relevant experience related to the responsibilities of the position.
• Experience with Technology Transfer for solid dosage forms, including tablets and capsules.
• Experience with process validation within manufacturing, particularly for tablet products.
• Immediate availability is required.
• Must be a Puerto Rico resident.
• Must be available to work onsite in the East/South area of Puerto Rico.