Senior Project Manager

Orion Group; Irvine (CA); Hybrid; USD 113,652 - 161,868; Full time

Benefits offered by this job

Medical insurance

401(k)

Vision insurance

Job summary

A life science recruiting firm is seeking a Project Manager III to lead drug delivery system projects for a pharmaceutical client in Irvine, CA. The ideal candidate will have over 8 years of experience in the medical device industry and will manage a cross-functional team. This mid-senior level position offers a hybrid schedule on a 2-year contract with a competitive pay rate.

Qualifications

• 8+ years of experience in the combination product or medical device industry.
• Proven experience in developing medical devices or combination products.
• In-depth understanding of the pharmaceutical and device product development cycle.

Responsibilities

• Lead a portfolio of drug delivery system product development projects.
• Manage project governance process with external device partners.
• Ensure effective communication with cross-functional leadership.

Skills

Leadership

Communication

Risk Management

Scheduling & Organization

Problem-Solving/Process Improvement

Education

Bachelor’s degree in engineering

Project Management Professional (PMP) Certification

Tools

Project management tools

Job description

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Overview

Life Science Recruiter dedicated to helping individuals find their next opportunity of success, with life science organizations located in the US!

2-yr contract

Hybrid Schedule- 9 am-5 pm

$100/HR

Irvine, CA

Orion Group is seeking a Project Manager III for combination products development, who will be accountable for leading the cross-functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.) for our pharmaceutical client in Irvine, CA.

The Project Manager will ensure that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.

The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans, and budget defined for the project portfolio.

Responsibilities

• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners, including acting as a key interface, managing the project governance process, and forward-looking evaluation of potential partners
• Device financial management, including budgeting, forecasting, and long-range planning of delivery development expenses
• Representing the R&D organization to cross-functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed, and publishing minutes and actions
• Ability to motivate teams, delegate tasks effectively, and drive project success
• Communication: Excellent written and verbal communication skills to manage stakeholders and team members
• Risk Management: Expertise in identifying, assessing, and mitigating project risks
• Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools
• Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements
• Requires an in-depth understanding of the pharmaceutical and device product development cycle
• Design history file, project management and product development experience is essential

Qualifications

• Bachelor’s degree in engineering (mechanical or biomedical engineering). A master’s degree in engineering or management is preferred but not required
• Certification: Project Management Professional (PMP) Certification preferred, but not required
• 8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation, and usability studies
• Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success
• Communication: Excellent written and verbal communication skills to manage stakeholders and team members
• Risk Management: Expertise in identifying, assessing, and mitigating project risks
• Scheduling & Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools
• Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Project Management

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

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Benefits: Medical insurance, 401(k), Vision insurance