Skip to content

Job Openings

Project Manager III (Engineering/Device/Combination Product)

Irvine, CA 92612

Posted: 08/31/2023 Employment Type: Contract Job Category: Project Management Job Number: 582005 Is job remote?: Yes Country: United States

Job Description


Target PR Range: 90-110/hr
*Depending one experience

Description

The Project Manager, Project Management -Combination Products is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Primary Packaging, Accessories, Secondary Packaging, Instructions for Use and Labeling). The Project Manager ensures 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.

Summary of Responsibilities and Accountabilities:

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 include:

· 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

· Driving continuous improvement on Program/project management processes and tools

· Direct management of project managers with responsibility for device/device constituent development projects

Qualifications

Basic:

· Required: Bachelor’s Degree in Engineering or related technical field

· Certification: Project Management Professional (PMP) Certification preferred, but not required

· 10+ years of experience in the combination product or medical device industry with proven experience in developing and launching combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.

· Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of delivery systems

· On-body delivery systems, auto-injectors, pumps and pre-filled syringes, and smart packaging design experience desired.

· Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.

· Requires an in-depth understanding of the pharmaceutical and device product development cycle.

· Design history file, project management and product development experience is essential.

· Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.

· Ensure timely execution of incoming reportable device combination product events to comply with global regulations.

· Must have working understanding and application of GMP principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America).

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.