Project Manager (Combination Products)

Location: Irvine, CA - Hybrid role (Tue - Thur onsite, Monday & Friday Work from Home)

Contract Length: 1 year (potential extension)

Pay Rate: $115 - $125

Project Manager (Combination Products)

The Project Manager -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.

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
• Driving continuous improvement on Program/project management processes and tools
• Direct management of project managers with responsibility for device/device constituent development projects

Qualifications:

• 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).

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.