Manufacturing Project Manager - Los Angeles, United States - Kindeva Drug Delivery

Description

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies.

We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

This role will have the responsibility of maintaining schedules, budgets, and Cost of Goods (COGs) as they relate to the technical development of Manufacturing Processes in Kindeva commercial sites, and at our Outsource Partners.

The individuals in this role must possess both technical aptitude in the development of manufacturing processes, and the proven experience in the cross-functional coordination of technical professionals.

Ready to be part of a team with purpose? Look no further, we are hiring for a talented Manufacturing Project Manager to join our Northridge team.

Key Responsibilities Include

Leads development of Project Charter and documents the initial requirements that satisfy the stakeholder's needs and expectations.
Highly engaging, cross departmentally and with a majority of work being completed on site and interactive with various stakeholders.
Scope project requirements in support of new product / product line extension projects and/or product optimization projects.
Work with the engineering team to ensure specification/requirement compliance in the areas of: design, system performance, quality, and COGs.
Ensure all projects are executed within Health, Safety, Environmental and GMP requirements.
Resourceful and action-oriented to remove barriers to success and achieve results despite occasional limited resources or challenging work environment.
Participate in phase gate reviews internally, with external partners, and customers.
Strong verbal and written communication to include technical communication skills to accurately convey technical issues and information.
Projection of unit costs and CAPEX spend to get from development to commercialization.
Customer facing communication and coordination working with both internal and external project teams
Working with external manufacturing operations

Position Qualifications

Bachelor's Degree in Engineering or related technical field.

• 5 years' experience with project management.

New product development experience is a plus.
Experience with ISO 13485, 21 CFR 210/211/820 is preferred.
Requires track record of detailed program management exhibiting comprehensive planning and thorough communication.
Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating project requirements.
PMP certification or equivalent formal project management tools training highly preferred.

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