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Manufacturing Project Manager - Simi Valley California

Company: Kindeva Drug Delivery
Location: Simi Valley, California
Posted On: 05/04/2025

19901 Nordhoff St, Northridge, CA 91324, USAJob DescriptionPosted Thursday, December 21, 2023 at 5:00 AM - Expired Thursday, February 8, 2024 at 4:59 AMKindeva is a leading global contract developer and manufacturer (CDMO) with expertise in Autoinjector, Inhalation, and Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes worldwide. As One Team, we aim to manufacture many more tomorrows.This role involves maintaining schedules, budgets, and Cost of Goods (COGs) related to the technical development of manufacturing processes at Kindeva's commercial sites and our outsource partners. The ideal candidate will have technical expertise in manufacturing process development and experience in coordinating cross-functional teams.We are hiring a talented Manufacturing Project Manager to join our Northridge team. If you are ready to be part of a purpose-driven team, consider applying.Key Responsibilities Include:

Develop project charters and document initial requirements to meet stakeholder needs.

Engage cross-departmentally, primarily on-site, with various stakeholders.

Define project scope for new products, product line extensions, or optimizations.

Collaborate with engineering to ensure compliance with specifications in design, performance, quality, and COGs.

Ensure all projects adhere to Health, Safety, Environmental, and GMP standards.

Remove barriers to success proactively, even with limited resources or challenging environments.

Participate in phase gate reviews with internal teams, external partners, and customers.

Communicate effectively, conveying technical information clearly.

Estimate unit costs and CAPEX for development to commercialization.

Coordinate with internal and external project teams, including customer communication.

Work with external manufacturing operations.Position Qualifications:

Bachelor's Degree in Engineering or related field.
8+ years of project management experience.
Experience with new product development is a plus.
Familiarity with ISO 13485, 21 CFR 210/211/820 preferred.
Proven track record in detailed program management, planning, and communication.
Ability to lead integrated process teams and coordinate project requirements.
PMP certification or equivalent training is highly preferred.Safety is a key priority for Kindeva. We encourage vaccination and monitor external environments through our Covid-19 task force.Equal Opportunity Employer:Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other protected characteristic.
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