Company – Diagnostics company
Location – Greater Philadelphia Area, NJ
Our client is a diagnostics company, part of a wider international group, providing best-in-class development and manufacturing capabilities to serve customers around the world. This arm of the group delivers products and services in lateral flow, ELISA, stains and reagents.
Development group leader, responsible for the safe, on-time delivery of product developments that meet the customer & quality requirements. Delivery on development milestones via a New Product Introduction Process, created and owned by this position.
The Development Group Project Manager is responsible for facilitating solutions to any problem faced by their team – although not necessarily expected to offer all technical solutions personally.
An education and experiential background in immunoassay/diagnostic/medical device development is required as all non-production scientists report to this position. Experience developing products in an ISO 13485/FDA 820 environment is required.
- Managing development of lateral flow assays, ELISA (assays), reagents, and other projects as prioritized by senior management.
- Collaborate with other teams including QA/QC, Engineering, Manufacturing, Sales, Marketing, Purchasing and Customer Service to meet project deadlines and customer expectations.
- Manage products with SCRUM; able to present to management in comprehensive format.
- Implement and continuously develop a New Product Introduction (NPI) Process, which is the transfer from Development to Manufacturing. Validation batches made by Manufacturing are included in development contracts, so you will share responsibility with Manufacturing Managers.
- Create and maintain visual KPI dashboards for accountability and cultural awareness.
- Represent the company as the development contact for customers, providing project updates to customers and help selling our capabilities.
- Create and maintain a career ladder for the development team, manage compensation and incentives for team.
- Recruit and dismiss employees, as required, with senior management’s approval.
- Attend conferences / visit customers with sales staff when appropriate.
- Degree in a related field along with general, broad-based scientific knowledge.
- 5+ years of experience immunoassay/diagnostic/medical device product development.
- Knowledge of immunoassay regulation, markets, design, and development; antibody and antigen development, purification and screening.
- Strong projects management skills, expertise in Scrum or Agile and be proficient with software to manage the process.
- Scrum master certification preferred, but good experience in a scrum/agile environment and/or willing to be certified is fine.
- Understanding of IVD approval processes and requirements.
- This position is a people and process management position – must have a proven track record of outstanding people management and process management skills.
Please submit your resume to us for a private and confidential discussion about the opportunity.