Product Manager

Hemo bioscience a small biotechnology company based close to RTP has an opening for a Product Manager. The Product Manager is responsible for providing technical expertise and direction for the manufacturing and marketing pipeline to support existing and new products at Hemo bioscience. The Product Manager will support the manufacturing staff and other departments by assisting in the development of product specifications and standard operating procedures for the manufacture of products as well as providing day to day assistance as needed. This position will also liaise with the Regulatory Affairs/Quality Assurance Department in the planning and documentation needed for the investigation of complaints and CAPA’s. The product manager will play a key role in technical support to customers and will oversee lot release work and procedures, Quality control serology and technical review of Device History records. They will work alongside the Regulatory affairs department to assist with filing of regulatory submissions. They will work alongside and assist the Product development manager in the role of new product development.

Skills required:

Excellent Knowledge of blood bank techniques and Blood group serology

Manage a small testing laboratory with 2 staff

Closely interface with marketing staff to produce product information.

Activities:

· Follows SOPs, best laboratory practices, current good manufacturing practices and current good documentation practices to ensure products are manufactured to meet specifications.

.· Provides suggestions for better production and staff performance.

· Assists management for various production related duties.

To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

· Minimum Associates degree with MLS(ASCP) certification and SBB or PhD

· cGMP manufacturing experience and quality management system experience is preferred.

Salary is dependent on experience and qualifications.

Hemo bioscience, an established and growing biotechnology company headquartered in Research Triangle Park (RTP), North Carolina, develops and manufactures immunohematology reagents and related products for the world wide transfusion diagnostics market. Our customers include industry partners, reference laboratories, buying groups, hospital blood banks, and donor centers. Hemo bioscience's in-house research, development and manufacturing activities are led by blood bank trained scientists who are committed to improving the science of transfusion technology.

When life depends on reliable results, you can rely on Hemo bioscience - "The science in blood banking"