Diagnostic Manufacturing Associate - Staff Icons

Northvale, NJ 07647

About the Job

Summary
The company has developed a proprietary, cost-effective molecular diagnostic assay to detect and identify bacterial and fungal pathogens in whole blood, without the need for culture. Currently, the company is finalizing its preparations for verification and validation required for a 510(k) submission.
Role
The Diagnostic Manufacturing Associate is responsible for the planning, implementation, and maintenance of manufacturing methods, processes, and operations for current and new products, as well as contributing to the improvement of production capabilities. The Diagnostic Manufacturing Associate is also responsible for understanding product specifications, troubleshooting technical problems, and implementing process improvements.
The ideal candidate should demonstrate initiative in accomplishing independent projects while effectively collaborating with and within project teams. The candidate will be expected to perform benchwork for certain manufacturing steps for the production of the diagnostic devices until a successful transfer of the procedures to CMOs is completed.
Responsibilities:

Produce products, kits, and reagents that meet product specifications and timelines.
Accurately and completely record production and in-process testing results in authorized batch records/Forms and work order documents.
Manage inventories, supplies, and equipment in order to achieve production plans.
Utilize technical knowledge to make detailed observations and analyze data to ensure they are within specifications.
Troubleshoot, identify, and resolve problems in manufacturing processes.
Assist in revising SOPs, batch records, and other production related documentation.
Assist in the review and validation of product development protocols, and implementing these procedures through the use of written approved work instructions.
Assist in maintenance and calibration of equipment that are used in production using established or manufacturer-supplied procedures
Communicate production status to the Supervisor in a timely manner, including any operational issues.
Assist in scheduling and preparation of purchase orders of raw materials to ensure timely delivery of products.
Assist in optimizing and improving existing product and manufacturing processes to assure highest product quality and reduced cost.
Ensure all transactions are appropriately reflected in the Inventory Management System, including master data setup and maintenance documentation.
Strong written and verbal communication skills to enable effective knowledge exchange between departments.
Other duties as assigned by supervisor

Requirements:

BS in Biochemical Engineering, Molecular Biology or Biotechnology with an interest in Manufacturing, Operations, Project Management, and Business.
6-8 years of work experience in the diagnostic industry or biotechnology/pharma, or a MS/PhD in a related discipline with 4-6 years of industry experience
Knowledge of cGMP requirements, familiarity with regulatory frameworks (Ex. ISO 13485)
Possess a good ability to facilitate team collaboration. Has experience working with teams towards common project goals.
Possess a good knowledge base in research principles, theories, design and implementation.
Prior experience performing experimentation (bench work) in a biopharmaceutical or molecular diagnostic process development laboratory is preferred (including PCR, nucleic acid extraction, microarray).
Current ability to perform bench work is required
Experience in experimental design/DOE, statistical analysis/SPC, and process optimization.
"Go getter” attitude to use initiative, knowledge, and experience to solve problems.
Possesses excellent communication, organizational, managerial, analytical, computer, and technical writing skills.
Organized and detail oriented, particularly regarding maintaining records and documentation.
Must be able to manage and adapt to rapidly evolving project priorities and timelines.
On-site presence 5 days per week required.

Source : Staff Icons