Production Assistant - Molecular Diagnostics

Position: Production Assistant

Reporting Authority: Director of Projects

Location: Ann Arbor, Michigan

GenePath Diagnostics is a leading molecular diagnostics company headquartered in Ann Arbor, Michigan. GenePath specializes in the customizable design, development, and manufacturing of PCR and NGS reagents for infectious disease, oncology, and genetic applications. Our robust and cost-effective molecular diagnostic solutions enable healthcare professionals to make accurate diagnoses, guide treatment decisions, and improve patient outcomes.

GenePath Diagnostics operates an R&D and production lab in Ann Arbor as well as a state-of-the-art clinical lab and R&D facility in Pune, India. We are an innovation-centric company with a strong emphasis on continuous R&D, and working closely with clinicians to develop affordable, high quality and scalable solutions. Examples include creating one of the world’s most efficient genetic tests for population screening of Spinal Muscular Atrophy (SMA), building a high quality and affordable solution for chronic myeloid leukemia (BCR-ABL) and one of the most sensitive and specific tests for COVID-19. We are a unique company in that we are both an advanced R&D team as well as a cutting-edge lab, thereby allowing rapid feedback between the two steps, to create truly world class products and services.

At GenePath, we strongly believe in our culture and our company’s values are the principles and ideals that we live by.

Key responsibilities:

As a Production Assistant, you will be primarily responsible for the operations at our production lab located in Ann Arbor. Your responsibilities will also include:

· Production of RT-qPCR molecular diagnostics assay components by adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

· Performing raw material, semi-finished goods, and finished goods QC.

· Maintaining Batch Manufacturing Record (BMR), inventory records, regulatory documents and production SOPs.

· Performing experiments and documenting results.

· Maintaining inventory and sourcing raw materials.

· Compilation of data, analysis, and interpretation of data.

· Maintenance of equipment and production facilities.

· Troubleshooting, optimization and drafting of new SOPs.

· Working closely with:

o Production planning and sales departments to ensure adequate inventory of finished products to meet sales demands.

o QA & Regulatory Departments for compilation & drafting of QC documents, product manuals, training

materials etc.

Critical Skills and Responsibilities:

1. Hands on experience of molecular biology techniques such as PCRs, RT-PCRs, NA extraction

2. Proficient with qPCR machines and software including BioRad and ThermoFisher machines.

3. Training in diagnostics R&D, manufacturing, QC, or application support preferred.

4. Knowledge of nucleic acid extraction, purification techniques and nucleic acid workflows.

5. Well versed with GMP and ISO 13485 guidelines.

6. Proficient in Google workspace and Microsoft Office.

7. Familiarity with Quality Systems and controlled document management.

Qualification & Experience

· M. Sc. (Molecular Biology /Biochemistry/ Biomedical Sciences/ Biotechnology)

· 2-3 years’ experience