High school diploma or equivalent required
Minimum Six months' experience working in a high-volume production environment
Some experience working with fixtures, hand tools, and microscopes
Basic computer, reading, and math skills (add, subtract, multiply, divide)
Good manual dexterity
Able to wear plastic/latex gloves or finger cots
Must wear PPE for specific work tasks
Ability to read engineering drawings and process procedures
Ability to follow instructions and procedures closely while offering suggestions
Speaks and reads the English language
Ability to detect visual defects using a microscope.
Able to wear a lab coat and safety glasses.
Ability to use tweezers.
Ability to control high Magnetism magnets.
Able to clean Optics using a microscope, alcohol, and cleanroom swabs.
Able to lift twelve pounds frequently throughout the shift.
All employees are required to follow the site EHS procedures and Coherent Corp. Corporate EHS standards.

QC Manager, Microbiology

Made Scientific

Princeton, NJ 08543

Director Clinical Microbiology

Atlantic Health

Convent Station, NJ 07961

Labcorp

Raritan, NJ 08869

Boston Scientific Corporation

Elizabeth, NJ 07202

Merck & Company

Rahway, NJ 07065

Genmab

Plainsboro, NJ 08536

Master's or PhD in a statistical discipline
8+ years of experience in relevant area preferred, or demonstrated capability
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
Experience with the relevant regulatory requirements for biostatistics processes and SOPs
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Experience directing multiple complex projects/studies in a technical capacity
Proven performance in earlier role/comparable role