Sr. Metrologist

Tris Pharma Inc•South Brunswick, NJ

6d•$95,000 - $115,000•Onsite

About The Position

Tris Pharma, Inc. is a privately-owned US biopharmaceutical company focused on developing and commercializing innovative medicines. They have a significant number of patents and market several branded ADHD products. The company is seeking an experienced Senior Metrologist for their Metrology department in Monmouth Junction, NJ. This role supports Analytical laboratories by performing routine calibration, instrument performance verification, maintenance, and repairs on complex instrumentation. The Senior Metrologist will work closely with laboratory management, perform special projects, and write/assist with investigations related to instrument calibration failures. The company emphasizes a collaborative and respectful work environment.

Requirements

Bachelors in Chemistry, Engineering or related scientific field and minimum 6 years lab experience in a GMP related industry or minimum 8 years related experience handling analytical equipment in pharmaceutical or biotechnology industry working in Metrology, Method Validation (MV), Quality Control (QC) or related laboratories REQUIRED
Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations, and guidelines REQUIRED
Hands on experience performing routine metrology, calibration, maintenance and/or troubleshooting of analytical instrumentation (i.e., HPLC/UPLC, GC, Dissolution Apparatus and Autosamplers, UV-Vis, Density Meter, Balances, Ovens, Viscometers, Melting Point apparatus, Refractometer, Polarimeter, Media Dispenser Ezfill, etc.) REQUIRED
Experience performing or assisting in laboratory or metrology investigations REQUIRED
Previous experience creating, reviewing, or revising SOPs REQUIRED
Proficiency with Empower and/or other laboratory software REQUIRED

Responsibilities

Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
Performs routine calibration and instrument performance verification, maintenance, and repairs on highly complicated instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, GCMS, ICPMS, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.
Processes and reports calibration results using instrument specific data processing software; Documents all activities in legible manner following established formats and good documentation procedures
Initiates, writes and assists investigation related to instrument calibration failures or another instrument related issues
Creates, reviews and revises SOPs related to metrology activities
Initiates change control related to analytical instrument
Assesses critical analytical instrument/equipment performance
Executes analytical instrument qualification protocols and drafts qualification reports
Contacts and obtains technical information from vendors or service providers
Analyzes samples to evaluate instrumentation performance and troubleshoot instrument malfunction and/or breakdown, etc.
Trains and mentors lower-level Metrologists and assists them during routine metrology
Safely and properly dispose of chemical waste, as needed
Complies with all company policies and procedures, including safety rules and regulations and adheres to cGMPs and current Good Documentation Practices (cGDPs)