Sr. Metrologist

About the role

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories. Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

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)

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
• Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, SOPs and regulatory rules, regulations, and guidelines
• 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.)
• Experience performing or assisting in laboratory or metrology investigations
• Previous experience creating, reviewing, or revising SOPs
• Proficiency with Empower and/or other laboratory software

Schedule

This position requires working in our Monmouth Junction, NJ labs five (5) days per week.

Pay

Anticipated salary range: $95 to $115k/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Benefits

In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package.