Metrologist

Tris Pharma Inc•South Brunswick, NJ

2d•$65,000 - $95,000•Onsite

About The Position

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus 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 U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are 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 importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Metrology Department, located in our Monmouth Junction, NJ headquarters has an immediate need for a Metrologist. (Title/level and salary commensurate with experience and will be determined after the interview.) Summary The Metrologist supports Analytical laboratories by performing routine calibration and instrument performance verification, maintenance and repairs on instrumentation including, but not limited to: High Pressure Liquid Chromatography/Ultra Performance Liquid Chromatography (HPLC/UPLC), ultra-violet visible spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc. following analytical methods, United States Pharmacopeia (USP)/National Formulary (NF) Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. Collaborating closely with, and under the direct supervision of laboratory management, the incumbent carries out laboratory work to support laboratory activities and performs special projects as assigned. She/he also writes and assists investigation related to instrument calibration failures or other instrument related issues.

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Metrologist I - Bachelors in Chemistry, Engineering or related scientific field and 0-3 years lab experience in a GMP related industry or minimum 2 years related experience handling analytical equipment in pharmaceutical or biotechnology industry working in Metrology, Method Validation (MV), Quality Control (QC) or related laboratories.
Metrologist II - Bachelors in Chemistry, Engineering or related scientific field and minimum 3 years lab experience in a GMP related industry or minimum 4 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
Ability to follow procedures as written and report any discrepancies
Proficiency with Microsoft Office
Verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
Planning, organization and time management skills including the ability to support and prioritize multiple projects
Metrologist II will have 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.)
Fluent in English (verbal and written)
Ability to identify and distinguish colors Ability and willingness to work additional hours required by business needs
Laboratory based position
Ability to lift up to 30 lbs
Ability to use Personal Protective Equipment (PPE)
Ability to stand for extended periods of time

Nice To Haves

Experience performing or assisting in laboratory or metrology investigations
Experience working in laboratories supporting testing of multiple dosage forms of products (i.e., solid dosage forms, liquid dosage forms, suspensions, etc.)
Proficiency with Empower and/or other laboratory software

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 instrumentation such as HPLC/UPLC, UV-Vis, FTIR, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.; Performs routine daily calibration/verification checks for balances, pH meters, 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 other instrument related issues
Contacts and obtains technical information from vendors or service providers
Safely and properly dispose of chemical waste, as needed
Complies with all company policies and procedures, including safety rules and regulations
Adheres to cGMPs and current Good Documentation Practices (cGDPs)
Metrologist II will be responsible for training lower level Metrologists and analyzing samples to evaluate instrumentation performance and troubleshoot instrument malfunction and/or breakdown, etc.