Metrologist II

Tris Pharma Inc; South Brunswick (NJ); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

bonus eligible

medical

dental

vision

Rx insurance

401K with match

life insurance

paid Company Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. is seeking a Metrologist II at our Monmouth Junction, NJ headquarters. The role supports analytical laboratories by calibrating and maintaining instrumentation (HPLC/UPLC, UV-Vis, FTIR, GC, dissolution) under cGMPs, SOPs and FDA guidelines.

You will document activities, troubleshoot issues, and mentor junior staff. Minimum requirements include a Bachelor's in Chemistry, Engineering, or related field and 3–4 years of GMP-related lab/metrology experience, with strong

Qualifications

• Bachelor's degree in Chemistry, Engineering or related field and 3+ years GMP lab experience or 4+ years in analytical equipment metrology in pharma/biotech.
• Experience with FDA, cGLPs, cGMPs, SOPs and regulatory guidelines.
• Proficiency with Microsoft Office; strong verbal/written communication.

Responsibilities

• Perform routine calibration and instrument verification on HPLC/UPLC, GC, UV-Vis, FTIR, dissolution and related equipment.
• Document all activities following SOPs and data integrity practices.
• Investigate calibration failures and coordinate with vendors for service.
• Train and mentor junior metrologists and support multiple projects.

Skills

Metrology

Calibration

GMP/cGMP

HPLC/UPLC

GC

UV-Vis

Dissolution

Documentation

Excel

English fluency

Education

Bachelors in Chemistry/Engineering

Tools

Empower software

Job description

Description

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 II.

SUMMARY

The Metrologist II 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.

ESSENTIAL FUNCTIONS

Primary duties/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 more complicated instrumentation such as HPLC/UPLC, GC, H-class, 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
• 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
• Adheres to cGMPs and current Good Documentation Practices (cGDPs)

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

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.

Special knowledge or skills needed and/or licenses or certificates required:

• 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.)
• 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
• Fluent in English (verbal and written)
• Ability to identify and distinguish colors
• Ability and willingness to work additional hours required by business needs

Special knowledge or skills needed and/or licenses or certificates preferred:

• 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

Travel requirements:

0%

Physical requirements:

• 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

Anticipated salary range:

Metrologist II: $75,000 to $95,000 annually. 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.

Additional benefits:

• bonus eligible
• medical
• dental
• vision
• Rx insurance
• 401K with match
• life insurance
• paid Company Holidays
• PTO
• Paid Volunteer Time
• Employee Resource Groups

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

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