Sr. Metrologist

Tris Pharma Inc; South Brunswick (NJ); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision, Rx insurance

401K with match

Paid Company Holidays

PTO

Employee Resource Groups

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks an experienced Senior Metrologist to support analytical laboratories through routine calibration and verification of complex instruments such as HPLC/UPLC, GC, UV-Vis, and FTIR. You will document results and assist investigations, under cGMPs and company SOPs.

The role requires collaboration with management, development of SOPs, training of junior staff, and strong adherence to quality systems. Monmouth Junction location, five days per week.

Qualifications

• Bachelor's degree in Chemistry, Engineering or related field with 6+ years GMP lab experience.
• Experience with FDA, cGLPs, cGMPs, SOPs and regulatory guidelines.
• Hands-on metrology calibration and troubleshooting of analytical instruments (HPLC/UPLC, GC, UV-Vis, FTIR, etc.).
• Experience performing or assisting in laboratory/metrology investigations.
• Experience creating or revising SOPs.
• Proficiency with Empower and/or other lab software.

Responsibilities

• Perform routine calibration and instrument verification on HPLC/UPLC, GC, UV-Vis, FTIR, GCMS, ICPMS, and more.
• Document calibration results and maintain good documentation practices.
• Initiate investigations related to instrument calibration failures or other instrument issues.
• Create, review, and revise SOPs for metrology activities.
• Train and mentor lower-level Metrologists and assist during routine metrology.
• Ensure compliance with cGMPs and safety regulations.

Skills

GMP metrology

HPLC/UPLC calibration

GC calibration

UV-Vis spectrophotometry

Troubleshooting instrumentation

Empower software

Education

Bachelor's degree in Chemistry/Engineering or related field

Tools

Empower software

Job description

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.

We have an immediate opening in our Metrology department in Monmouth Junction, NJ for an experienced Senior Metrologist.

The Sr. Metrologist supports Analytical laboratories by performing routine calibration and instrument performance verification, maintenance and repairs on highly complicated instrumentation including, but not limited to: High Pressure Liquid Chromatography/Ultra Performance Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), ultra-violet visible spectrophotometry (UV-Vis), Fourier Transform Infrared (FTIR), Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter, ICPMS, GCMS, 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

• 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)

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• 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

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

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.

Additional 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. 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. #LI-office