Metrologist - Monmouth Junction, United States - Tris Pharma

Description

Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and 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 it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.

Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Metrologist

SUMMARY:

The Metrologist supports laboratory departments 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 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 MV and QC 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, 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
• 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 new and existing chemists on instrument operation and maintenance, as appropriate
• Complies with all company policies and procedures, including safety rules and regulations
• Adheres to cGMPs and Good Documentation Practices (GDPs)

QUALIFICATIONS

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 3 years experience in pharmaceutical or biotechnology industry working in Analytical Research and Development (AR&D), Method Validation (MV) and/or 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 and willingness to work additional hours required by business needs
• Ability to identify and distinguish colors

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

• Experience performing or assisting in laboratory or metrology investigations
• Experience working with multiple dosage forms of products (i.e., solid dosage forms and liquid dosage forms)
• Previous experience creating, reviewing or revising SOPs
• Proficiency with Empower software

Travel requirements

0%

Physical requirements

Laboratory based position

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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