Chemist, MSAT

Argenta; Shawnee (KS); On-site; USD 80,000 - 110,000; Full time

Job summary

Argenta, Shawnee, KS, is seeking a Chemist, MSAT to support cGMP analytical method development, transfer, verification, and validation of active ingredients, raw materials, and finished drug products. You will manage multiple analytics projects and interface with client teams to ensure quality and timelines.

The role requires a BS in Chemistry with cGMP/GLP experience, proficiency in HPLC/GC, and familiarity with GMP/FDA regulations.

Qualifications

• Bachelor's degree in chemistry with cGMP/GLP experience.
• Experience with analytical methods and instrument operation.
• Familiar with GMP/FDA regulations and data interpretation.

Responsibilities

• Performs and maintains records for method development and finished product analysis.
• Designs and executes method transfer and verification/validation protocols.
• Develops analytical methods to assess purity, potency and stability of drugs.
• Ensures testing adheres to schedules and manages workload across projects.
• Reads USP/EP/JP monographs and analytical methods.
• Writes SOPs and provides training to staff.
• Conducts root cause investigations using standard analysis tools.

Skills

Data analysis

Written and oral communication

Team collaboration

Regulatory awareness

Education

Bachelor's degree in Chemistry

Tools

HPLC

GC

Mass spectrometry

Job description

At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.

We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.

Our Uniqueness Means

We are ambitious, growing and building a ‘one team’ culture, guided by our values.

• We are team players;
• We are doers;
• We are customer-centric;
• We are innovators.

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.

Argenta is currently looking to fill the role of Chemist, MSAT at our Shawnee, KS location. This position is responsible for supporting or leading the preparation of protocols and execution of cGMP analytical method development, transfer, verification, and validation of active ingredient, raw material, cleaning verification, and finished drug product analysis. Position manages multiple concurrent analytical projects and has client interface responsibility with client counterparts and project teams.

Key Responsibilities

• Performs and maintains accurate, detailed records for method development/optimization, method transfer/verification/validation, and for routine analysis of finished pharmaceutical dosages and/or raw materials following approved analytical methodology and specifications to pharmaceutical cGMP requirements.
• Independently manages the Design and execution of method transfer an/d or verification protocols, method validations and reports.
• Designs and executes the cleaning validation protocols keeping detailed reports used to assist in writing reports.
• Supports or leads the activities to develop analytical methods to assess the purity, potency, other key attributes, and stability of drug substances and finished products.
• Responsible in ensuring testing is in adherence to schedules through team-oriented process. Manages effectively own assigned workload and develops timelines for assigned projects to provide to management.
• Reads and interprets USP, EP, JP compendial monographs, and analytical methodology.
• Serve as a subject matter expert in advanced laboratory practices by writing SOP’s and providing training and guidance to other personnel.
• Utilizes root cause analysis tools and technical writing to independently complete laboratory investigations.

About You

• Bachelor’s degree in chemistry or related Science field with work experience in cGMP and/or GLP chemistry lab environment (a minimum of 2 years of work experience with B.S. or 1 year of work experience with masters (M.S) is preferred.)
• Proficient at HPLC and GC analysis and preparation of reagents and sample solutions for testing.
• Proficiency with wet chemistry testing methodologies and techniques such as pH, viscosity, density, particle size testing, titration.
• Experience with mass spec methods and instrumentation preferred.
• Knowledge of GMP and FDA manufacturing regulations
• Ability to analyse and interpret data
• Strong written and oral communication skills
• Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.

Argenta is an equal-opportunity employer

To find out more about Argenta, www.argentaglobal.com