Senior Chemist, MSAT

Argenta; Shawnee (KS); On-site; USD 85,000 - 115,000; Full time

Job summary

Argenta is seeking a Senior Chemist, MSAT at our Shawnee, KS site to lead analytical method development, transfer, verification and validation of active ingredients and finished drug products. This role requires cGMP/GLP experience and strong instrumental skills to ensure quality and compliance.

You will mentor colleagues, set up new instrumentation, and ensure adherence to SOPs and lab practices, while collaborating with project teams and clients to drive successful outcomes.

Qualifications

• Bachelor's degree in chemistry or related field with 6+ years in cGMP/GLP lab (BS) or 3+ years (MS).
• Proficient in HPLC and GC analysis and reagent preparation.
• Experience with wet chemistry methods (pH, viscosity, density, particle size).
• Mass spec experience preferred.
• Able to operate and troubleshoot lab instrumentation; GMP/FDA knowledge.
• Strong data interpretation and written/oral communication.

Responsibilities

• Prepare and maintain records for method development, transfer, verification and validation of analytical methods per cGMP.
• Lead method transfer and verification protocols and associated reports.
• Develop cleaning validation protocols and produce detailed reports.
• Develop analytical methods to assess purity, potency and stability of drugs.
• Manage workload, meet schedules, and coordinate with project teams.
• Serve as backup and mentor for lab staff; lead new instrumentation setup and qualification.
• Interpret USP/EP/JP monographs and analytical methodologies.
• Write SOPs and provide training to others as SME in lab practices.
• Perform root cause analyses and document investigations.
• Provide SME input on project calls with internal and external teams.

Skills

Data analysis

Written communication

Verbal communication

GMP/FDA knowledge

Industry trends awareness

Education

Bachelor's degree in chemistry

Master's degree preferred

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 Senior Chemist, MSAT at our Shawnee, KS location. This position leads 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. The position requires analyzing in-process, raw materials and finished product of pharmaceuticals for quality, safety, purity, strength and identity by conducting analysis as specified in the applicable specification requirements following GLP and cGMP guidelines. Serves as a mentor/lead to other analytical development positions in such areas as equipment utilization, SOP understanding and application, and good lab documentation and lab practices. Position has training responsibility for the department once qualified and will have data review responsibility. Position will lead setup and qualification of new instrumentation and equipment in the laboratory as required. Position is responsible and accountable for the success of analytical method establishment for new and/or existing products to the site.

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 and verification protocols, method validations and reports.
• Designs and execute the cleaning validation protocols keeping detailed reports used to assist in writing reports.
• Lead 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.
• Serves as backup and delegate for laboratory manager.
• 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.
• Provides technical subject matter expert input and addresses work performed on project calls both with internal project teams and to external clients.

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 6 years of work experience with B.S. or 3 years 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.
• Demonstrated ability to operate laboratory analytical instrumentation and be able to assist in the troubleshooting and calibration of laboratory equipment.
• Knowledge of GMP and FDA manufacturing regulations
• Ability to analyze 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, click here: www.argentaglobal.com