Key Facts

Remote From:

Category: Chemist

Full time

English

Hard Skills

Analytical Procedures Dosage Calculation Verification And Validation Pharmaceutical Formulation FDA Regulations Instrument Troubleshooting Openlab Scientific Writing Cross-Functional Collaboration Laboratory Safety +2 more

Other Skills

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Communication
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Teamwork
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Time Management
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Self-Motivation
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Problem Solving

Roles & Responsibilities

BS, MS, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field
Hands-on experience with HPLC and UPLC systems
Strong experience in analytical method development and validation
Familiarity with FDA, OECD, and GLP regulatory requirements

Requirements:

Develop, optimize, and validate analytical test methods for dose formulation analysis
Preparation of formulations (e.g., solutions, suspensions) to be used in toxicology studies
Perform analysis of dose formulation samples using HPLC/UPLC, and interpret analytical data with high accuracy and scientific rigor
Prepare and review Method Development/Validation and Dose Formulation Analysis (DFA) reports for GLP toxicology studies; Function as Study Director on analytical validation studies

Frontage Laboratories, Inc

Pharmaceuticals

About Frontage Laboratories, Inc

Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.

Company type: SME

Industry: Pharmaceuticals

Founded: 2018

Company size: 501 - 1000

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Job description

Analytical Chemist

Title: Analytical Chemist

Location: Chicago, IL (on-site)

Reports to: Director Laboratory Operations

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Our Chicago, IL site provides toxicology testing and research laboratory services and specialized pre-clinical studies in support of pharmaceutical and biotechnology products.

Position/Job Summary:

The individual in this position is involved in studies that evaluate the safety and/or toxicity of various materials (e.g., pharmaceuticals, chemicals, etc.). This position involves formulating, developing and validating methodologies for dose formulation analysis. As needed, the Analytical Chemist supervises support personnel and reports to the Director of Laboratory Operations. This is a full-time on‑site position at our Chicago facility with no provisions for working remotely.

Roles and Responsibilities:

Frontage Laboratories is seeking a highly motivated and experienced Chemist/Scientist for the Dose Formulation Analysis (DFA) group supporting non-clinical toxicology studies conducted under GLP regulations.

Key Responsibilities:

Develop, optimize, and validate analytical test methods for dose formulation analysis.

Preparation of formulations (e.g., solutions, suspensions, etc.) to be used in toxicology studies

Perform analysis of dose formulation samples using HPLC/UPLC
Analyze and interpret analytical data with high accuracy and scientific rigor
Prepare and review Method Development/Validation and Dose Formulation Analysis (DFA) reports for GLP toxicology studies

Function as Study Director on analytical validation studies

Ensure compliance with GLP, SOPs, and regulatory guidelines
Maintain analytical instruments and troubleshooting method/instrument-related issues
Collaborate with toxicology, formulation, and study management teams to support study timelines

Prepares SOPs and study specific methodologies
Leads and coordinates activities of less experienced staff in specific assignments
Interact with Study Directors and help define study priorities and schedules
Implements and enforce the use of safety procedures
Completes tasks within time and budget constraints
Demonstrates the ability to contribute to the success of assignments
Performs other duties as assigned

Qualifications and Experience:

BS, MS, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
Hands-on experience with HPLC and UPLC systems.
Experience with Mass Spectrometry will be preferred.
Strong experience in analytical method development and validation.
Experience supporting Non-GLP and GLP non-clinical toxicology studies is preferred.
Excellent scientific writing and documentation skills.
Ability to work independently and in a fast-paced CRO environment.
Experience in dose formulation analysis for toxicology studies.
Familiarity with FDA, OECD, and GLP regulatory requirements.
Experience with Agilent Open Lab software.

Salary: $65-80k, negotiable based on experience.

Benefits:

401k Employer Match with immediate vesting
Vision Insurance
Medical and Dental Insurance with multiple coverage options
FSA (Medical, Dependent Care, and Commuter)
Short Term Disability
Long Term Disability
Life Insurance
Generous Paid Holidays and PTO

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.