Job Title: Laboratory Chemist

Location: Moncton, New Brunswick – On-site

Position Type: Full-Time, Permanent

Reports To: Quality Manager with dotted line daily oversight by Production Manager

Position Summary The Laboratory Chemist is responsible for conducting analytical testing, in-process and analytical validation activities, and finished product release testing to support the manufacture of chitosan-based products in accordance with approved procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP). Reporting directly to the Quality Manager, this role supports all laboratory testing, process validation, stability program management, method validation, and coordination of external contract laboratories.

The Laboratory

Chemist plays a critical role in ensuring the quality, safety, and consistency of raw materials, intermediates, and finished products throughout the product lifecycle.

Key Responsibilities

Process Support & Analytical Testing

- Process validation support: Perform analytical testing and sampling activities associated with product development, process validation, qualification studies, and process performance verification.
- In-process testing: Conduct routine in-process testing of raw materials, intermediates, and finished products to verify compliance with established specifications.
- Sample management: Collect, prepare, label, and maintain samples in accordance with approved sampling plans and laboratory procedures.
- Operations Support: Support Operations and production as required
- Analytical instrumentation: Procure, operate, calibrate, and maintain laboratory instrumentation including pH meters, viscometers, moisture analyzers, spectrophotometers, and other analytical equipment.
- Method execution: Execute validated analytical methods and test procedures while ensuring accuracy, precision, and compliance with laboratory standards.
- NMR analysis: Perform and interpret Nuclear Magnetic Resonance (NMR) analyses for characterization and quality evaluation of chitosan products and related materials. Experience with NMR instrumentation is strongly preferred.

Release Testing & Quality Support

- Finished product release: Perform analytical testing required for batch disposition and release of finished products.
- Specification review: Evaluate test results against approved specifications and immediately report out-of-specification (OOS),



out-of-trend (OOT), or atypical results.

· Deviation reporting: Immediately notify the Quality Manager and manufacturing supervision of any out-of-specification results, process deviations, equipment issues, or safety hazards identified during batch execution. · Investigation support: Assist in laboratory investigations, root cause analyses, corrective actions, and preventive actions associated with quality events.

- Trend analysis: Monitor and trend analytical data to support continuous improvement and process consistency.

Stability Program & External Laboratory Management

- Stability oversight: Manage and monitor stability studies, including sample pulls, testing schedules, data review, and reporting.
- Stability documentation: Maintain accurate stability protocols, records, summaries, and data trending reports.
- External laboratory coordination: Manage sample submissions to contract testing laboratories and ensure testing is completed according to approved timelines and specifications.
- Vendor communication: Serve as a liaison with external testing laboratories regarding analytical methods, testing requirements, results, investigations, and technical inquiries.
- Data review: Review and assess third-party laboratory results to ensure completeness, accuracy, and regulatory compliance.

Documentation & Compliance

- Laboratory documentation: Maintain complete, accurate, and contemporaneous laboratory notebooks, worksheets, logbooks, and electronic records.
- Data integrity: Adhere strictly to cGMP and data integrity requirements, ensuring all records are attributable, legible, contemporaneous, original, and accurate.
- Standard procedures: Create and follow laboratory SOPs, safety procedures, Material Safety Data Sheets (MSDS), and company PPE requirements.
- Regulatory compliance: Support laboratory operations in accordance with applicable regulatory, quality, and safety standards.

Required Qualifications & Experience

Education

- Minimum Requirement:



Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Asset: Advanced education or specialized training in analytical chemistry, polymer chemistry, or pharmaceutical sciences.

Skilled Experience

- Industry tenure: Minimum 3–5 years of laboratory experience in pharmaceutical, biotechnology, natural health products, medical device, chemical manufacturing, or other regulated environments.
- Analytical testing experience: Experience performing analytical testing, method execution, validation activities, and quality control testing.
- Regulated environment: Working knowledge of cGMP requirements, laboratory investigations, and documentation practices.
- Chitosan experience: Experience working with chitosan products, biopolymers, marine-derived materials, or related products is desirable.

Technical Skills

- Analytical instrumentation: Proficiency with laboratory analytical equipment and test methods.
- GXP Documentation: Strong understand of all applicable GXP laboratory standards associated with API, excipient, drug and medical devise products
- NMR expertise: Experience operating, interpreting, or supporting Nuclear Magnetic Resonance (NMR) analysis is preferred.
- Data analysis: Ability to analyze analytical data, identify trends, and prepare technical reports.
- Computer skills: Proficiency with Microsoft Office applications, laboratory information management systems (LIMS), and electronic documentation systems.

Preferred Qualifications

- Experience supporting product development, process validation, equipment qualification, or method validation programs.
- Familiarity with ISO, ICH, USP, or other applicable analytical and quality standards.
- Experience managing stability programs and third-party contract laboratories.
- Understanding of polysaccharide, biopolymer, or chitosan characterization techniques.
- Strong technical writing and scientific reporting skills.

Physical Requirements

- Ability to work in a laboratory and manufacturing environment.
- Ability to wear required personal protective equipment.
- Ability to lift up to 25 lbs (11 kg) and handle routine laboratory materials and equipment.
- Ability to stand, walk, and perform laboratory activities for extended periods as required.

Pay: $38,958.29-$96,877.10 per year

Work Location: In person

📌 Laboratory Chemist (Moncton)
🏢 Chitolytic AC Manufacturing
📍 Moncton