Job Summary

Pharmaceutical Laboratory Setup & Development Specialist

Building a Peptide Testing Laboratory from the Ground Up

TruPeptides Testing Labs Inc. | London ,Ontario, Canada

Our objective is to hire someone who can take an existing laboratory space and equipment inventory and lead the process of turning it into a fully functioning peptide analytical testing laboratory.

About the Position

TruPeptides Testing Labs Inc. is establishing a specialized peptide analytical testing laboratory in Ontario.

We are seeking an experienced pharmaceutical laboratory qualified to take the lead in setting up and developing our testing facility from the ground up.

We are not simply looking for someone to operate existing laboratory equipment. We need someone who understands how to establish a pharmaceutical analytical testing laboratory, determine what is required, set up the instrumentation, develop analytical methods, establish testing procedures and bring the facility into operation.

The successful candidate will have significant hands-on experience in pharmaceutical analytical laboratories and the ability to lead the technical setup and development of a new testing facility.

Primary Responsibilities1. Complete Laboratory Setup

- Assess the existing laboratory space and determine infrastructure and equipment requirements.
- Develop a comprehensive laboratory setup and implementation plan.
- Identify all equipment, accessories, software, consumables and reference standards required.
- Plan laboratory workflows and equipment placement.
- Coordinate equipment installation, configuration and commissioning.
- Identify gaps in the existing equipment and recommend additional purchases.
- Establish laboratory procedures and prepare the facility for operational testing.

2. Analytical Equipment Installation & Configuration

- Set up and configure HPLC and UPLC systems.
- Install and configure LC-MS instrumentation.




- Establish instrument operating conditions and analytical workflows.
- Troubleshoot and optimize analytical equipment.
- Establish calibration, maintenance and performance verification programs.
- Coordinate equipment qualification, including IQ/OQ/PQ where applicable.

Experience with Shimadzu, Agilent, Waters and Thermo Fisher instrumentation is highly desirable.

3. Analytical Method Development

- Develop peptide testing methods from the ground up.
- Establish HPLC and UPLC methods for peptide purity and assay.
- Develop LC-MS methods for peptide identity and characterization.
- Establish sample preparation procedures.
- Develop impurity and degradation profiling methods.
- Optimize analytical conditions and establish system suitability criteria.
- Conduct method verification, validation and transfer as appropriate.
- Prepare analytical procedures and validation documentation.

4. Establish Laboratory Testing Capabilities

Lead the development of appropriate testing capabilities, including:

- Peptide identity and characterization.
- Peptide purity and assay.
- Impurity profiling.
- Heavy metals analysis.
- Endotoxin testing.
- Sterility testing, where within the laboratory's intended scope and appropriately equipped.

Determine the equipment, methods, standards and procedures required for each testing capability.

5. Quality Systems & Operational Readiness

- Establish laboratory SOPs and documentation.
- Develop quality control procedures.
- Establish equipment records and maintenance schedules.
- Implement appropriate data integrity and recordkeeping practices.
- Develop analytical method validation programs.




- Assist with applicable regulatory and accreditation readiness.
- Prepare the laboratory for routine analytical testing operations.

Required Experience

- Extensive experience in pharmaceutical or biopharmaceutical analytical laboratories.
- Hands-on experience with HPLC, UPLC and LC-MS instrumentation.
- Pharmaceutical analytical method development and validation.
- Experience with peptides, pharmaceutical APIs or complex pharmaceutical compounds.
- Experience setting up, commissioning or developing laboratory operations.
- Knowledge of pharmaceutical quality systems and GMP principles.
- Ability to independently plan and execute a laboratory setup project.

Important Applicant Requirements

This position requires pharmaceutical or biopharmaceutical analytical laboratory experience.

Applicants whose experience is limited to food, soil, agricultural, water, wastewater or environmental testing will not be considered.

We are not looking for someone whose only experience is routine sample testing or operating instruments using established methods.

Application Questions

Please answer the following when applying:

- Have you personally helped establish a pharmaceutical analytical testing laboratory from the ground up?
- Can you independently plan and oversee the setup of a new analytical testing laboratory?
- Have you installed, configured or commissioned HPLC, UPLC or LC-MS equipment?
- Can you develop peptide analytical testing methods from scratch?
- Have you established pharmaceutical testing procedures, SOPs and quality systems?
- What pharmaceutical analytical instruments have you personally worked with?
- Would you be comfortable taking responsibility for the complete technical setup and development of a new peptide testing laboratory?

Pay: From $65.00 per hour

Benefits:

- Flexible schedule
- On-site parking

Work Location: In person

📌 Pharmaceutical Laboratory Setup- Peptide Testing (Masonville)
🏢 TRUPEPTIDE TESTING LABS
📍 Masonville