Optimi is a Canadian Good Manufacturing Practices (GMP) compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. The focus of the company is on pharmaceutical-grade psychedelics, including MDMA and naturally derived psilocybin products. From facilities in Princeton, British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and clinical trials in Israel, as well as accessible in Canada through the Special Access Program. Optimi also has an active Cannabis Analytical Testing License through Health Canada.The Sr. Analytical Laboratory Specialist is responsible for organizing and performing analysis of products according to pre-established methods and specifications for the material. In addition, the Sr. Analytical Laboratory Specialist will be involved in maintenance of analytical equipment, method development and validation for new products, and documentation activities.This is a full-time onsite role with no provision for remote working.Responsibilities:1.Routine Analytical Testing:Receiving, logging, and handling of samples (internal and external)Sample preparation according to established procedures and protocolsPerforming analytical testing of assigned samples within required deadlines.Analysis and reporting of results to QC Manager for generation of reports and/or COA'sSupervision and training of personnel for above duties2.Analytical Method Development and Validation/VerificationUse available literature and other resources to improve existing and develop new analytical testing methods that are compliant with relevant regulatory (ICH and GMP, for example) guidelines.Where appropriate,



perform method suitability or full method validationTimely data analysis and completion of reports3.Maintenance and Upkeep of Analytical EquipmentOrganize and/or perform routine and preventative maintenance and inspections on analytical equipment. These include: HPLC, LC-MS, GC-FID, GC-MS, ICP-MS, Karl-Fisher titrator, UV-Vis and other analytical and associated equipment.4.Quality ControlAbility to organize multiple tasks and work independently.Performing analysis according to established test methods and specifications.Reporting and ability to lead out of specification/ out of trend investigations with approvals from supervisor and QA.Ability to coordinate all aspects of a material testing program including outsourced testing requirements.Writing and review of SOPs and test methods, validation protocols and reports.Following all safety policies and maintaining a clean and orderly work area.Maintenance of documentation and data, including lab notebooks, equipment logbooks and analytical data. This includes organization and reporting of inventory of controlled substances and/or cannabis products as required by Health CanadaAny other duties which might arise during the course of a project.Key Requirements:To be successful in this role, the ideal candidate should possess the following qualifications and skills:University degree or equivalent in science or engineering.3+ years' experience in a pharmaceutical company or equivalent regulated analytical laboratory settingExperience and knowledge of GMP regulations and/or other regulatory requirements for analytical testingExcellent oral/written communication and interpersonal/leadership skills.Must be willing and able to work in a structured work environment with regard to safety and consistent conformance to standard operating procedures and workplace practices.Demonstrated consistent performance in sophisticated analytical techniquesDemonstrated valuable documentation skillsAbility to obtain A/QPIC status (ie: security clearance) under Controlled Substance Dealers LicenseExperience with microbial product testing (enumeration of Total Aerobic Microbial Count, Total Yeast and Mold Count, Bile-Tolerant Gram-negative bacteria, presence/absence testing for E. coli, Salmonella spp, Staphylococcus aureus, etc..) by plating and/or qPCR an asset.Canadian citizen or permanent resident in CanadaKnowledge, Skills and Abilities:Science -- Use scientific rules and methods to solve problems.Active Learning -- Understand the implications of new information for both current and future problem solving and decision-making.Critical Thinking -- Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.Judgment and Decision Making -- Consider the relative costs and benefits of potential actions to choose the most appropriate one.Writing -- Communicate effectively in writing as appropriate for the needs of the audience.Speaking -- Talk to others to convey information effectively.Active Listening -- Give full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate timesEnglish Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.GMP background including laboratory notebook maintenance.CompensationAnnual salary range of $85,000 - $105,0003 weeks of annual vacationRelocation and accommodation support providedWhile we appreciate all those who apply, only those candidates selected for interview will be contacted.

📌 Senior Analytical Lab Specialist (Princeton)
🏢 Optimi
📍 Princeton