MicrobiologistOctober 22, 2018
Analytical ChemistOctober 22, 2018
Gala Pharmaceutical Inc. (OTC:GLPH) is seeking a Laboratory Director for they Analytical Chemistry Laboratory. The laboratory director reports directly to the Chief Scientific Officer and will oversee all technical aspects of the laboratory which include all technical steps in the processing and analysis of samples, QA/QC, internal auditing. The director oversees all the day-to-day operations involved with the collection, processing, and analysis of analytes. Must have excellent critical thinking skills and project management skills (PMP certificate a plus). The director must have experience managing the daily operations of an ISO17025 certified laboratory under GLP standards. Experience working in a DEA Schedules 1-5 laboratory is preferred.
Duties and Responsibilities:
- Responsible for all technical operations of the Laboratory
Must be accessible 7 days a week either on-site or by phone to address any laboratory issues
Has knowledge of GLP standard
- Has knowledge of ISO17025
- Has knowledge of DEA Schedules and Drug Codes
Processes samples as needed
- Perform analysis as needed
- Maintain current knowledge of the science surrounding these testing services and the regulatory environment.
- Ensure compliance with all regulatory agencies including but not limited to FDA, DEA, CABCC, ISO17025
- Trains all new technical staff
- Selects and validates any new equipment for the Laboratory
- Continuing education in all areas related to the testing services provided by the laboratory.
- Ensures the facility is as technologically advanced as financially possible
- Reviews and approves and signs off on all technical processes and procedures in the laboratory.
- Reviews and approves and signs off on all Quality Control activities in the Laboratory.
- Document the review of all cell therapy products, equipment, consumables and testing.
- Approves all purchasing for the laboratory with oversight by the Chief Scientific Officer.
- Orders all laboratory supplies and ensures that there is at least a month worth of lab supplies on-hand
- Works closely with the Chief Scientific Officer to ensure regulatory compliance .
- Investigates all adverse events, errors and complaints and documents this investigation and determine the root cause.
- Periodically audits the staff during process to ensure compliance with SOPs.
- Designs validation experiments as necessary to validate new processes or procedures or changes to current processes and procedures.
- Analyzes all data/results
- Reviews all SOPs and quality documents on a quarterly basis
- Approves any changes to the technical SOPs
- Communicates regularly with the Chief Scientific Officer, notifying him of any problems or concerns
- Reviews contracts for new laboratory services
- Responsible for ensuring that all preventative maintenance is performed on all the equipment at the scheduled times
- Manage the technical staff.
- Provides technical guidance to the facility with respect to any technical questions or new services
- Must be articulate and be able to communicate both orally and in written documents
- Must be able to understand complex documentation.
- Must have training relevant to analytical chemistry
- Responds to any facility alarms 24 hours a day
- Other duties as assigned
- Laboratory instrumentation experience (3-5+ years) with Agilent and Thermo-Scientific
- Sample processing and testing preferred or food safety/environmental lab background
- Experience in Analytical Chemistry
- Experience with LIMS
- Bachelors in the Sciences (preferably Biological Science, Horticulture, Organic Chemistry); Master Degree’s preferred
- Experience in ICP-MS (Required)
- Experience in HPLC/GC-MS (Required)
- Experience in Pesticide Testing , LC-MS-MS (Required)
- Background work in an ISO17025 laboratory a plus
- Proper pipetting technique
- Basis Statistics
- ICP-MS: 3 years (Required)
- Laboratory Information Management System: 2 year (Required)
- GC-MS: 3 years (Preferred)
- High-performance Liquid Chromatography: 2 years (Required)
- qPCR (a plus)
- Laboratory: 5 years (Required)
Education and Certification:
- Bachelor’s (Required)
- Master’s (Preferred)
- PhD (Ideal)
- PMP certificate (Preferred)
- Competitive Salary
- Medical and Dental
- Maternity Leave
- Paternity Leave
- Paid Time OFF (PTO)
- Job Type: Full-time
The successful candidate(s) for this position will be subject to a pre-employment background check.