Scientist II, Microbiologist

High Point, NC is a commercial manufacturing and development site focusing on gelatin based drug delivery dosage forms (softgels). High Point is a Softgel Center of Excellence since 1996, offering extensive development and commercial scale capabilities for a variety of softgel technologies.

Location: 4125 Premier Drive, High Point, NC 27265

Discover Impactful Work:

The Microbiology Analyst II is responsible for the complete testing and results documentation, for any of the following: Environmental Monitoring, Purified Water, Raw Materials, In-Process, Finished Product, Calibrations, Stability, AD, and Technical Service samples or projects within the QC Microbiology Laboratory, in a manner consistent with established standards.

Day in the Life:

Up to 10%       Calibrations/ Standardizations/ Preparatory Set Up:

• Perform calibrations of instrument such as balances, pH meters and Water Activity Meter if needed as required by Patheon/ThermoFisher Work Instructions.
• Performs Growth Promotion, and Suitability Testing including Associated reports.
• Prepare media, collect purified water for testing and use the Autoclave for waste disposal.
• Quarterly Environmental and Purified Water Reports

Up to 80%       Testing/Documentation:

• Independently perform core techniques or methods as assigned for testing on raw materials, in-process, release, stability, environmental or technical service samples or projects as assigned.
• Demonstrate proficiency in Microbiological Testing and understanding.
• Ensure that the calibration of critical laboratory equipment is current before use.

Up to 5%         Housekeeping:

• Clean (5s) and organize all laboratory areas including benches, sinks, drawers, cabinets, solvent cabinets, refrigerators, freezers, and storage areas.
• Cleaning of Biological Safety Cabinets (BSC).
• Maintain laboratory instruments disposing of wastes, cleaning them and replacing consumable parts as required.
• Dispose of solvent, acids and other wastes according to Patheon/Thermo Fisher procedures and local regulations. Clean Biohazard Containers.

Up to 5%         Training and Development

Participate in ongoing training for the development of skills and responsibility with an emphasis on technology.  Assist in the training of other analysts in areas of expertise.  The Analyst II must be able to actively participate on various laboratory projects or teams and propose solutions to problems encountered by such teams.

Keys to Success:

Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry or related field, with a minimum of 2 years of related experience in an analytical laboratory setting, preferably in a Quality Control Laboratory in a GMP facility, or a Masters Degree with a minimum of 1 year of related experience.

KNOWLEDGE, SKILLS, ABILITIES:

• Ability to operate some or any of the laboratory equipments, such as microscope, autoclave, incubators, water baths, analytical balances.  Possess manual dexterity to use pipets, volumetric flasks, and general glassware, laboratory instruments and fragile accessories.  Ability to use a PC and the following software: Microsoft Word, Excel.
• Strong mathematical skills.
• Must demonstrate a high level of commitment to delivering timelines and milestones to achieve business objective.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Excellent communication and listening skills
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
• Must comply with PSG Controlled Substance Policy and meet applicable DEA security clearance requirements if requested.

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in the United States now and in the future, without sponsorship.

• Must be able to pass a comprehensive background check, which includes a drug screening