Location: Kalamazoo, MI
Salary: 50000 - 60000
Microbiologist, is responsible for supporting all activities, as well as, performing routine testing (as needed) to support the Microbiology laboratory. The Microbiologist has an in depth knowledge of Microbiology that allows him/her to lead projects involving complex issues that overlap process and microbiological testing. The Microbiologist will have leadership responsibilities for validating, troubleshooting and transferring microbiological data. The position requires a sound background in biology and industrial microbiology. Experience with developing and validating microbiology-based methods as well as other standard microbiological techniques.
This individual will support, provide recommendations and implement Non-Conformance Report (NCR) and lab investigation corrective actions to support a compliant laboratory. This individual will qualify lab equipment and support equipment calibration, preventive maintenance, and service plans. This individual will perform appropriate training of laboratory employees in their job functions, and provide quality systems and task training. This individual will also provide oversight and assist activities of more junior personnel as required by laboratory management.
RESPONSIBILITIES AND DUTIES:
•Perform microbiological and cell based assays within the QC function.
•Write protocols, reports and transfer documentation to allow transfer of assays between Development and QC.
•Perform routine microbiological testing of raw materials, in-process and finished product in compliance with the requirements of the Health and Safety policy.
•Provide accurate and reliable laboratory assay results to cGMP standards, in compliance with current regulatory requirements and SOPs.
•Ensure that activities are performed according to current SOPs and for informing QC Manager of any deviations.
•Ensure appropriate standards of housekeeping, safety and discipline are applied within his/her working activities.
•Perform additional testing if required in other departments.
•Assist in co-ordination of daily activities in the Microbiology laboratory.
•Responsible for Fermentation microbiology upstream -including inoculum development and fermenter in process quality.
•Responsible for the accurate recording, review and storage of laboratory generated data.
•Responsible for compliance with all company systems and procedures.
•Bachelor's degree in Microbiology, Biology or closely related field is required. This position requires a minimum of 7+ years of work experience in a Microbiology laboratory.
Knowledge, Skills, and Abilities
•Should have good exposure to fermentation technology.
•The ideal candidate has worked in a quality control capacity as a microbiologist with biological products.
•Should have practical skills in fundamental microbiology and microbiological techniques.
•Previous experience regarding pre-sterile microbial load studies, sterility testing, bacterial endotoxin testing, on specialized substrates is preferred.
•The candidate must have excellent written and oral communication skills.
•Experience preparing of validation protocols and reports and being able to effectively communicate to management and other functional areas on microbiological issues is required.
•Good organizational skills for leading teams and communicating timelines are required.
•Advanced computer skills specifically in Microsoft Word, Excel and Adobe Acrobat required.
Work with team at Davis location to develop raw material specifications.
•Work with Process Engineering and Process Implementation team to design and implement manufacturing process from inception to completion.
•Follow cGMP practices and develop plan to train the staff for cGMP practices.
•Other duties as assigned.
•May require flexible hours for initial setup of testing.
•May require up to 25% travel.
ESSENTIAL MENTAL AND PHYSICAL FUNCTIONS:
•Handling various chemical products, some of which have some level of hazard, such as solvents.
•A certain degree of manual dexterity in order to manipulate testing instruments and good visual acuity to withstand hours of testing observations.
•A fair amount of time sitting down and inputting test result data and writing up final reports on a computer will be required.
•An ability to lift 30 pounds is also required.
The individual should appreciate our entrepreneurial, fast-paced, agile, and dynamic work setting. He/she should be enthusiastic and energetic, goal-driven, and highly motivated to complete tasks in a timely, efficient manner. The candidate should also thrive in a strong team environment, be a self-starter and comfortable speaking up in company meetings. An individual who is positive, interactive, resourceful and creative in problem solving by thinking "out of the box" will be highly valued in this role.
This job and many more are available through The Judge Group. Find us on the web at www.judge.com