Scientist, LTS, Microbiology - Rochester MI Job Listing at Kelly Services in Rochester, MI (Job ID US3564828_BH9840696)

Description

Scientist, Laboratory Technical Services, Microbiology – Rochester MI

Kelly Science & Clinical has a new, permanent opportunity for a Scientist, Laboratory Technical Services, Microbiology, in Rochester, MI!


Salary range: $80 – 120K/yr and based on experience. Relocation support offered too!
Summary: The Senior Scientist, Laboratory Technical Services, Microbiology, is primarily responsible for supporting the microbiological testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. This person has complete understanding/proficiency and takes a supporting role in conducting all types of microbiological/biological analyses (including the most complex analyses) using all equipment. This position will have a support role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives and is considered a knowledgeable resource for these areas. Write and review SOPs, test methods, validation protocols and reports. The Senior Scientist is responsible for planning, designing, and execution of LTS activities, and assisting technical project teams of analysts and senior analysts.

Primary Responsibilities and Experience

• Analysis & Testing
• Develop, Validates analytical methods (i.e., Sterility test, BET, MLT, AET, Admixture study & other Microbiological analysis) for Finished Product and Raw Material release and stability testing.
• Evaluates, troubleshoots/improves existing analytical methods when necessary
• Prepares and review method validation protocols, reports, and analytical test methods
• Performs testing to support process and formulation development.
• Performs work to support project as assigned with little oversight
• Presents analytical data to project team for review and discussion
• Reviews and approves laboratory test data and documentation (e.g., notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary.
• Reviews and evaluates drug substance supplier's technical documents to ensure internal test requirements are adequate
• Uses laboratory software for analyses
• Is alert to and detects abnormalities during performances of tests and reviews
• To execute/use of track wise and other document related software's. 65% Lab Equipment
• Evaluates new technologies to improve efficiencies and to reduce the cost of testing
• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, microbiological reagents inventory, document filing and housekeeping
• Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
• Troubleshoots instrumentation and performs subsequent analyses 20% Investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities
• Participates in root cause identification of complex laboratory investigations
• Writes, edits, and reviews SOPs and laboratory investigations 10% Training
• Provide training to sub-ordinates on microbiological/biological techniques
• Continuously updates knowledge with respect to the latest technologies related to microbiological/biological science
• Maintains assigned training records current and in-compliance
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and microbiological/biological theories, methodologies, and procedures. This includes but is not limited to Bioburden, Endotoxin, Anti-Microbial Potency, Sterility, Particulates, Organism Identification, and Raw Material, Finished Product, Stability testing.
• Identifies need for SOPs and writes or revises, as appropriate
• Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
• Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Takes active role in auditing laboratory logbooks/documentation to ensure compliance
• Follows internal processes related to controlled substances Safety
• Follows EH&S procedures to ensure a safe work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations, good documentation practice and/or MSDS Total 100%

Education/Background/Qualifications:

• Bachelor of Science Degree in Microbiology, Biotechnology, Biochemistry or related field with 6 years' relevant analytical laboratory experience OR Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR PhD in above disciplines with some relevant analytical laboratory experience preferred Knowledge
• Has strong knowledge of laboratory microbiology and has expanded knowledge of microbiological instrument's software (e.g., Vitek 2 compact system, Microscope, Steam sterilizer, sterility closed system etc.)
• Full proficiency with various laboratory techniques/instruments: Sterility testing, Kinetic turbidometry (BET), Microscopy, Vitek identification system, pH meter, analytical balance, etc.
• Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
• Has demonstrated competence in conducting microbiological analyses
• Strong knowledge of microbiological techniques
• Competency in Microsoft Office Suite Skills & Abilities
• Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
• Ability to display and analyze data in a logical manner
• Strong verbal and written communication skills as well as good computer skills
• Strong attention to details and accurate record keeping
• Establish and maintain cooperative working relationships with others
• Solid organizational skills
• Ability to coach less senior staff and develop laboratory skills and ability
• Ability to take initiative, set priorities and follow through on assignments

For more information or to be considered, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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