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 - 90K/yr (possibly higher) 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 [email protected] 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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