Scientist - Biotech develop and conduct basic and applied research projects. Utilize advanced technologies to study biological, molecular and chemical processes. Being a Scientist - Biotech synthesize and analyze DNA, proteins and other molecules to develop new drugs, medical protocols, and products. Prepare technical papers and reports on findings. Additionally, Scientist - Biotech requires a PhD in area of specialty. Typically reports to a supervisor or manager. To be a Scientist - Biotech typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)
Job Overview: This individual performs rapid microbial methods for enumeration testing on probiotic strains and in finished formats (Capsules, tablets, stick pack etc.). They will create and execute the validation and suitability protocols for developed methods as per USP & ISO guidelines, so that methods can be used for routine analysis.
Duties/Responsibilities
· Support development of enumeration of probiotic strains and quantification of bacteria methods.
· Create method validation/verification protocol for new methods for enumeration/potency estimation.
· Perform identification of microorganisms as per USP general chapters / AOAC published method.
· Perform enumeration testing of probiotic raw materials and finished products (Tablets, Capsules, stick packs, etc.) with or without herbal components for routine samples, using Flow Cytometer and plate counting.
· Generate graphs based on stability of probiotic strains and predict kinetics in degradation patterns.
· Establish relationship between AFU vs CFU vs TFU.
· Maintain notebooks and lab records within GMP standards and as per SOPs and guidelines.
· Comply with Health, Safety, and Environmental responsibilities for the position.
· Discuss methods, technology, and new methods of development with QA to meet customer requirements.
· Communicate with supplier or USP to discuss raw material and finished product methods.
· Verify ATCC Culture identification and population. Perform sample entry and results recording transactions.
· Prepare SOPs for new methods and equipment in the laboratory.
· Document microbial lab-related data as per GDP and recover documents for GMP audits or customer requests.
· Maintain purchase orders for all laboratory processes and monitor inventory.
· Communicate with third-party vendors to transfer methods for further validation.
· Communicate methods for article/Journal publications.
Qualifications
· Excellent written and verbal communication skills
· Ability to work independently or as part of a team.
· Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11
· Experience with rapid microbial testing procedures is an advantage.
Education and Experience
· MS/PhD in Microbiology/Biotechnology/Life Sciences or related scientific disciplines.
· Experience with different bacterial strains.
· Knowledge of Flow Cytometry and Colony Counting/plate counting.
Physical Requirements
● Must be able to lift 30 pounds.
● Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses, & respirator.
Job Type: Full-time
Pay: $55,000.00 - $70,000.00 per year
Benefits:
Schedule:
Ability to Relocate:
Work Location: In person
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