Associate Scientist II

BioIVT•Detroit, MI

3d•Onsite

About The Position

Under general supervision, performs a variety of laboratory procedures to support biological sample preparation, processing, and product manufacturing. Responsibilities include sterile techniques, solution preparation, nucleic acid isolation, tissue processing, cell culture maintenance, cryopreservation, and characterization of biological samples. Conducts routine experiments, product isolation, and kit validation under supervision. May perform small animal surgeries, necropsies, and organ harvesting as applicable. Maintains accurate documentation, ensures compliance with safety and regulatory standards, and performs general laboratory upkeep, equipment maintenance, and inventory management. This role encompasses all duties of the Associate Scientist I position and may involve advanced processing techniques, requiring specialized protocols, sensitive equipment and greater independence. This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.

Requirements

Bachelor’s degree (B.S./B.A.) plus two (2) years related laboratory experience, or equivalent combination of experience and education.
Proficiency in a variety of computer software programs including MS Office
Ability to work in a team laboratory environment with knowledge or familiarity with scientific terminology.
Experience using sterile technique and familiarity with elementary cell and tissue culture and biomedical principles as they relate to the isolation and culturing of hepatocytes and /or preparation of subcellular fractions.
Demonstrated ability to coordinate multiple processes and manage deadlines, working autonomously and under pressure with highly developed organizational skills.
Ability to apply concepts such as fractions, percentages, ratios, algebra and proportions to practical situations.
Ability to perform routine calculations as directed.

Nice To Haves

Bachelor’s degree in biological or chemical science field, preferred.

Responsibilities

Perform routine laboratory functions: sterile techniques, diluting, labeling and dispensing of biological samples, solution preparation, weighing, laboratory upkeep, washing glassware, and cleaning.
Prepare and process biological-derived samples and perform product isolation.
Conduct nucleic acid isolations, including dissecting samples, performing sample lysis, and isolating nucleic acids.
Prepare cellular and subcellular fractions from tissues, including necropsy procedures, tissue processing, and centrifugation.
Maintain cultured cells and perform cryopreservation of cells.
Performs routine product manufacturing experiments under indirect supervision, following established protocols and quality standards; conducts atypical experiments under direct supervision.
Administers controlled substances and perform small animal surgery, including organ harvesting, as applicable by site/discipline.
Weigh tissues during animal necropsy procedures, as applicable to site or discipline.
Conducts quality control evaluations on various biological samples under indirect supervision; troubleshoots errors under direct supervision.
Maintain accurate and complete records of procedures performed. Document all procedures in accordance with company policies, regulatory requirements, and industry best practices. Ensure records are clear, detailed, and entered promptly into the appropriate systems or logs. Maintain confidentiality of all data, and verify that documentation supports quality control, compliance audits, and operational reporting. Regularly review and update records to ensure accuracy and completeness.
May assist with inventory counts in accordance with established company policies and procedure, as applicable to site/discipline.
Accurately pick and assemble components into kits, print and label components, track and order consumables as applicable to site/discipline.
Conduct kit validation for custom projects and custom isolations as applicable by site/discipline.
Perform general upkeep of laboratory, including simple maintenance of equipment and inventory of consumable supplies.
Maintain a clean and orderly processing environment, practice safe work habits, ensure that all safety guidelines are strictly followed while complying with all safety, health, and environmental rules and regulations.
May assist with training incoming and/or developing Scientist, may serve as a manufacturing subject matter expert (SME) for one or more product lines.