Associate Scientist II

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned.

Perform routine laboratory functions:

sterile techniques, diluting, labeling and dispensing of biological samples, solution preparation, weighing, laboratory upkeep, washing glassware, and cleaning. Under indirect supervision, 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 Under indirect 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. Under supervision, 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. Under direct supervision may assist with training incoming and/or developing Scientist, may serve as a manufacturing subject matter expert (SME) for one or more product lines.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and/or Experience Bachelor's degree (B.S./B.A.) plus two (2) years related laboratory experience, or equivalent combination of experience and education. Bachelor's degree in biological or chemical science field, preferred. Other Skills and Abilities 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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to: stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 5 pounds and occasionally lift and/or move up to 30 pounds.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. A full-time Monday through Friday workweek with general business hours. This position may serve on the On-Call Team and will work rotating weekends and occasionally work evening hours. While performing the duties of this job, frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids, and risk of radiation. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both in heat/cold, wet/humid, and dry/arid conditions. The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.