myGwork - LGBTQ+ Business Community
Sr. Scientist - ICD
myGwork - LGBTQ+ Business Community, Richmond, Virginia, United States, 23214
Work Schedule
Standard (Mon-Fri)
Environmental Conditions Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description Performs complex laboratory analysis of pharmaceutical products and proficiently uses analyticalinstrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and theindustry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project andcommunication of regulatory issues with senior level team members. EssentialFunctions • Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision. • Prepares study protocols, project status reports, final study reports and other project-related technical documents. • Communicates data and technical issues to the client and responds to client needs and questions. • Mentors, trains and coordinates laboratory activities of other team members andassists in troubleshooting instrument and analytical problems. • Assists with quality systems and new equipment. • Assists in designing method validation or method transfer protocols and establishproject timelines. • Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of thedata for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • Preferred experience with ELISA, Ligand-binding assays, ECL, MSD, Method development and Validations. • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities: • Solid understanding and knowledge of general chemistry and separation science • Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance • Ability to utilize Microsoft Excel and Word to perform tasks • Proficiency on technical operating systems • Proven problem solving and troubleshooting abilities • Effective oral and written communication skills • Proven ability in technical writing skills • Time management and project management skills • Ability to work in a collaborative work environment with a team • Proven problem solving and troubleshooting abilities • Ability to train junior staff Working Conditions and Environment: • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. • Occasional drives to site locations, occasional domestic travel. • Exposure to biological fluids with potential exposure to infectious organisms. • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. • Occasional mobility needed. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance.
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Environmental Conditions Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description Performs complex laboratory analysis of pharmaceutical products and proficiently uses analyticalinstrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and theindustry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project andcommunication of regulatory issues with senior level team members. EssentialFunctions • Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision. • Prepares study protocols, project status reports, final study reports and other project-related technical documents. • Communicates data and technical issues to the client and responds to client needs and questions. • Mentors, trains and coordinates laboratory activities of other team members andassists in troubleshooting instrument and analytical problems. • Assists with quality systems and new equipment. • Assists in designing method validation or method transfer protocols and establishproject timelines. • Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of thedata for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • Preferred experience with ELISA, Ligand-binding assays, ECL, MSD, Method development and Validations. • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities: • Solid understanding and knowledge of general chemistry and separation science • Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance • Ability to utilize Microsoft Excel and Word to perform tasks • Proficiency on technical operating systems • Proven problem solving and troubleshooting abilities • Effective oral and written communication skills • Proven ability in technical writing skills • Time management and project management skills • Ability to work in a collaborative work environment with a team • Proven problem solving and troubleshooting abilities • Ability to train junior staff Working Conditions and Environment: • Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. • Occasional drives to site locations, occasional domestic travel. • Exposure to biological fluids with potential exposure to infectious organisms. • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. • Occasional mobility needed. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance.
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