Associate Research Scientist - Validation Analyst/Scientist(ASCP) - 148348
Location: Highland Heights, KY(Relocation Assistance provided)
Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies.
Performs method testing and validations for new testing with PPD's Central Labs. Calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client.
Routinely acts as the technical project leader for multiple projects, interacts with clients (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.
Qualifies new lab instruments against lab procedures and and validates accurate results to be used for routine testing.
Education and Experience:
B.S. in Chemistry, Biology, Biochemistry, Immunology or related science field and 5+ years in new test validation or R&D experience in a CRO, clinical lab or regulated laboratory environment(CAP/CLIA)
An additional 2+ years experience required for higher levels.
Candidates with Medical Laboratory Scientist(MLS) accreditation
or other ASCP(MT) certifications are highly preferred.
Knowledge, Skills and Abilities:
Draft validation plans and validation reports for FDA approved verification and research use only (RUO) validation studies.
Experience performing and writing validation plans and summaries for immunoassays, and automated chemistry urinalysis in a high throughput environment.
Candidates with experience in regulated CAP, CLIA, NYS, FDA, GLP, GMP environments are highly preferred.
Follow analytical method validation best practices guidelines including the Clinical & Laboratory Standards Institute (CLSI) and CAP/CLIA regulatory requirements.
Ability to independently perform root cause analysis for method investigations
Working knowledge of common central laboratory instruments and operating systems is highly preferred
Proven problem solving and troubleshooting abilities
Proven ability in technical writing skills including writing SOPs
Time management and project management skills
Good written and oral communication skills
Candidates with high-throughput clinical laboratory experience in a research and development team are highly preferred
Additional clinical chemistry laboratory subspecialties of interest include: molecular virology, microbiology, and flow cytometry
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.
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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Key words: Medical Technologist, Med Tech, MLT, MLS, ASCP, RT-PCR, ELISA, FLOW, Molecular assays, RUO Assays, Highland Heights, Cincinnati, OH, KY, Clinical,
Organization - Operations
Primary Location - North America-United States-Kentucky-Highland Heights