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Senior Scientist - LCMS

Title: Senior Scientist – R&D
Division / Dept.: Lab
Location: Office Based
Note: Full time, Benefits, Relocation Assistance Available
 
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies, and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose
Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates, and analyzes data and records data in adherence with PPD SOP's and the industry. 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 and communication of regulatory issues with senior level team members.
Essential Functions
·     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 and assists in troubleshooting instrument and analytical problems.
·     Assists with quality systems and new equipment.
·     Assists in designing method validation or method transfer protocols and establish project 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 the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
To learn how PPD can advance your career, apply now!

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Education and Experience


Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
 
PhD is equivalent to experience requirement
 
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
 
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
 
PPD Benefits Overview
PPD offers comprehensive benefits including medical, dental, vision, pharmacy, employee assistance program, wellness program options and more.


Additional Benefits
·     401k with matching contributions, life insurance, long term and short-term disability insurance, flexible medical and dependent care spending accounts.
·     Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holidays, and vacation sell back program.
·     Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.
·     Education reimbursement and tuition assistance programs, professional development training, skills training, education loan repayment plan, dependent  scholarship program and more.
·     Employee appreciation events, service recognition awards, annual reviews, merit plans and bonus plans
·     Community connections and activities including philanthropic engagement, volunteer service projects and more
·     Other great options including pet insurance, legal and financial services plan, auto and home insurance discounts.
 
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.